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Trial record 23 of 39 for:    "Spinal Disease" | "Benzocaine"

A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis

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ClinicalTrials.gov Identifier: NCT02437162
Recruitment Status : Terminated (Neither dose achieved the study's primary or major secondary endpoints. The safety profile was consistent with previous ustekinumab studies.)
First Posted : May 7, 2015
Results First Posted : April 23, 2018
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Axial Spondyloarthritis
Interventions Drug: Placebo
Drug: Ustekinumab 45 mg
Drug: Ustekinumab 90 mg
Drug: Golimumab 50 mg
Enrollment 347
Recruitment Details  
Pre-assignment Details A total of 347 participants were randomized, and 346 participants were treated (116 participants to placebo, 116 participants to ustekinumab 45 mg, and 114 participants to 90 mg).
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100. Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind. Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Period Title: Overall Study
Started 116 116 115
Treated 116 116 114
Early Escape at Week 16 26 [1] 21 [1] 14 [1]
Cross Over at Week 24 87 [2] 0 0
Completed 9 8 6
Not Completed 107 108 109
Reason Not Completed
Protocol Violation             0             1             0
Randomized but not treated             0             0             1
Study discontinued by Sponsor             93             98             97
Withdrawal by Subject             13             7             9
Adverse Event             0             1             0
Lost to Follow-up             1             0             1
Death             0             1             0
Other             0             0             1
[1]
Study discontinuation/completion reported under randomization group
[2]
Out of 87: crossed over to Ustekinumab 45 mg (n=44) and Ustekinumab 90 mg (n=43)
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg Total
Hide Arm/Group Description Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100. Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind. Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind. Total of all reporting groups
Overall Number of Baseline Participants 116 116 114 346
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included all participants who were randomized and received at least one administration of study agent.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 116 participants 116 participants 114 participants 346 participants
38.3  (11.35) 39.2  (10.5) 39.5  (11.32) 39  (11.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 116 participants 114 participants 346 participants
Female
15
  12.9%
23
  19.8%
14
  12.3%
52
  15.0%
Male
101
  87.1%
93
  80.2%
100
  87.7%
294
  85.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 116 participants 114 participants 346 participants
Hispanic or Latino
4
   3.4%
0
   0.0%
1
   0.9%
5
   1.4%
Not Hispanic or Latino
112
  96.6%
116
 100.0%
113
  99.1%
341
  98.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 116 participants 114 participants 346 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
30
  25.9%
32
  27.6%
31
  27.2%
93
  26.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   0.9%
1
   0.3%
White
86
  74.1%
84
  72.4%
82
  71.9%
252
  72.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 116 participants 114 participants 346 participants
Asian
30
  25.9%
32
  27.6%
31
  27.2%
93
  26.9%
Black or African American
0
   0.0%
0
   0.0%
1
   0.9%
1
   0.3%
Hispanic or Latino
4
   3.4%
0
   0.0%
1
   0.9%
5
   1.4%
White Non-Hispanic
82
  70.7%
84
  72.4%
81
  71.1%
247
  71.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 116 participants 114 participants 346 participants
Poland
19
  16.4%
14
  12.1%
17
  14.9%
50
  14.5%
Ukraine
19
  16.4%
20
  17.2%
22
  19.3%
61
  17.6%
United States
2
   1.7%
2
   1.7%
1
   0.9%
5
   1.4%
Russia
32
  27.6%
38
  32.8%
31
  27.2%
101
  29.2%
Korea, Democratic People'S Republic Of
9
   7.8%
11
   9.5%
9
   7.9%
29
   8.4%
Taiwan, Province Of China
23
  19.8%
21
  18.1%
23
  20.2%
67
  19.4%
Czech Republic
12
  10.3%
10
   8.6%
11
   9.6%
33
   9.5%
1.Primary Outcome
Title Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24
Hide Description ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40 percent (%) and absolute improvement from baseline of at least 2 on 0 to 10 centimeter (cm) scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation(0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
28.4 31.0 28.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 45 Milligram (mg)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.669
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value 2.586
Confidence Interval (2-Sided) 95%
-9.138 to 14.310
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Ustekinumab 90 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.913
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage difference
Estimated Value -0.646
Confidence Interval (2-Sided) 95%
-12.180 to 10.887
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Week 24
