Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis (NCT NCT02438787)
NCT ID: NCT02438787
Last Updated: 2025-04-29
Results Overview
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).
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
315 participants
Primary outcome timeframe
Week(W) 24
Results posted on
2025-04-29
Participant Flow
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).
Participant milestones
| Measure |
Placebo
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.
|
Ustekinumab 45mg
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.
|
Ustekinumab 90mg
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 Study
STARTED
|
104
|
106
|
105
|
|
Overall Study
Early Escape at Week 16
|
21
|
21
|
20
|
|
Overall Study
Cross Over at Week 24
|
43
|
0
|
0
|
|
Overall Study
COMPLETED
|
23
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
81
|
83
|
83
|
Reasons for withdrawal
| Measure |
Placebo
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.
|
Ustekinumab 45mg
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.
|
Ustekinumab 90mg
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 Study
Adverse Event
|
1
|
0
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
15
|
7
|
10
|
|
Overall Study
Study discontinued by sponsor
|
64
|
72
|
69
|
|
Overall Study
Other
|
0
|
1
|
0
|
|
Overall Study
Site terminated by sponsor
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNF(Alpha) Refractory Participants With Active Radiographic Axial Spondyloarthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=104 Participants
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.
|
Ustekinumab 45mg
n=106 Participants
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.
|
Ustekinumab 90mg
n=105 Participants
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
n=315 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 11.33 • n=7 Participants
|
41.5 years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
41.2 years
STANDARD_DEVIATION 11.33 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
260 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
82 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
250 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
77 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
225 Participants
n=4 Participants
|
|
Region of Enrollment
ARGENTINA
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
BELGIUM
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
BRAZIL
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
BULGARIA
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
CANADA
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Region of Enrollment
FRANCE
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
GERMANY
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
HUNGARY
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
MEXICO
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
POLAND
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Region of Enrollment
PORTUGAL
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
19 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
|
Region of Enrollment
SOUTH KOREA
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Region of Enrollment
SPAIN
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
TAIWAN
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Region of Enrollment
UKRAINE
|
28 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Region of Enrollment
UNITED STATES
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week(W) 24Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an Assessment of SpondyloArthritis International Society (ASAS) 40 Response at Week 24
|
12.3 Percentage of participants
|
19.2 Percentage of participants
|
26.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved an ASAS 20 Response at Week 24
|
27.4 Percentage of participants
|
31.5 Percentage of participants
|
37.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24
|
11.0 Percentage of participants
|
15.1 Percentage of participants
|
28.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=44 Participants
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.
|
Ustekinumab 45mg
n=44 Participants
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.
|
Ustekinumab 90mg
n=42 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24
|
-1.29 Units on a scale
Standard Deviation 2.219
|
-1.74 Units on a scale
Standard Deviation 2.724
|
-2.17 Units on a scale
Standard Deviation 2.438
|
SECONDARY outcome
Timeframe: Week 24Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24
|
0 Percentage of participants
|
2.7 Percentage of participants
|
3.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16, 20 and 24Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change at Week 4
|
0.12 Milligrams per deciliter (mg/dL)
Standard Deviation 2.211
|
-0.35 Milligrams per deciliter (mg/dL)
Standard Deviation 2.171
|
-0.12 Milligrams per deciliter (mg/dL)
Standard Deviation 1.604
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change at Week 8
|
-0.18 Milligrams per deciliter (mg/dL)
Standard Deviation 2.526
|
-0.54 Milligrams per deciliter (mg/dL)
Standard Deviation 2.213
|
-0.24 Milligrams per deciliter (mg/dL)
Standard Deviation 2.555
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change at Week 12
|
-0.02 Milligrams per deciliter (mg/dL)
Standard Deviation 2.836
|
-0.36 Milligrams per deciliter (mg/dL)
Standard Deviation 2.495
|
0.05 Milligrams per deciliter (mg/dL)
Standard Deviation 2.842
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change at Week 16
|
-0.06 Milligrams per deciliter (mg/dL)
Standard Deviation 2.676
|
-0.21 Milligrams per deciliter (mg/dL)
Standard Deviation 2.333
|
0.12 Milligrams per deciliter (mg/dL)
Standard Deviation 2.720
