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Trial record 7 of 39 for:    "Spinal Disease" | "Benzocaine"

An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis

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ClinicalTrials.gov Identifier: NCT02407223
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 : April 2, 2015
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Nonradiographic Axial Spondylitis, Ankylosing
Interventions Drug: Group 1: Placebo
Drug: Group 2: Ustekinumab 45 mg
Drug: Group 3: Ustekinumab 90 mg
Enrollment 356
Recruitment Details  
Pre-assignment Details A total of 356 participants were randomized and received treatment (116 participants to placebo, 118 participants to ustekinumab 45 milligram [mg], and 122 participants to ustekinumab 90 mg).
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg
Hide Arm/Group Description Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100. Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] erythrocyte sedimentation rate [ESR] less than [<] 1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100. Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Period Title: Overall Study
Started 116 118 122
Early Escape at Week 16 22 [1] 0 0
Cross Over at Week 24 60 [1] 0 0
Qualified Re-randomization at Week 52 0 3 2
Completed 0 0 0
Not Completed 116 118 122
Reason Not Completed
Adverse Event             1             0             1
Lack of Efficacy             6             6             4
Lost to Follow-up             1             0             2
Withdrawal by Subject             2             4             4
Study Terminated by Sponsor             77             80             86
Subject Refused Further Study Treatment             0             1             0
Other             29             27             25
[1]
Study discontinuation/completion reported under randomization group
Arm/Group Title Placebo Ustekinumab 45mg Ustekinumab 90mg Total
Hide Arm/Group Description Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100. Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score [ASDAS] erythrocyte sedimentation rate [ESR] less than [<] 1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100. Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100. Total of all reporting groups
Overall Number of Baseline Participants 116 118 122 356
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 116 participants 118 participants 122 participants 356 participants
34  (8.75) 33.9  (8.39) 34.9  (9.06) 34.3  (8.73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 118 participants 122 participants 356 participants
Female
52
  44.8%
65
  55.1%
59
  48.4%
176
  49.4%
Male
64
  55.2%
53
  44.9%
63
  51.6%
180
  50.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 118 participants 122 participants 356 participants
Hispanic or Latino
10
   8.6%
14
  11.9%
13
  10.7%
37
  10.4%
Not Hispanic or Latino
105
  90.5%
104
  88.1%
109
  89.3%
318
  89.3%
Unknown or Not Reported
1
   0.9%
0
   0.0%
0
   0.0%
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 118 participants 122 participants 356 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
12
  10.3%
10
   8.5%
13
  10.7%
35
   9.8%
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%
3
   2.5%
0
   0.0%
3
   0.8%
White
98
  84.5%
99
  83.9%
104
  85.2%
301
  84.6%
More than one race
1
   0.9%
0
   0.0%
0
   0.0%
1
   0.3%
Unknown or Not Reported
5
   4.3%
6
   5.1%
5
   4.1%
16
   4.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 118 participants 122 participants 356 participants
Asian
12
  10.3%
10
   8.5%
13
  10.7%
35
   9.8%
Black or African American
0
   0.0%
3
   2.5%
0
   0.0%
3
   0.8%
Other
10
   8.6%
14
  11.9%
12
   9.8%
36
  10.1%
White Non-Hispanic
94
  81.0%
91
  77.1%
97
  79.5%
282
  79.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 116 participants 118 participants 122 participants 356 participants
ARGENTINA
2
   1.7%
0
   0.0%
4
   3.3%
6
   1.7%
AUSTRALIA
8
   6.9%
8
   6.8%
6
   4.9%
22
   6.2%
BELGIUM
8
   6.9%
10
   8.5%
9
   7.4%
27
   7.6%
CZECH REPUBLIC
11
   9.5%
8
   6.8%
8
   6.6%
27
   7.6%
FRANCE
6
   5.2%
5
   4.2%
3
   2.5%
14
   3.9%
GERMANY
2
   1.7%
9
   7.6%
7
   5.7%
18
   5.1%
HUNGARY
1
   0.9%
5
   4.2%
4
   3.3%
10
   2.8%
MEXICO
8
   6.9%
9
   7.6%
7
   5.7%
24
   6.7%
POLAND
18
  15.5%
11
   9.3%
16
  13.1%