Hide Description ASAS 20 defined as improvement from baseline of >= 20% and with an absolute improvement from baseline of 1 on a 0 to 10cm scale in at least 3 of following 4 domains:Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain(0 to 10cm; 0=no pain,10=most severe pain),Bath Ankylosing Spondylitis Functional Index (BASFI) (self-assessment represented as mean(0 to 10 cm; 0=easy to 10=impossible) of 10 questions,8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life, Inflammation (0 to 10cm;0=none,10=very severe);absence of deterioration from baseline(>= 20% and worsening of at least 1 on a 0 to 10 cm scale) in the potential remaining domain. ASAS 20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
44.8 55.2 50.0
3.Secondary Outcome
Title Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
Hide Description BASDAI used to measure ankylosing spondylitis (AS) disease severity. Consists of 6 questions: fatigue,spinal pain,arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons, ligaments),morning stiffness(MS) (2 questions:duration, severity). Each question is easy to answer 10cm VAS, 0(none),10(very severe) and for the last question related to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each 5 symptoms equal weight, mean of 2 questions about MS added to total of remaining 4 scores,final BASDAI score(ranging 0-10) is average of overall total score. Higher BASDAI indicates more severe AS symptom. 50% improvement from baseline based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rule(consider non-responder at W20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
27.6 25.0 25.4
4.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24
Hide Description The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 88 95 99
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.85  (2.133) -2.11  (2.266) -2.07  (2.502)
5.Secondary Outcome
Title Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24
Hide Description ASDAS includes CRP milligram per liter(mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* DMS) + (0.579*Ln(CRP+1). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 [normal] to 10 [very severe]) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responder).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
3.4 1.7 2.6
6.Secondary Outcome
Title Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Hide Description Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied(measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Milligrams per deciliter (mg/dL)
Change at Week 4 Number Analyzed 115 participants 116 participants 113 participants
-0.10  (1.459) -0.54  (1.488) -0.74  (1.839)
Change at Week 8 Number Analyzed 116 participants 115 participants 114 participants
-0.16  (1.478) -0.59  (1.236) -0.66  (2.213)
Change at Week 12 Number Analyzed 115 participants 115 participants 112 participants
-0.18  (1.571) -0.80  (1.853) -0.84  (2.262)
Change at Week 16 Number Analyzed 115 participants 116 participants 114 participants
-0.11  (1.456) -0.39  (3.166) -0.86  (2.261)
Change at Week 20 Number Analyzed 88 participants 93 participants 99 participants
-0.34  (1.450) -0.73  (1.792) -0.79  (2.240)
Change at Week 24 Number Analyzed 87 participants 95 participants 98 participants
-0.41  (1.737) -0.72  (1.617) -0.92  (2.274)
7.Secondary Outcome
Title Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) Total Score at Week 16 and 24
Hide Description Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Entheses were scored as either 0 (nontender) or 1 (tender) yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Population included subset of FAS with enthesitis at baseline. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 87 92 83
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 16 Number Analyzed 62 participants 59 participants 58 participants
-1.53  (3.347) -1.47  (3.564) -1.17  (3.101)
Change at Week 24 Number Analyzed 35 participants 38 participants 44 participants
-1.66  (3.481) -1.84  (3.301) -1.73  (3.060)
8.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 and 24
Hide Description The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are: 1)Tragus-to-wall; 2)Modified Schober (lumbar flexion); 3)Cervical rotation angle; 4)Lateral spinal flexion; 5)Intermalleolar distance. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient’s limitation of movement due to their AS. Early escape rule was applied (measurement value was set as missing).
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 16 Number Analyzed 114 participants 114 participants 111 participants
-0.26  (1.015) -0.26  (1.044) -0.17  (0.840)
Change at Week 24 Number Analyzed 87 participants 92 participants 97 participants
-0.36  (0.943) -0.37  (0.946) -0.27  (0.877)
9.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) Score at Week 16 and 24
Hide Description The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of “yes” on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL. Early escape rule was applied (measurement value was set as missing).
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 16 Number Analyzed 114 participants 116 participants 113 participants
-2.61  (4.385) -3.03  (4.416) -2.93  (3.954)
Change at Week 24 Number Analyzed 87 participants 94 participants 98 participants
-4.21  (4.441) -4.48  (4.808) -4.31  (4.537)
10.Secondary Outcome
Title Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 and 24
Hide Description The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Early escape rule was applied (measurement value was set as missing).