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change at Week 20
|
0.23 Milligrams per deciliter (mg/dL)
Standard Deviation 2.266
|
-0.11 Milligrams per deciliter (mg/dL)
Standard Deviation 1.611
|
-0.40 Milligrams per deciliter (mg/dL)
Standard Deviation 2.198
|
|
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24
Change at Week 24
|
-0.36 Milligrams per deciliter (mg/dL)
Standard Deviation 2.067
|
-0.14 Milligrams per deciliter (mg/dL)
Standard Deviation 2.041
|
-0.26 Milligrams per deciliter (mg/dL)
Standard Deviation 1.850
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16 and 20Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
Week 4
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
Week 8
|
0 Percentage of participants
|
2.7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
Week 12
|
0 Percentage of participants
|
1.4 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
Week 16
|
0 Percentage of participants
|
1.4 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20
Week 20
|
1.4 Percentage of participants
|
1.4 Percentage of participants
|
1.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16 and 20Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
Week 4
|
6.8 Percentage of participants
|
8.2 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
Week 8
|
11.0 Percentage of participants
|
12.3 Percentage of participants
|
16.4 Percentage of participants
|
|
Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
Week 12
|
6.8 Percentage of participants
|
15.1 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
Week 16
|
9.6 Percentage of participants
|
15.1 Percentage of participants
|
20.9 Percentage of participants
|
|
Percentage of Participants Who Achieved ASAS 40 Responses at Week 4, 8, 12, 16 and 20
Week 20
|
12.3 Percentage of participants
|
21.9 Percentage of participants
|
25.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16 and 20Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
Week 4
|
19.2 Percentage of participants
|
26.0 Percentage of participants
|
31.3 Percentage of participants
|
|
Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
Week 8
|
20.5 Percentage of participants
|
34.2 Percentage of participants
|
29.9 Percentage of participants
|
|
Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
Week 12
|
24.7 Percentage of participants
|
30.1 Percentage of participants
|
32.8 Percentage of participants
|
|
Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
Week 16
|
23.3 Percentage of participants
|
21.9 Percentage of participants
|
35.8 Percentage of participants
|
|
Percentage of Participants Who Achieved ASAS 20 Responses at Week 4, 8, 12, 16 and 20
Week 20
|
28.8 Percentage of participants
|
35.6 Percentage of participants
|
41.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4, 8, 12, 16 and 20Population: Modified-FAS population was used. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
Week 4
|
5.5 Percentage of participants
|
6.8 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
Week 8
|
8.2 Percentage of participants
|
11.0 Percentage of participants
|
13.4 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
Week 12
|
4.1 Percentage of participants
|
15.1 Percentage of participants
|
11.9 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
Week 16
|
11.0 Percentage of participants
|
15.1 Percentage of participants
|
16.4 Percentage of participants
|
|
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20
Week 20
|
8.2 Percentage of participants
|
16.4 Percentage of participants
|
19.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4, 8, 12, 16 and 20Population: 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.
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).
Outcome measures
| Measure |
Placebo
n=73 Participants
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.
|
Ustekinumab 45mg
n=73 Participants
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.
|
Ustekinumab 90mg
n=67 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20
Change at Week 4
|
-0.58 Units on a scale
Standard Deviation 1.571
|
-0.69 Units on a scale
Standard Deviation 1.662
|
-0.73 Units on a scale
Standard Deviation 1.915
|
|
Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20
Change at Week 8
|
-0.66 Units on a scale
Standard Deviation 2.099
|
-0.86 Units on a scale
Standard Deviation 2.010
|
-1.02 Units on a scale
Standard Deviation 2.010
|
|
Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20
Change at Week 12
|
-0.73 Units on a scale
Standard Deviation 2.406
|
-0.70 Units on a scale
Standard Deviation 2.380
|
-0.77 Units on a scale
Standard Deviation 2.459
|
|
Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20
Change at Week 16
|
-0.58 Units on a scale
Standard Deviation 2.053
|
-0.54 Units on a scale
Standard Deviation 2.491
|
-0.80 Units on a scale
Standard Deviation 2.574
|
|
Change From Baseline in BASFI Total Score at Week 4, 8, 12, 16 and 20
Change at Week 20
|
-1.45 Units on a scale
Standard Deviation 2.353
|
-1.73 Units on a scale
Standard Deviation 2.564
|
-2.16 Units on a scale
Standard Deviation 2.140
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo to Golimumab
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo to Ustekinumab 45mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo to Ustekinumab 90mg
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Ustekinumab 45mg Only
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Ustekinumab 45mg to Golimumab
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Ustekinumab 90mg Only
Serious events: 6 serious events
Other events: 18 other events
Deaths: 0 deaths
Ustekinumab 90mg to Golimumab
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=104 participants at risk
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.
