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Trial record 22 of 39 for:    "Spinal Disease" | "Benzocaine"

A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438787
Recruitment Status : Terminated (This study was stopped because ustekinumab did not achieve key endpoints in a related study. The safety profile was consistent with past ustekinumab studies.)
First Posted : May 8, 2015
Results First Posted : October 1, 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 315
Recruitment Details  
Pre-assignment Details A total of 315 participants were randomized and treated (104 participants to placebo, 106 participants to ustekinumab 45 milligram (mg), and 105 participants to 90 mg).
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met early escape (EE) criteria were administered open-label golimumab 50 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 EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52. Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind. Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Period Title: Overall Study
Started 104 106 105
Early Escape at Week 16 21 [1] 21 [1] 20 [1]
Cross Over at Week 24 43 [2] 0 0
Completed 23 23 22
Not Completed 81 83 83
Reason Not Completed
Adverse Event             1             0             2
Lack of Efficacy             1             2             0
Lost to Follow-up             0             1             0
Protocol Violation             0             0             1
Withdrawal by Subject             15             7             10
Study discontinued by sponsor             64             72             69
Other             0             1             0
Site terminated by sponsor             0             0             1
[1]
Study discontinuation/completion reported under randomization group
[2]
Out of 43: crossed over to Ustekinumab 45 mg (n=21) and Ustekinumab 90 mg (n=22)
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg Total
Hide Arm/Group Description Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52. Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind. Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind. Total of all reporting groups
Overall Number of Baseline Participants 104 106 105 315
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) includes 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 104 participants 106 participants 105 participants 315 participants
40.8  (11.72) 41.4  (11.33) 41.5  (11.02) 41.2  (11.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 105 participants 315 participants
Female
24
  23.1%
18
  17.0%
13
  12.4%
55
  17.5%
Male
80
  76.9%
88
  83.0%
92
  87.6%
260
  82.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 105 participants 315 participants
Hispanic or Latino
12
  11.5%
14
  13.2%
16
  15.2%
42
  13.3%
Not Hispanic or Latino
91
  87.5%
91
  85.8%
88
  83.8%
270
  85.7%
Unknown or Not Reported
1
   1.0%
1
   0.9%
1
   1.0%
3
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 105 participants 315 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
14
  13.5%
16
  15.1%
14
  13.3%
44
  14.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.0%
1
   0.9%
0
   0.0%
2
   0.6%
White
82
  78.8%
84
  79.2%
84
  80.0%
250
  79.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
7
   6.7%
5
   4.7%
7
   6.7%
19
   6.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 105 participants 315 participants
Asian
14
  13.5%
16
  15.1%
14
  13.3%
44
  14.0%
Black or African American
1
   1.0%
1
   0.9%
0
   0.0%
2
   0.6%
Hispanic or Latino
4
   3.8%
8
   7.5%
10
   9.5%
22
   7.0%
Other
8
   7.7%
6
   5.7%
8
   7.6%
22
   7.0%
White Non-Hispanic
77
  74.0%
75
  70.8%
73
  69.5%
225
  71.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 105 participants 315 participants
ARGENTINA
2
   1.9%
3
   2.8%
2
   1.9%
7
   2.2%
BELGIUM
3
   2.9%
1
   0.9%
1
   1.0%
5
   1.6%
BRAZIL
3
   2.9%
2
   1.9%
5
   4.8%
10
   3.2%
BULGARIA
5
   4.8%
3
   2.8%
5
   4.8%
13
   4.1%
CANADA
1
   1.0%
0
   0.0%
1
   1.0%
2
   0.6%
CZECH REPUBLIC
1
   1.0%
1
   0.9%
1
   1.0%
3
   1.0%
FRANCE
0
   0.0%
1
   0.9%
1
   1.0%
2
   0.6%
GERMANY
2
   1.9%
4
   3.8%
3
   2.9%
9
   2.9%
HUNGARY
4
   3.8%
9
   8.5%
6
   5.7%
19
   6.0%
MEXICO
8
   7.7%
7
   6.6%
7
   6.7%
22
   7.0%
POLAND
5
   4.8%
5
   4.7%
5
   4.8%
15
   4.8%
PORTUGAL
1
   1.0%
0
   0.0%
0
   0.0%
1
   0.3%
RUSSIAN FEDERATION
19
  18.3%
27
  25.5%
23
  21.9%
69
  21.9%
SOUTH KOREA
6
   5.8%
5
   4.7%
3
   2.9%
14
   4.4%
SPAIN
3
   2.9%
4
   3.8%
4
   3.8%
11
   3.5%
TAIWAN
8
   7.7%
10
   9.4%
11
  10.5%
29
   9.2%
UKRAINE
28
  26.9%
16
  15.1%
22
  21.0%
66
  21.0%
UNITED KINGDOM
3
   2.9%
4
   3.8%
3
   2.9%
10
   3.2%
UNITED STATES
2
   1.9%
4
   3.8%
2
   1.9%
8
   2.5%
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% 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(non responder imputation)] (missing responses at post baseline visit imputed as non-responder).