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 16 Number Analyzed 114 participants 116 participants 113 participants
5.71  (9.499) 5.44  (9.528) 5.96  (9.325)
Change at Week 24 Number Analyzed 87 participants 94 participants 98 participants
8.78  (10.472) 7.67  (10.348) 8.59  (10.597)
11.Secondary Outcome
Title Change From Baseline in Short Form-(SF)-36 Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS) at Week 16 and 24
Hide Description The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
SF-36 PCS; change at Week 16 Number Analyzed 114 participants 116 participants 114 participants
4.09  (7.618) 3.66  (6.172) 5.17  (6.494)
SF-36 PCS; change at Week 24 Number Analyzed 87 participants 94 participants 98 participants
7.69  (8.001) 6.34  (6.198) 7.20  (7.343)
SF-36 MCS; change at Week 16 Number Analyzed 114 participants 116 participants 114 participants
4.56  (9.113) 3.69  (9.690) 4.06  (9.034)
SF-36 MCS; change at Week 24 Number Analyzed 87 participants 94 participants 98 participants
5.05  (9.758) 4.82  (10.841) 5.46  (8.911)
12.Secondary Outcome
Title Change From Baseline in BASDAI Inflammation Score Through Week 24
Hide Description The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration, severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). Change from baseline in inflammation was assessed by calculating the average of the Last 2 Questions of the BASDAI Concerning Morning Stiffness. Early escape rule was applied (measurement value was set as missing).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 4 Number Analyzed 116 participants 116 participants 114 participants
-0.86  (1.650) -1.09  (1.748) -1.25  (1.871)
Week 8 Number Analyzed 116 participants 115 participants 114 participants
-1.45  (1.970) -1.80  (2.192) -1.88  (2.160)
Week 12 Number Analyzed 116 participants 115 participants 112 participants
-1.63  (2.110) -1.89  (2.143) -1.88  (2.110)
Week 16 Number Analyzed 115 participants 116 participants 114 participants
-1.82  (2.221) -1.98  (2.394) -1.97  (2.299)
Week 20 Number Analyzed 86 participants 92 participants 98 participants
-2.48  (2.200) -2.61  (2.089) -2.51  (2.429)
Week 24 Number Analyzed 88 participants 95 participants 99 participants
-2.64  (2.194) -2.81  (2.257) -2.74  (2.592)
13.Secondary Outcome
Title Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24
Hide Description Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, and Quantity of sleep(QS)/optimal sleep(OS) during the past 4 weeks. The six dimensions were also used to generate the composite Sleep Problems Index (SPI). An increase in score from baseline represents improvement. Sleep disturbance, snoring, somnolence, awaken short of breath, sleep problems index have score ranges from 0(no sleep problems) to 100 (greater sleep problems), negative change indicates improvement. Sleep adequacy scored 0 (least sleep adequacy) to 100 (better sleep adequacy), positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), positive change indicates improvement. Early escape rule was applied (measurement value was set as missing).
Time Frame Baseline, Week (W) 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at W16: sleep disturbance Number Analyzed 114 participants 116 participants 113 participants
3.15  (7.103) 4.13  (7.815) 2.79  (6.233)
Change at W24: sleep disturbance Number Analyzed 88 participants 94 participants 98 participants
4.57  (7.335) 5.85  (8.991) 4.79  (7.232)
Change at W16: somnolence Number Analyzed 114 participants 116 participants 113 participants
3.79  (7.996) 2.06  (7.901) 2.73  (8.525)
Change at W24: somnolence Number Analyzed 88 participants 94 participants 98 participants
4.99  (8.019) 3.16  (8.612) 4.52  (9.131)
Change at W16: sleep adequacy Number Analyzed 114 participants 116 participants 113 participants
1.78  (7.713) 1.42  (9.301) 1.50  (7.851)
Change-W24: sleep adequacy Number Analyzed 88 participants 94 participants 98 participants
3.03  (7.245) 1.75  (9.148) 3.41  (7.689)
Change at W16: snoring Number Analyzed 114 participants 116 participants 113 participants
0.47  (7.026) 1.24  (5.753) 1.14  (6.520)
Change at W24: snoring Number Analyzed 88 participants 94 participants 98 participants
0.86  (7.506) 1.21  (6.715) 2.64  (7.569)
Change at W16:awaken short of breath or headache Number Analyzed 114 participants 116 participants 113 participants
3.93  (12.209) 3.66  (11.355) 5.53  (12.602)
Change-W24:awaken short of breath or headache Number Analyzed 88 participants 94 participants 98 participants
3.48  (11.179) 2.76  (11.385) 3.97  (12.426)
Change at W16: sleep problems index Number Analyzed 114 participants 116 participants 113 participants
3.72  (7.341) 3.76  (8.160) 3.19  (6.695)
Change at W24:sleep problems index Number Analyzed 88 participants 94 participants 98 participants
5.10  (7.338) 4.96  (8.794) 5.16  (7.795)
14.Secondary Outcome
Title Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS)-Quantity of Sleep/Optimal Sleep at Week 16 and 24
Hide Description Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, QS/OS during past W4. 6 dimensions used to generate composite SPI. Increase in score from baseline represents improvement. Sleep adequacy scored 0 (least sleep adequacy[SA]) to 100 (better SA), positive change indicates improvement. QS is scored 0 (less QS) to 24 (greater QS), positive change indicates improvement. Single-item QS asks participants to estimate average number of hours they slept each night during past 4W (0-24 hours) and transformed into dichotomous OS Score, reported 7 (or 8) hours of sleep considered Optimal. OS is scored Yes if average hours of sleep is in range of 7-8 hours. Early escape rule was applied (measurement value was set as missing).
Time Frame Baseline, Week (W) 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Hours
Change-W16: quantity of sleep/optimal sleep Number Analyzed 114 participants 116 participants 113 participants
0.15  (0.502) 0.06  (0.548) 0.04  (0.557)
Change-W24: quantity of sleep/optimal sleep Number Analyzed 88 participants 94 participants 98 participants
0.16  (0.500) 0.07  (0.626) 0.12  (0.579)
15.Secondary Outcome
Title Percentage of Participants With at Least a 40% Improvement From Baseline in ASAS 40 Components at Week 24
Hide Description ASAS 40 components included Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe). Percentage of Participants With at least a 40% improvement from baseline in each of the ASAS components was calculated.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 114 115 113
Measure Type: Number
Unit of Measure: Percentage of participants
Patients global assessment 43.0 35.7 31.9
Total back pain 42.1 42.6 38.9
BASFI 32.5 33.0 35.4
Inflammation 47.4 36.5 37.2
16.Secondary Outcome
Title Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24
Hide Description BASDAI used to measure the AS disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer cm VAS with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, mean of 2 questions about morning stiffness will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 20 %,50%, 70%,90% improvement from baseline in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 (20% improvement) 25.9 28.4 35.1
Week 8 (20% improvement) 44.8 45.7 43.0
Week 12 (20% improvement) 47.4 45.7 41.2
Week 16 (20% improvement) 49.1 46.6 48.2
Week 20 (20% improvement) 43.1 51.7 50.0
Week 24 (20% improvement) 47.4 55.2 51.8
Week 4 (50% improvement) 3.4 4.3 5.3
Week 8 (50% improvement) 12.9 12.9 14.0
Week 12 (50% improvement) 19.0 12.9 14.0
Week 16 (50% improvement) 19.8 17.2 18.4
Week 20 (50% improvement) 25.9 17.2 22.8
Week 4 (70% improvement) 0.9 0.9 1.8
Week 8 (70% improvement) 6.9 4.3 5.3
Week 12(70 % response) 6.9 6.9 7.9
Week 16(70 % response) 10.3 9.5 8.8
Week 20 (70% improvement) 11.2 6.9 10.5
Week 24 (70% improvement) 11.2 11.2 11.4
Week 4 (90% improvement) 0 0.9 0
Week 8 (90% improvement) 0.9 0 1.8
Week 12 (90% improvement) 1.7 0.9 1.8
Week 16 (90% improvement) 1.7 1.7 0.9
Week 20 (90% improvement) 2.6 0.9 1.8
Week 24 (90% improvement) 4.3 1.7 4.4
17.Secondary Outcome
Title Change From Baseline in BASDAI Total Score Through Week 24
Hide Description The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 116 participants 116 participants 114 participants
-0.83  (1.340) -0.92  (1.550) -0.87  (1.632)
Change at Week 8 Number Analyzed 116 participants 115 participants 114 participants
-1.43  (1.849) -1.67  (1.984) -1.49  (2.025)
Change at Week 12 Number Analyzed 116 participants 115 participants 112 participants
-1.59  (2.073) -1.64  (2.047) -1.45  (2.118)
Change at Week 16 Number Analyzed 115 participants 116 participants 114 participants
-1.67  (2.271) -1.74  (2.300) -1.60  (2.276)
Change at Week 20 Number Analyzed 86 participants 92 participants 98 participants
-2.35  (2.226) -2.39  (1.922) -2.20  (2.283)
Change at Week 24 Number Analyzed 88 participants 95 participants 99 participants
-2.52  (2.262) -2.56  (2.196) -2.40  (2.356)
18.Secondary Outcome
Title Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20
Hide Description ASAS 40 defined as improvement from baseline of greater than or equal to (>=) 40% and with an absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame Week 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 7.8 6.9 8.8
Week 8 14.7 18.1 19.3
Week 12 19.8 14.7 18.4
Week 16 22.4 21.6 22.8
Week 20 22.4 22.4 28.9
19.Secondary Outcome
Title Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20
Hide Description ASAS 20 defined as improvement from baseline of greater than or equal to (>=) 20% and with an absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in the potential remaining domain. ASAS20 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame Week 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 20.7 27.6 29.8
Week 8 33.6 41.4 42.1
Week 12 37.1 44.8 39.5
Week 16 44.0 45.7 43.9
Week 20 39.7 46.6 49.1
20.Secondary Outcome
Title Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24
Hide Description Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient’s global assessment of disease activity, total back pain, function (BASFI), inflammation. ASAS partial remission response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 1.7 0 0.9
Week 8 3.4 0.9 3.5
Week 12 4.3 4.3 3.5
Week 16 8.6 5.2 2.6
Week 20 7.8 3.4 6.1
Week 24 6.9 5.2 6.1
21.Secondary Outcome
Title Percentage of Participants Who Achieved ASAS 5/6 Response at Week 16 and 24
Hide Description ASAS 5/6 is defined as a >=20% improvement in any 5 of the 6 domains of pain (VAS 0 to 10), patient global (VAS 0 to 10), function (BASFI score), morning stiffness (from BASDAI), hsCRP, and spine mobility (lumbar side flexion). ASAS 5/6 response is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Time Frame Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 16 23.3 29.3 26.3
Week 24 30.2 35.3 33.3
22.Secondary Outcome
Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24
Hide Description ASDAS includes CRP mg/L; 4 additional self-reported items (rated 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP)+(0.110*PGA) + (0.073*peripheral pain(PP)/swelling)+(0.058* duration of morning stiffness)+(0.579*Ln(CRP+1)). The disease activity, TBP, and PP/swelling on a NRS(0[normal]-10[very severe]and DMS on NRS(0 to 10, 0 being none and 10 representing a duration=>2 hours). The scores were categorized as: inactive disease (< 1.3), moderate (1.3 - < 2.1), high (2.1 - 3.5) and very high disease activity (> 3.5). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity. Early escape rule was applied (measurement value was set as missing).
Time Frame Baseline, Week 4, 8, 12 ,16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 113 participants 116 participants 113 participants
-0.41  (0.705) -0.52  (0.616) -0.55  (0.673)
Change at Week 8 Number Analyzed 114 participants 115 participants 114 participants
-0.62  (0.881) -0.80  (0.764) -0.75  (0.875)
Change at Week 12 Number Analyzed 113 participants 114 participants 112 participants
-0.66  (0.957) -0.87  (0.800) -0.76  (0.881)
Change at Week 16 Number Analyzed 113 participants 116 participants 114 participants
-0.67  (1.044) -0.85  (0.972) -0.80  (0.926)
Change at Week 20 Number Analyzed 84 participants 92 participants 98 participants
-1.00  (1.033) -1.13  (0.844) -1.01  (0.982)
Change at Week 24 Number Analyzed 85 participants 95 participants 98 participants
-1.10  (1.088) -1.19  (0.985) -1.12  (1.005)
23.Secondary Outcome
Title Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
Hide Description ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* duration of morning stiffness) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Time Frame Week 4, 8, 12, 16, and 20
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 0.9 0 0
Week 8 0.9 0.9 2.6
Week 12 1.7 0.9 0.9
Week 16 1.7 1.7 2.6
Week 20 4.3 0.9 2.6
24.Secondary Outcome
Title Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24
Hide Description ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058* DMS) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Major improvement in ASDAS is defined as a decrease from baseline >=2.0. ASDAS (CRP) major improvement (decrease >=2.0) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 2.6 3.4 3.5
Week 8 6.9 8.6 12.3
Week 12 8.6 9.5 12.3
Week 16 10.3 13.8 14.0
Week 20 7.8 15.5 10.5
Week 24 13.8 16.4 14.9
25.Secondary Outcome
Title Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24
Hide Description ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 NRS) included are TBP, duration of DMS, peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*TBP) + (0.110*participant global) + (0.073*peripheral pain/swelling) + (0.058*DMS) + (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Clinically important improvement in ASDAS is defined as a decrease from baseline >=1.1. ASDAS (CRP) clinical important improvement (decrease >=1.1) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 16.4 13.8 17.5
Week 8 26.7 31.0 30.7
Week 12 28.4 37.9 28.1
Week 16 32.8 35.3 28.1
Week 20 29.3 31.9 37.7
Week 24 37.9 40.5 37.7
26.Secondary Outcome
Title Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20
Hide Description The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 116 participants 116 participants 114 participants
-0.77  (1.635) -0.80  (1.359) -0.90  (1.524)
Change at Week 8 Number Analyzed 116 participants 115 participants 114 participants
-1.13  (1.841) -1.29  (1.904) -1.29  (1.841)
Change at Week 12 Number Analyzed 116 participants 115 participants 112 participants
-1.09  (2.015) -1.22  (1.854) -1.34  (2.001)
Change at Week 16 Number Analyzed 115 participants 116 participants 114 participants
-1.08  (2.179) -1.35  (2.113) -1.43  (2.125)
Change at Week 20 Number Analyzed 86 participants 92 participants 98 participants
-1.71  (2.160) -1.94  (1.946) -2.01  (2.291)
27.Secondary Outcome
Title Change From Baseline in Chest Expansion at Week 16 and 24
Hide Description Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. It is measured at the level of the fourth intercostal space in males, and just below the breasts in females. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: centimeter(cm)
Change at Week 16 Number Analyzed 114 participants 113 participants 111 participants
0.43  (7.899) 0.20  (2.209) -0.02  (2.240)
Change at Week 24 Number Analyzed 87 participants 92 participants 97 participants
-0.16  (2.370) 0.32  (1.939) -0.21  (2.232)
28.Secondary Outcome
Title Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24
Hide Description The total back pain and nighttime back pain was measured on a VAS (0 to 10 cm; 0 = no pain, 10 = most severe pain). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
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Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: centimeter
Change at Week 4: TBP Number Analyzed 116 participants 116 participants 114 participants
-1.13  (2.019) -1.15  (1.911) -1.52  (1.895)
Change at Week 4: NBP Number Analyzed 116 participants 116 participants 114 participants
-1.05  (2.270) -1.25  (1.835) -1.19  (2.082)
Change at Week 8: TBP Number Analyzed 116 participants 115 participants 114 participants
-1.80  (2.190) -1.78  (2.294) -2.20  (2.243)
Change at Week 8: NBP Number Analyzed 116 participants 115 participants 114 participants
-1.69  (2.264) -1.85  (2.122) -2.01  (2.517)
Change at Week 12: TBP Number Analyzed 116 participants 115 participants 112 participants
-1.81  (2.295) -1.70  (2.218) -1.84  (2.288)
Change at Week 12: NBP Number Analyzed 116 participants 115 participants 112 participants
-1.61  (2.342) -1.79  (2.127) -1.76  (2.554)
Change at Week 16: TBP Number Analyzed 116 participants 116 participants 114 participants
-1.80  (2.374) -1.87  (2.465) -2.07  (2.387)
Change at Week 16: NBP Number Analyzed 115 participants 116 participants 114 participants
-1.76  (2.506) -2.02  (2.541) -2.05  (2.606)
Change at Week 20: TBP Number Analyzed 86 participants 92 participants 98 participants
-2.73  (2.456) -2.74  (2.088) -2.69  (2.414)
Change at Week 20: NBP Number Analyzed 86 participants 92 participants 98 participants
-2.67  (2.602) -2.73  (2.246) -2.83  (2.804)
Change at Week 24: TBP Number Analyzed 88 participants 95 participants 99 participants
-2.80  (2.528) -2.90  (2.389) -2.77  (2.511)
Change at Week 24: NBP Number Analyzed 88 participants 94 participants 99 participants
-2.75  (2.597) -2.79  (2.367) -2.68  (2.960)
29.Secondary Outcome
Title Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24
Hide Description Participants assessed their disease activity using a 10 cm visual analog scale, with responses ranging from 0 (very well) to 10 (very poor). Early escape rule was applied (The measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 116 participants 116 participants 114 participants
-0.99  (1.727) -1.01  (1.677) -1.21  (1.645)
Change at Week 8 Number Analyzed 116 participants 115 participants 114 participants
-1.48  (2.086) -1.60  (2.039) -1.70  (2.096)
Change at Week 12 Number Analyzed 116 participants 115 participants 112 participants
-1.52  (2.043) -1.53  (2.100) -1.77  (2.088)
Change at Week 16 Number Analyzed 115 participants 116 participants 114 participants
-1.64  (2.259) -1.73  (2.564) -1.77  (2.293)
Change at Week 20 Number Analyzed 86 participants 92 participants 98 participants
-2.10  (2.272) -2.17  (2.225) -2.36  (2.283)
Change at Week 24 Number Analyzed 88 participants 95 participants 99 participants
-2.37  (2.298) -2.55  (2.664) -2.50  (2.379)
30.Secondary Outcome
Title Change From Baseline in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale (VAS) Score at Week 16 and 24
Hide Description The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 16 and 24
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Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 16 Number Analyzed 114 participants 116 participants 113 participants
11.49  (20.328) 11.26  (23.588) 13.36  (22.110)
Change at Week 24 Number Analyzed 87 participants 94 participants 98 participants
17.57  (20.251) 13.90  (26.132) 16.80  (22.181)
31.Secondary Outcome
Title Change From Baseline in EQ-5D Index Score at Week 16 and 24
Hide Description The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing death. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Week 16 Number Analyzed 114 participants 116 participants 113 participants
0.08  (0.138) 0.09  (0.154) 0.10  (0.139)
Week 24 Number Analyzed 87 participants 94 participants 98 participants
0.12  (0.137) 0.12  (0.168) 0.13  (0.153)
32.Secondary Outcome
Title Change From Baseline in Berlin Magnetic Resonance Imaging (MRI) Spine Score at Week 24
Hide Description The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation.