45
  12.6%
RUSSIAN FEDERATION
18
  15.5%
22
  18.6%
22
  18.0%
62
  17.4%
SOUTH KOREA
6
   5.2%
1
   0.8%
5
   4.1%
12
   3.4%
TAIWAN
6
   5.2%
9
   7.6%
8
   6.6%
23
   6.5%
UKRAINE
18
  15.5%
19
  16.1%
20
  16.4%
57
  16.0%
UNITED KINGDOM
4
   3.4%
2
   1.7%
3
   2.5%
9
   2.5%
1.Primary Outcome
Title Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24
Hide Description ASAS 20 defined as improvement of greater than or equal to (>=) 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 centimeter(cm) scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 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 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;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 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 Full Analysis Set (MFAS)-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Measure Type: Number
Unit of Measure: Percentage of participants
47.6 55.4 49.4
2.Secondary Outcome
Title Percentage of Participants Who Achieved an ASAS 40 Response at Week 24
Hide Description ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor),total back pain (0 to 10 cm; 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 10 cm; 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
MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Measure Type: Number
Unit of Measure: Percentage of participants
25.6 33.7 28.2
3.Secondary Outcome
Title Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at 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. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness were 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. 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
MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Measure Type: Number
Unit of Measure: Percentage of participants
23.2 32.5 25.9
4.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) 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 ankylosing spondylitis 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
MFAS population was included. Participants were analyzed per assigned treatment regardless of actual treatment received. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 61 72 63
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.11  (2.371) -2.28  (2.625) -1.90  (2.731)
5.Secondary Outcome
Title Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (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 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*PGA)+ (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
MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Measure Type: Number
Unit of Measure: Percentage of participants
7.3 14.5 12.9
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 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). Here 'n' signifies the number of participants who were analyzed at each specified timepoints, for each arm, respectively.
Time Frame Baseline, Week 4, 8, 12, 16, 20 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
MFAS-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Mean (Standard Deviation)
Unit of Measure: Milligrams per deciliter (mg/dL)
Change at Week 4 Number Analyzed 82 participants 83 participants 84 participants
-0.08  (1.567) -0.10  (2.574) -0.39  (1.601)
Change at Week 8 Number Analyzed 82 participants 82 participants 82 participants
-0.23  (1.490) -0.53  (2.084) -0.57  (2.209)
Change at Week 12 Number Analyzed 80 participants 81 participants 81 participants
-0.23  (1.661) -0.71  (2.392) -0.61  (2.534)
Change at Week 16 Number Analyzed 79 participants 82 participants 80 participants
-0.49  (1.725) -0.63  (2.211) -0.61  (2.539)
Change at Week 20 Number Analyzed 61 participants 80 participants 80 participants
-0.36  (1.951) -0.78  (2.353) -0.76  (2.383)
Change at Week 24 Number Analyzed 62 participants 79 participants 79 participants
-0.42  (2.145) -0.63  (2.402) -0.78  (2.413)
7.Secondary Outcome
Title Percentage of Participants With ASAS 20 Components at Week 24
Hide Description ASAS 20 defined as >= 20% improvement from baseline in 4 individual components of ASAS20: Patient’s global assessment (PGA) of disease activity (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 to10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 relate to participant's ability to cope with life) and Inflammation (0 to 10cm;0=none,10=very severe).