Time Frame Week(W) 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified-FAS included FAS population, excluding who discontinued study agent prior to W24 due to trial termination,not had efficacy assessments at W24,but not excluding participants who met EE at W16/ had treatment failure prior to W24.Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Measure Type: Number
Unit of Measure: Percentage of participants
12.3 19.2 26.9
2.Secondary Outcome
Title Percentage of Participants Who Achieved an ASAS 20 Response at Week 24
Hide Description ASAS 20 defined as improvement from baseline of >= 20% from baseline 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 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 (>= 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Measure Type: Number
Unit of Measure: Percentage of participants
27.4 31.5 37.3
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 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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS 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. 50% improvement in 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
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Measure Type: Number
Unit of Measure: Percentage of participants
11.0 15.1 28.4
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. Missing data were imputed using early escape rule (consider non-responder at Week 20 and 24).
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified-FAS population was used. 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 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 44 44 42
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.29  (2.219) -1.74  (2.724) -2.17  (2.438)
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 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-responder).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Measure Type: Number
Unit of Measure: Percentage of participants
0 2.7 3.0
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 was 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
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants analyzed for this endpoint at specific timepoints.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Mean (Standard Deviation)
Unit of Measure: Milligrams per deciliter (mg/dL)
Change at Week 4 Number Analyzed 71 participants 69 participants 67 participants
0.12  (2.211) -0.35  (2.171) -0.12  (1.604)
Change at Week 8 Number Analyzed 69 participants 68 participants 65 participants
-0.18  (2.526) -0.54  (2.213) -0.24  (2.555)
Change at Week 12 Number Analyzed 68 participants 68 participants 64 participants
-0.02  (2.836) -0.36  (2.495) 0.05  (2.842)
Change at Week 16 Number Analyzed 66 participants 67 participants 64 participants
-0.06  (2.676) -0.21  (2.333) 0.12  (2.720)
Change at Week 20 Number Analyzed 42 participants 45 participants 44 participants
0.23  (2.266) -0.11  (1.611) -0.40  (2.198)
Change at Week 24 Number Analyzed 43 participants 44 participants 43 participants
-0.36  (2.067) -0.14  (2.041) -0.26  (1.850)
7.Secondary Outcome
Title Percentage of Participants With 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
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 0 0 0
Week 8 0 2.7 0
Week 12 0 1.4 3.0
Week 16 0 1.4 3.0
Week 20 1.4 1.4 1.5
8.Secondary Outcome
Title Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
Hide Description ASAS 40 defined as improvement from baseline >= 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
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 6.8 8.2 11.9
Week 8 11.0 12.3 16.4
Week 12 6.8 15.1 19.4
Week 16 9.6 15.1 20.9
Week 20 12.3 21.9 25.4
9.Secondary Outcome
Title Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
Hide Description ASAS 20 defined as improvement from baseline of >= 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 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 (>= 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
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 19.2 26.0 31.3
Week 8 20.5 34.2 29.9
Week 12 24.7 30.1 32.8
Week 16 23.3 21.9 35.8
Week 20 28.8 35.6 41.8
10.Secondary Outcome
Title Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
Hide Description 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), morning stiffness(MS) (2 questions: duration and severity). Each question is an easy to answer 10 cm visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question related to MS duration: 0(0 hours), 10(2 or more hours). In order to give each of 5 symptoms equal weight, mean of 2 questions about MS 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. 50% improvement in 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
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 5.5 6.8 11.9
Week 8 8.2 11.0 13.4
Week 12 4.1 15.1 11.9
Week 16 11.0 15.1 16.4
Week 20 8.2 16.4 19.4
11.Secondary Outcome
Title Change From Baseline in BASFI Total Score 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. Missing data were imputed using early escape rule (consider non-responder at Week 20 and 24).
Time Frame Baseline, Week 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' (number analyzed) signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description:
Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52.
Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Participants received Ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52. 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 were to receive placebo SC injection to maintain the blind.
Overall Number of Participants Analyzed 73 73 67
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 71 participants 69 participants 66 participants
-0.58  (1.571) -0.69  (1.662) -0.73  (1.915)
Change at Week 8 Number Analyzed 69 participants 68 participants 64 participants
-0.66  (2.099) -0.86  (2.010) -1.02  (2.010)
Change at Week 12 Number Analyzed 68 participants 68 participants 63 participants
-0.73  (2.406) -0.70  (2.380) -0.77  (2.459)
Change at Week 16 Number Analyzed 66 participants 67 participants 63 participants
-0.58  (2.053) -0.54  (2.491) -0.80  (2.574)
Change at Week 20 Number Analyzed 41 participants 45 participants 43 participants
-1.45  (2.353) -1.73  (2.564) -2.16  (2.140)
Time Frame Up to Week 64
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 Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90mg Only Ustekinumab 90mg to Golimumab
Hide Arm/Group Description Participants received placebo SC injection at Weeks 0, 4, and 16. 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 all participants (with the exception of participants who qualified for EE) were re-randomized to receive either ustekinumab 45 or 90 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing. Included all participants, but adverse events for participants who early escaped at Week 16 or crossed over at Week 24 are only counted up to Week 16 or Week 24 respectively. Participants randomized to placebo SC who met early escape criteria and received golimumab 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 q12w dosing. Adverse events for participants who early escaped at Week 16 are only counted up to Week 16. Participants randomized to ustekinumab 45 mg SC who met early escape criteria and received golimumab 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. Adverse events for participants who early escaped at Week 16 are only counted up to Week 16. Participants randomized to ustekinumab 90 mg SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
All-Cause Mortality
Placebo Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90mg 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   0/104 (0.00%)   0/21 (0.00%)   0/21 (0.00%)   0/22 (0.00%)   0/106 (0.00%)   0/21 (0.00%)   0/105 (0.00%)   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90mg 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   1/104 (0.96%)   2/21 (9.52%)   0/21 (0.00%)   1/22 (4.55%)   3/106 (2.83%)   1/21 (4.76%)   6/105 (5.71%)   1/20 (5.00%) 
Cardiac disorders                 
Myocardial Ischaemia * 1  0/104 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Eye disorders                 
Iritis * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders                 
Abdominal Pain Upper * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Gastrointestinal Haemorrhage * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  1/105 (0.95%)  0/20 (0.00%) 
Nausea * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Vomiting * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Hepatobiliary disorders                 
Cholelithiasis * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  1/105 (0.95%)  0/20 (0.00%) 
Metabolism and nutrition disorders                 
Obesity * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Axial Spondyloarthritis * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  2/105 (1.90%)  0/20 (0.00%) 
Back Pain * 1  0/104 (0.00%)  1/21 (4.76%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Rotator Cuff Syndrome * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  1/105 (0.95%)  0/20 (0.00%) 
Nervous system disorders                 
Cerebrovascular Accident * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  1/105 (0.95%)  0/20 (0.00%) 
Renal and urinary disorders                 
Nephrolithiasis * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  1/21 (4.76%)  0/105 (0.00%)  0/20 (0.00%) 
Renal Amyloidosis * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Reproductive system and breast disorders                 
Uterine Polyp * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Uterine Prolapse * 1  1/104 (0.96%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Chronic Obstructive Pulmonary Disease * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Placebo to Golimumab Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 45mg to Golimumab Ustekinumab 90mg 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   19/104 (18.27%)   0/21 (0.00%)   2/21 (9.52%)   1/22 (4.55%)   19/106 (17.92%)   7/21 (33.33%)   18/105 (17.14%)   10/20 (50.00%) 
Blood and lymphatic system disorders                 
Neutropenia * 1  1/104 (0.96%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  4/106 (3.77%)  1/21 (4.76%)  1/105 (0.95%)  1/20 (5.00%) 
Eye disorders                 
Vitreous Haemorrhage * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
Gastrointestinal disorders                 
Diarrhoea * 1  5/104 (4.81%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
Dyspepsia * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
Mouth Ulceration * 1  0/104 (0.00%)  0/21 (0.00%)  2/21 (9.52%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  0/20 (0.00%) 
General disorders                 
Injection Site Bruising * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
Immune system disorders                 
Hypersensitivity * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
Infections and infestations                 
Bronchitis * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  2/106 (1.89%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
Pharyngitis * 1  2/104 (1.92%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  3/106 (2.83%)  0/21 (0.00%)  1/105 (0.95%)  1/20 (5.00%) 
Respiratory Tract Infection * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  1/21 (4.76%)  1/105 (0.95%)  1/20 (5.00%) 
Viral Infection * 1  1/104 (0.96%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  2/106 (1.89%)  1/21 (4.76%)  1/105 (0.95%)  1/20 (5.00%) 
Viral Upper Respiratory Tract Infection * 1  4/104 (3.85%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  4/106 (3.77%)  2/21 (9.52%)  8/105 (7.62%)  1/20 (5.00%) 
Injury, poisoning and procedural complications                 
Ligament Sprain * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  1/105 (0.95%)  1/20 (5.00%) 
Investigations                 
Alanine Aminotransferase Increased * 1  6/104 (5.77%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  2/106 (1.89%)  2/21 (9.52%)  4/105 (3.81%)  2/20 (10.00%) 
Aspartate Aminotransferase Increased * 1  5/104 (4.81%)  0/21 (0.00%)  0/21 (0.00%)  1/22 (4.55%)  2/106 (1.89%)  2/21 (9.52%)  3/105 (2.86%)  1/20 (5.00%) 
Metabolism and nutrition disorders                 
Gout * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  1/105 (0.95%)  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders                 
Spondylitis * 1  1/104 (0.96%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
Psychiatric disorders                 
Insomnia * 1  1/104 (0.96%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  1/106 (0.94%)  0/21 (0.00%)  1/105 (0.95%)  1/20 (5.00%) 
Skin and subcutaneous tissue disorders                 
Skin Disorder * 1  0/104 (0.00%)  0/21 (0.00%)  0/21 (0.00%)  0/22 (0.00%)  0/106 (0.00%)  0/21 (0.00%)  0/105 (0.00%)  1/20 (5.00%) 
1
Term from vocabulary, MedDRA Version 20.0
*
Indicates events were collected by non-systematic assessment
The study was discontinued before it was fully enrolled due to lack of efficacy of either dose of ustekinumab in the CNTO1275AKS3001 (NCT02437162) study.
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: Scientific Director
Organization: Janssen Research & Development, LLC
Phone: 844-434-4210
EMail: ClinicalTrialDisclosure@its.jnj.com
Layout table for additonal information
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02438787     History of Changes
Other Study ID Numbers: CR107099
CNTO1275AKS3002 ( Other Identifier: Janssen Research & Development, LLC )
2015-000288-16 ( EudraCT Number )
First Submitted: May 6, 2015
First Posted: May 8, 2015
Results First Submitted: August 30, 2018
Results First Posted: October 1, 2018
Last Update Posted: August 28, 2019