Time Frame Baseline and Week 24
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Hide Analysis Population Description
Population included subset of FAS with participants who did not meet early escape criteria and have both baseline and Week 24 MRI assessments.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 23 18 26
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.48  (2.053) -0.58  (2.343) -1.15  (2.323)
33.Secondary Outcome
Title Change From Baseline in Percent Work Time Missed Due to AS (Assessed by Work Productivity and Activity Impairment Questionnaire - Specific Health Problem [WPAI-SHP]) Through Week 24
Hide Description The WPAI-SHP is a 6-item questionnaire used to assess the degree to which a specified health problem (here "AS") affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent work time missed due to AS for each study arm are reported.
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 16 Number Analyzed 67 participants 67 participants 70 participants
-3.72  (26.092) -2.05  (26.625) -2.06  (26.486)
Change at Week 24 Number Analyzed 55 participants 56 participants 62 participants
-7.37  (16.925) -4.38  (22.562) -7.07  (22.081)
34.Secondary Outcome
Title Change From Baseline in Percent Impairment While Working Due to AS (Assessed by WPAI-SHP) Through Week 24
Hide Description WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem ("AS") affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent impairment while working due to AS for each study arm are reported.
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 16 Number Analyzed 67 participants 67 participants 70 participants
-16.87  (25.359) -5.97  (21.607) -17.57  (20.032)
Change at Week 24 Number Analyzed 55 participants 56 participants 62 participants
-22.00  (21.892) -13.57  (22.758) -19.68  (22.973)
35.Secondary Outcome
Title Change From Baseline in Percent Overall Work Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24
Hide Description WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. Questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent overall work impairment due to AS for each study arm are reported.
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 16 Number Analyzed 67 participants 67 participants 70 participants
-16.03  (26.281) -6.64  (23.976) -17.48  (20.811)
Change at Week 24 Number Analyzed 55 participants 56 participants 62 participants
-21.98  (21.042) -14.64  (24.300) -20.54  (24.271)
36.Secondary Outcome
Title Change From Baseline in Percent Non-work Activity Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24
Hide Description WPAI-SHP is6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent non-work activity impairment due to AS for each study arm are reported.
Time Frame Baseline, Week 16 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45 Milligram (mg) Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 116 116 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
Change at Week 16 Number Analyzed 114 participants 116 participants 113 participants
-14.74  (23.013) -13.45  (21.833) -17.52  (22.101)
Change at Week 24 Number Analyzed 87 participants 94 participants 98 participants
-21.72  (23.288) -21.49  (23.825) -21.73  (22.339)
Time Frame Approximately 2 years
Adverse Event Reporting Description The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
 
Arm/Group Title Placebo Only Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45 mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90 mg Only Ustekinumab 90mg to Golimumab
Hide Arm/Group Description Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape [EE]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100. Participants randomized to placebo SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward. Participants randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward. Participants randomized to placebo SC and then rerandomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward. Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. Participants randomized to ustekinumab 45 mg SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward. Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. Participants randomized to ustekinumab 90 mg SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.
All-Cause Mortality
Placebo Only Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45 mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90 mg Only Ustekinumab 90mg to Golimumab
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/116 (0.00%)      0/26 (0.00%)      0/44 (0.00%)      0/43 (0.00%)      0/116 (0.00%)      1/21 (4.76%)      0/114 (0.00%)      0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Only Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45 mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90 mg Only Ustekinumab 90mg to Golimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/116 (1.72%)      0/26 (0.00%)      2/44 (4.55%)      2/43 (4.65%)      3/116 (2.59%)      3/21 (14.29%)      2/114 (1.75%)      0/14 (0.00%)    
Eye disorders                 
Ocular Hypertension * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  1/43 (2.33%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Uveitis * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  1/21 (4.76%)  0/114 (0.00%)  0/14 (0.00%) 
Hepatobiliary disorders                 
Cholelithiasis * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  1/44 (2.27%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Infections and infestations                 
Appendicitis * 1 [1]  0/116 (0.00%)  0 0/26 (0.00%)  1/44 (2.27%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Cellulitis * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  1/114 (0.88%)  0/14 (0.00%) 
Injury, poisoning and procedural complications                 
Back Injury * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  1/21 (4.76%)  0/114 (0.00%)  0/14 (0.00%) 
Concussion * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  1/44 (2.27%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Ligament Sprain * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  1/44 (2.27%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Muscle Strain * 1 [2]  0/116 (0.00%)  0/26 (0.00%)  1/44 (2.27%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Subdural Haematoma * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  1/114 (0.88%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Intervertebral Disc Disorder * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  1/116 (0.86%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Osteoarthritis * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  1/116 (0.86%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Benign Salivary Gland Neoplasm * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  1/21 (4.76%)  0/114 (0.00%)  0/14 (0.00%) 
Nervous system disorders                 
Facial Paralysis * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  1/116 (0.86%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Ischaemic Stroke * 1 [1]  1/116 (0.86%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Vertebrobasilar Insufficiency * 1 [1]  1/116 (0.86%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
Renal and urinary disorders                 
Calculus Urinary * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  1/43 (2.33%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  0/14 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
[1]
MedDRA Version 20.0
[2]
MedDRA Version 20.0,
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Only Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45 mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90 mg Only Ustekinumab 90mg to Golimumab
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/116 (12.93%)      4/26 (15.38%)      3/44 (6.82%)      0/43 (0.00%)      24/116 (20.69%)      7/21 (33.33%)      26/114 (22.81%)      4/14 (28.57%)    
Infections and infestations                 
Acute Sinusitis * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  1/114 (0.88%)  1/14 (7.14%) 
Influenza * 1 [1]  1/116 (0.86%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  2/116 (1.72%)  0/21 (0.00%)  0/114 (0.00%)  1/14 (7.14%) 
Respiratory Tract Infection Viral * 1 [1]  2/116 (1.72%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  6/114 (5.26%)  0/14 (0.00%) 
Upper Respiratory Tract Infection  1 [1]  2/116 (1.72%)  1/26 (3.85%)  0/44 (0.00%)  0/43 (0.00%)  3/116 (2.59%)  2/21 (9.52%)  4/114 (3.51%)  0/14 (0.00%) 
Viral Upper Respiratory Tract Infection * 1 [1]  5/116 (4.31%)  1/26 (3.85%)  1/44 (2.27%)  0/43 (0.00%)  9/116 (7.76%)  2/21 (9.52%)  11/114 (9.65%)  0/14 (0.00%) 
Investigations                 
Alanine Aminotransferase Increased * 1 [1]  6/116 (5.17%)  2/26 (7.69%)  1/44 (2.27%)  0/43 (0.00%)  8/116 (6.90%)  2/21 (9.52%)  6/114 (5.26%)  0/14 (0.00%) 
Aspartate Aminotransferase Increased * 1 [1]  3/116 (2.59%)  2/26 (7.69%)  0/44 (0.00%)  0/43 (0.00%)  8/116 (6.90%)  3/21 (14.29%)  3/114 (2.63%)  0/14 (0.00%) 
Metabolism and nutrition disorders                 
Hyperglycaemia * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  3/116 (2.59%)  0/21 (0.00%)  1/114 (0.88%)  1/14 (7.14%) 
Ankylosing Spondylitis * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  1/44 (2.27%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  1/14 (7.14%) 
Fasciitis * 1 [1]  0/116 (0.00%)  0/26 (0.00%)  0/44 (0.00%)  0/43 (0.00%)  0/116 (0.00%)  0/21 (0.00%)  0/114 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
[1]
MedDRA Version 20.0
Indicates events were collected by systematic assessment
The study was terminated since neither dose achieved the study's primary or major secondary endpoints.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: SENIOR DIRECTOR CLINICAL DEVELOPMENT
Organization: Johnson&Johnson
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02437162     History of Changes
Other Study ID Numbers: CR107098
CNTO1275AKS3001 ( Other Identifier: Janssen Research & Development, LLC )
2014-003679-48 ( EudraCT Number )
First Submitted: May 5, 2015
First Posted: May 7, 2015
Results First Submitted: March 22, 2018
Results First Posted: April 23, 2018
Last Update Posted: August 28, 2019