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received. 'N' signifies number of participants who were evaluable for this endpoint.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 78 80 80
Measure Type: Number
Unit of Measure: Percentage of participants
>=20% improvement from baseline in PGA score 64.1 61.3 58.8
>=20% improvement from baseline in total back pain 62.8 60.0 60.0
>=20% improvement from baseline in BASFI 53.8 57.5 56.3
>=20% improvement from baseline in inflammation 64.1 66.3 65.0
8.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 of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (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
MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 3.7 8.4 11.8
Week 8 18.3 19.3 18.8
Week 12 17.1 27.7 24.7
Week 16 19.5 27.7 24.7
Week 20 24.4 38.6 32.9
9.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 of >= 20 % from baseline and 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 of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 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 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;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 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
MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 23.2 26.5 32.9
Week 8 31.7 41.0 36.5
Week 12 34.1 48.2 41.2
Week 16 40.2 49.4 35.3
Week 20 45.1 59.0 44.7
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 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. 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. 50% improvement 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 Week 4, 8, 12, 16, and 20
Hide Outcome Measure Data
Hide Analysis Population Description
MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 4.9 8.4 8.2
Week 8 9.8 15.7 17.6
Week 12 18.3 16.9 28.2
Week 16 19.5 21.7 24.7
Week 20 15.9 28.9 32.9
11.Secondary Outcome
Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (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. Missing data were imputed using early escape rule (measurement value at Week 20 and 24 was set as missing). Here 'n' defined as number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Time Frame Baseline, Week 4, 8, 12, 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
MFAS-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Change at Week 4 Number Analyzed 82 participants 83 participants 84 participants
-0.60  (1.582) -1.15  (1.748) -0.79  (1.600)
Change at Week 8 Number Analyzed 82 participants 82 participants 82 participants
-0.82  (1.997) -1.54  (2.177) -1.05  (2.095)
Change at Week 12 Number Analyzed 79 participants 82 participants 80 participants
-1.00  (2.064) -1.69  (2.079) -1.35  (2.458)
Change at Week 16 Number Analyzed 81 participants 82 participants 80 participants
-1.05  (2.162) -1.75  (2.312) -1.17  (2.747)
Change at Week 20 Number Analyzed 61 participants 80 participants 80 participants
-1.70  (2.339) -2.11  (2.394) -1.64  (2.794)
12.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 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*PGA)+ (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 4, 8, 12, 16, and 20
Hide Outcome Measure Data
Hide Analysis Population Description
MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.
Arm/Group Title Placebo Ustekinumab 45 mg Ustekinumab 90 mg
Hide Arm/Group Description:
Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS [ESR]<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Overall Number of Participants Analyzed 82 83 85
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 2.4 3.6 1.2
Week 8 6.1 7.2 9.4
Week 12 4.9 4.8 10.6
Week 16 6.1 7.2 11.8
Week 20 3.7 13.3 15.3
Time Frame Approximately up to 2.2 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. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
 
Arm/Group Title Placebo Only Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 90mg Only
Hide Arm/Group Description Participants received placebo SC at Week 0, 4, 16 and 20. At Week 16, participants in placebo group who qualified for EE criteria (with <10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16, 20 and 28 followed by q12w dosing through Week 52. Participants received placebo SC at Week 24 to maintain the blind. At Week 24, remaining participants in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Week 24 and 28 followed by q12w therapy through Week 52. At Week 52, participants who achieved inactive disease [ASDAS] [ESR]<1.3 at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned Ustekinumab dose at scheduled visits. Participants randomized to placebo SC at Week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 45 mg SC; adverse events are counted from crossover onward. All participants regardless qualified for re-randomization at Week 52 or not were counted. Participants randomized to placebo SC at week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 90 mg SC; adverse events are counted from crossover onward. All participants regardless qualified for re-randomization at Week 52 or not were counted. Participants received ustekinumab 45 mg subcutaneously (SC) at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All participants regardless qualified for re-randomization at Week 52 or not were counted. Participants received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.At Week 52, all participants who achieved inactive disease (ASDAS ESR<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All participants regardless qualified for re-randomization at Week 52 or not were counted.
All-Cause Mortality
Placebo Only Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 90mg Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/116 (0.00%)   0/42 (0.00%)   0/40 (0.00%)   0/118 (0.00%)   0/122 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Only Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 90mg Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/116 (1.72%)   0/42 (0.00%)   2/40 (5.00%)   2/118 (1.69%)   6/122 (4.92%) 
Eye disorders           
Uveitis * 1  1/116 (0.86%)  0/42 (0.00%)  0/40 (0.00%)  0/118 (0.00%)  0/122 (0.00%) 
Gastrointestinal disorders           
Inguinal Hernia * 1  0/116 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Infections and infestations           
Chronic Sinusitis * 1  0/116 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Gastroenteritis * 1  0/116 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Injury, poisoning and procedural complications           
Ankle Fracture * 1  0/116 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  1/118 (0.85%)  0/122 (0.00%) 
Musculoskeletal and connective tissue disorders           
Axial Spondyloarthritis * 1  1/116 (0.86%)  0/42 (0.00%)  0/40 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Spondyloarthropathy * 1  0/116 (0.00%)  0/42 (0.00%)  1/40 (2.50%)  0/118 (0.00%)  0/122 (0.00%) 
Psychiatric disorders           
Panic Attack * 1  0/116 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Renal and urinary disorders           
Nephrolithiasis * 1  0/116 (0.00%)  0/42 (0.00%)  1/40 (2.50%)  0/118 (0.00%)  0/122 (0.00%) 
Reproductive system and breast disorders           
Haemorrhagic Ovarian Cyst * 1  0/116 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
Menorrhagia * 1  0/116 (0.00%)  0/42 (0.00%)  0/40 (0.00%)  0/118 (0.00%)  1/122 (0.82%) 
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 Only Placebo to Ustekinumab 45mg Placebo to Ustekinumab 90mg Ustekinumab 45mg Only Ustekinumab 90mg Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/116 (16.38%)   4/42 (9.52%)   12/40 (30.00%)   27/118 (22.88%)   27/122 (22.13%) 
Gastrointestinal disorders           
Diarrhoea * 1  1/116 (0.86%)  1/42 (2.38%)  2/40 (5.00%)  2/118 (1.69%)  2/122 (1.64%) 
General disorders           
Fatigue * 1  2/116 (1.72%)  0/42 (0.00%)  4/40 (10.00%)  1/118 (0.85%)  2/122 (1.64%) 
Infections and infestations           
Sinusitis * 1  1/116 (0.86%)  1/42 (2.38%)  2/40 (5.00%)  0/118 (0.00%)  0/122 (0.00%) 
Upper Respiratory Tract Infection * 1  5/116 (4.31%)  2/42 (4.76%)  2/40 (5.00%)  5/118 (4.24%)  8/122 (6.56%) 
Viral Upper Respiratory Tract Infection * 1  6/116 (5.17%)  1/42 (2.38%)  1/40 (2.50%)  11/118 (9.32%)  9/122 (7.38%) 
Investigations           
Alanine Aminotransferase Increased * 1  3/116 (2.59%)  1/42 (2.38%)  2/40 (5.00%)  5/118 (4.24%)  4/122 (3.28%) 
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  2/116 (1.72%)  0/42 (0.00%)  2/40 (5.00%)  1/118 (0.85%)  3/122 (2.46%) 
Back Pain * 1  2/116 (1.72%)  1/42 (2.38%)  3/40 (7.50%)  2/118 (1.69%)  3/122 (2.46%) 
Nervous system disorders           
Headache * 1  1/116 (0.86%)  0/42 (0.00%)  2/40 (5.00%)  3/118 (2.54%)  4/122 (3.28%) 
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, therefore, the interpretation of the efficacy data is limited.
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: NCT02407223     History of Changes
Other Study ID Numbers: CR106995
CNTO1275AKS3003 ( Other Identifier: Janssen Research & Development, LLC )
2015-000289-67 ( EudraCT Number )
First Submitted: March 30, 2015
First Posted: April 2, 2015
Results First Submitted: September 26, 2018
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019