|
Placebo to Golimumab
n=21 participants at risk
Participants randomized to placebo SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
|
Placebo to Ustekinumab 45mg
n=21 participants at risk
Participants randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward.
|
Placebo to Ustekinumab 90mg
n=22 participants at risk
Participants randomized to placebo SC and then rerandomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward.
|
Ustekinumab 45mg Only
n=106 participants at risk
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.
|
Ustekinumab 45mg to Golimumab
n=21 participants at risk
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.
|
Ustekinumab 90mg Only
n=105 participants at risk
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.
|
Ustekinumab 90mg to Golimumab
n=20 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/104 • Up to Week 64
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.
|
4.8%
1/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Eye disorders
Iritis
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Musculoskeletal and connective tissue disorders
Axial Spondyloarthritis
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
1.9%
2/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/104 • Up to Week 64
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.
|
4.8%
1/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
4.8%
1/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Renal and urinary disorders
Renal Amyloidosis
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
4.5%
1/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.96%
1/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
Other adverse events
| Measure |
Placebo
n=104 participants at risk
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.
|
Placebo to Golimumab
n=21 participants at risk
Participants randomized to placebo SC who met early escape criteria and received golimumab from Week 16; adverse events are counted from early escape onward.
|
Placebo to Ustekinumab 45mg
n=21 participants at risk
Participants randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward.
|
Placebo to Ustekinumab 90mg
n=22 participants at risk
Participants randomized to placebo SC and then rerandomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward.
|
Ustekinumab 45mg Only
n=106 participants at risk
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.
|
Ustekinumab 45mg to Golimumab
n=21 participants at risk
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.
|
Ustekinumab 90mg Only
n=105 participants at risk
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.
|
Ustekinumab 90mg to Golimumab
n=20 participants at risk
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.
|
|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Insomnia
|
0.96%
1/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.96%
1/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
3.8%
4/106 • Up to Week 64
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.
|
4.8%
1/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
5/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
9.5%
2/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
0.00%
0/20 • Up to Week 64
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.
|
|
General disorders
Injection Site Bruising
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
1.9%
2/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Infections and infestations
Pharyngitis
|
1.9%
2/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
2.8%
3/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
4.8%
1/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Infections and infestations
Viral Infection
|
0.96%
1/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
1.9%
2/106 • Up to Week 64
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.
|
4.8%
1/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
3.8%
4/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
3.8%
4/106 • Up to Week 64
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.
|
9.5%
2/21 • Up to Week 64
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.
|
7.6%
8/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.8%
6/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
4.5%
1/22 • Up to Week 64
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.
|
1.9%
2/106 • Up to Week 64
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.
|
9.5%
2/21 • Up to Week 64
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.
|
3.8%
4/105 • Up to Week 64
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.
|
10.0%
2/20 • Up to Week 64
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.
|
|
Investigations
Aspartate Aminotransferase Increased
|
4.8%
5/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
4.5%
1/22 • Up to Week 64
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.
|
1.9%
2/106 • Up to Week 64
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.
|
9.5%
2/21 • Up to Week 64
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.
|
2.9%
3/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.00%
0/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.95%
1/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.96%
1/104 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/22 • Up to Week 64
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.
|
0.94%
1/106 • Up to Week 64
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.
|
0.00%
0/21 • Up to Week 64
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.
|
0.00%
0/105 • Up to Week 64
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.
|
5.0%
1/20 • Up to Week 64
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.
|
Additional Information
Scientific Director
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER