Trial Outcomes & Findings for An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis (NCT NCT02407223)

Last Updated: 2019-03-13

Results Overview

ASAS 20 defined as improvement of greater than or equal to (\>=) 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 centimeter(cm) scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (\>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

356 participants

Primary outcome timeframe

Week 24

Results posted on

2019-03-13

Participant Flow

A total of 356 participants were randomized and received treatment (116 participants to placebo, 118 participants to ustekinumab 45 milligram \[mg\], and 122 participants to ustekinumab 90 mg).

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45mg Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score \[ASDAS\] erythrocyte sedimentation rate \[ESR\] less than \[\<\] 1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 90mg Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR\<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Overall Study STARTED	116	118	122
Overall Study Early Escape at Week 16	22	0	0
Overall Study Cross Over at Week 24	60	0	0
Overall Study Qualified Re-randomization at Week 52	0	3	2
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	116	118	122

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45mg Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score \[ASDAS\] erythrocyte sedimentation rate \[ESR\] less than \[\<\] 1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 90mg Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR\<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.
Overall Study Adverse Event	1	0	1
Overall Study Lack of Efficacy	6	6	4
Overall Study Lost to Follow-up	1	0	2
Overall Study Withdrawal by Subject	2	4	4
Overall Study Study Terminated by Sponsor	77	80	86
Overall Study Subject Refused Further Study Treatment	0	1	0
Overall Study Other	29	27	25

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45mg n=118 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (Ankylosing Spondylitis Disease Activity Score \[ASDAS\] erythrocyte sedimentation rate \[ESR\] less than \[\<\] 1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 90mg n=122 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR\<1.3) at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Total n=356 Participants Total of all reporting groups
Age, Continuous	34 years STANDARD_DEVIATION 8.75 • n=5 Participants	33.9 years STANDARD_DEVIATION 8.39 • n=7 Participants	34.9 years STANDARD_DEVIATION 9.06 • n=5 Participants	34.3 years STANDARD_DEVIATION 8.73 • n=4 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	65 Participants n=7 Participants	59 Participants n=5 Participants	176 Participants n=4 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	53 Participants n=7 Participants	63 Participants n=5 Participants	180 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	105 Participants n=5 Participants	104 Participants n=7 Participants	109 Participants n=5 Participants	318 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 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	12 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	35 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	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	98 Participants n=5 Participants	99 Participants n=7 Participants	104 Participants n=5 Participants	301 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Asian	12 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants	35 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Other	10 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Race/Ethnicity, Customized White Non-Hispanic	94 Participants n=5 Participants	91 Participants n=7 Participants	97 Participants n=5 Participants	282 Participants n=4 Participants
Region of Enrollment ARGENTINA	2 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants
Region of Enrollment AUSTRALIA	8 Participants n=5 Participants	8 Participants n=7 Participants	6 Participants n=5 Participants	22 Participants n=4 Participants
Region of Enrollment BELGIUM	8 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment CZECH REPUBLIC	11 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	27 Participants n=4 Participants
Region of Enrollment FRANCE	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Region of Enrollment GERMANY	2 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Region of Enrollment HUNGARY	1 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Region of Enrollment MEXICO	8 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	24 Participants n=4 Participants
Region of Enrollment POLAND	18 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants	45 Participants n=4 Participants
Region of Enrollment RUSSIAN FEDERATION	18 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	62 Participants n=4 Participants
Region of Enrollment SOUTH KOREA	6 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Region of Enrollment TAIWAN	6 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Region of Enrollment UKRAINE	18 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	57 Participants n=4 Participants
Region of Enrollment UNITED KINGDOM	4 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: Modified Full Analysis Set (MFAS)-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24	47.6 Percentage of participants	55.4 Percentage of participants	49.4 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: MFAS- participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.

ASAS 40 defined as improvement of \>= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor),total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants Who Achieved an ASAS 40 Response at Week 24	25.6 Percentage of participants	33.7 Percentage of participants	28.2 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness were added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24	23.2 Percentage of participants	32.5 Percentage of participants	25.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: MFAS population was included. Participants were analyzed per assigned treatment regardless of actual treatment received. 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.

The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of ankylosing spondylitis participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=72 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=63 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24	-2.11 Units on a scale Standard Deviation 2.371	-2.28 Units on a scale Standard Deviation 2.625	-1.90 Units on a scale Standard Deviation 2.731

SECONDARY outcome

Timeframe: Week 24

ASDAS includes CRP milligram per liter (mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*total back pain)+ (0.110\*PGA)+ (0.073\*peripheral pain/swelling)+ (0.058\* DMS)+ (0.579\*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =\>2 hours). Inactive disease is defined as an ASDAS score \<1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24	7.3 Percentage of participants	14.5 Percentage of participants	12.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 12, 16, 20 and 24

Population: MFAS-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.

Change from baseline in hsCRP levels was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). Here 'n' signifies the number of participants who were analyzed at each specified timepoints, for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 4	-0.08 Milligrams per deciliter (mg/dL) Standard Deviation 1.567	-0.10 Milligrams per deciliter (mg/dL) Standard Deviation 2.574	-0.39 Milligrams per deciliter (mg/dL) Standard Deviation 1.601
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 8	-0.23 Milligrams per deciliter (mg/dL) Standard Deviation 1.490	-0.53 Milligrams per deciliter (mg/dL) Standard Deviation 2.084	-0.57 Milligrams per deciliter (mg/dL) Standard Deviation 2.209
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 12	-0.23 Milligrams per deciliter (mg/dL) Standard Deviation 1.661	-0.71 Milligrams per deciliter (mg/dL) Standard Deviation 2.392	-0.61 Milligrams per deciliter (mg/dL) Standard Deviation 2.534
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 16	-0.49 Milligrams per deciliter (mg/dL) Standard Deviation 1.725	-0.63 Milligrams per deciliter (mg/dL) Standard Deviation 2.211	-0.61 Milligrams per deciliter (mg/dL) Standard Deviation 2.539
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 20	-0.36 Milligrams per deciliter (mg/dL) Standard Deviation 1.951	-0.78 Milligrams per deciliter (mg/dL) Standard Deviation 2.353	-0.76 Milligrams per deciliter (mg/dL) Standard Deviation 2.383
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 24	-0.42 Milligrams per deciliter (mg/dL) Standard Deviation 2.145	-0.63 Milligrams per deciliter (mg/dL) Standard Deviation 2.402	-0.78 Milligrams per deciliter (mg/dL) Standard Deviation 2.413

SECONDARY outcome

Timeframe: Week 24

ASAS 20 defined as \>= 20% improvement from baseline in 4 individual components of ASAS20: Patient's global assessment (PGA) of disease activity (0 to 10cm; 0=very well,10=very poor), total back pain(0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean(0 to10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 relate to participant's ability to cope with life) and Inflammation (0 to 10cm;0=none,10=very severe).

Outcome measures

Outcome measures
Measure	Placebo n=78 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=80 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=80 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants With ASAS 20 Components at Week 24 >=20% improvement from baseline in PGA score	64.1 Percentage of participants	61.3 Percentage of participants	58.8 Percentage of participants
Percentage of Participants With ASAS 20 Components at Week 24 >=20% improvement from baseline in total back pain	62.8 Percentage of participants	60.0 Percentage of participants	60.0 Percentage of participants
Percentage of Participants With ASAS 20 Components at Week 24 >=20% improvement from baseline in BASFI	53.8 Percentage of participants	57.5 Percentage of participants	56.3 Percentage of participants
Percentage of Participants With ASAS 20 Components at Week 24 >=20% improvement from baseline in inflammation	64.1 Percentage of participants	66.3 Percentage of participants	65.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 4, 8, 12, 16 and 20

ASAS 40 defined as improvement of \>= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure (consider non-responders at and after treatment failure), early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 4	3.7 Percentage of participants	8.4 Percentage of participants	11.8 Percentage of participants
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 8	18.3 Percentage of participants	19.3 Percentage of participants	18.8 Percentage of participants
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 12	17.1 Percentage of participants	27.7 Percentage of participants	24.7 Percentage of participants
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 16	19.5 Percentage of participants	27.7 Percentage of participants	24.7 Percentage of participants
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 20	24.4 Percentage of participants	38.6 Percentage of participants	32.9 Percentage of participants

SECONDARY outcome

Timeframe: Week 4, 8, 12, 16 and 20

ASAS 20 defined as improvement of \>= 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (\>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 12	34.1 Percentage of participants	48.2 Percentage of participants	41.2 Percentage of participants
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 4	23.2 Percentage of participants	26.5 Percentage of participants	32.9 Percentage of participants
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 8	31.7 Percentage of participants	41.0 Percentage of participants	36.5 Percentage of participants
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 16	40.2 Percentage of participants	49.4 Percentage of participants	35.3 Percentage of participants
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 20	45.1 Percentage of participants	59.0 Percentage of participants	44.7 Percentage of participants

SECONDARY outcome

Timeframe: Week 4, 8, 12, 16, and 20

The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 Week 4	4.9 Percentage of participants	8.4 Percentage of participants	8.2 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	9.8 Percentage of participants	15.7 Percentage of participants	17.6 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	18.3 Percentage of participants	16.9 Percentage of participants	28.2 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	19.5 Percentage of participants	21.7 Percentage of participants	24.7 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	15.9 Percentage of participants	28.9 Percentage of participants	32.9 Percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4, 8, 12, 16 and 20

Population: MFAS-participants who were randomized (those participants who would have been able to complete Week 24 at time of study discontinuation) and received at least 1 dose of study drug. Participants were analyzed per assigned treatment regardless of actual treatment received.

The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (measurement value at Week 20 and 24 was set as missing). Here 'n' defined as number of participants who were analyzed at each specified timepoint, for each arm, respectively.

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20 Change at Week 20	-1.70 Units on a scale Standard Deviation 2.339	-2.11 Units on a scale Standard Deviation 2.394	-1.64 Units on a scale Standard Deviation 2.794
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20 Change at Week 4	-0.60 Units on a scale Standard Deviation 1.582	-1.15 Units on a scale Standard Deviation 1.748	-0.79 Units on a scale Standard Deviation 1.600
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20 Change at Week 8	-0.82 Units on a scale Standard Deviation 1.997	-1.54 Units on a scale Standard Deviation 2.177	-1.05 Units on a scale Standard Deviation 2.095
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20 Change at Week 12	-1.00 Units on a scale Standard Deviation 2.064	-1.69 Units on a scale Standard Deviation 2.079	-1.35 Units on a scale Standard Deviation 2.458
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20 Change at Week 16	-1.05 Units on a scale Standard Deviation 2.162	-1.75 Units on a scale Standard Deviation 2.312	-1.17 Units on a scale Standard Deviation 2.747

SECONDARY outcome

Timeframe: Week 4, 8, 12, 16, and 20

ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*total back pain)+ (0.110\*PGA)+ (0.073\*peripheral pain/swelling)+ (0.058\* DMS)+ (0.579\*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =\>2 hours). Inactive disease is defined as an ASDAS score \<1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=82 Participants Participants received placebo subcutaneous (SC) at Week 0,4,16 and 20. At Week 16, participants in placebo group who qualified for early escape (EE) criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16,20,28 followed by every 12 Weeks (q12w) through Week 52. Participants received placebo SC at Week 24 to maintain blind. At Week 24, remaining participants in placebo group who did not meet EE criteria, re-randomized to receive ustekinumab 45mg or 90mg at Week 24, 28 followed by q12w through Week 52. At Week 52, participants who achieved inactive disease ASDAS \[ESR\]\<1.3 at Week 40, 52 underwent re-randomization to either ustekinumab or placebo. Participants who did not achieve inactive disease either at Week 40 or 52 received previously assigned ustekinumab dose at scheduled visits. Last dose was scheduled for Week 88 and last study visit for Week 100.	Ustekinumab 45 mg n=83 Participants Participants received ustekinumab 45 mg SC at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.	Ustekinumab 90 mg n=85 Participants Participants received ustekinumab 90 mg SC at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20 Week 4	2.4 Percentage of participants	3.6 Percentage of participants	1.2 Percentage of participants
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20 Week 8	6.1 Percentage of participants	7.2 Percentage of participants	9.4 Percentage of participants
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20 Week 12	4.9 Percentage of participants	4.8 Percentage of participants	10.6 Percentage of participants
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20 Week 16	6.1 Percentage of participants	7.2 Percentage of participants	11.8 Percentage of participants
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20 Week 20	3.7 Percentage of participants	13.3 Percentage of participants	15.3 Percentage of participants

Adverse Events

Placebo Only

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo to Ustekinumab 45mg

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo to Ustekinumab 90mg

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Ustekinumab 45mg Only

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Ustekinumab 90mg Only

Serious events: 6 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Only n=116 participants at risk Participants received placebo SC at Week 0, 4, 16 and 20. At Week 16, participants in placebo group who qualified for EE criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16, 20 and 28 followed by q12w dosing through Week 52. Participants received placebo SC at Week 24 to maintain the blind. At Week 24, remaining participants in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Week 24 and 28 followed by q12w therapy through Week 52. At Week 52, participants who achieved inactive disease \[ASDAS\] \[ESR\]\<1.3 at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned Ustekinumab dose at scheduled visits.	Placebo to Ustekinumab 45mg n=42 participants at risk Participants randomized to placebo SC at Week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 45 mg SC; adverse events are counted from crossover onward. All participants regardless qualified for re-randomization at Week 52 or not were counted.	Placebo to Ustekinumab 90mg n=40 participants at risk Participants randomized to placebo SC at week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 90 mg SC; adverse events are counted from crossover onward. All participants regardless qualified for re-randomization at Week 52 or not were counted.	Ustekinumab 45mg Only n=118 participants at risk Participants received ustekinumab 45 mg subcutaneously (SC) at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR\<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All participants regardless qualified for re-randomization at Week 52 or not were counted.	Ustekinumab 90mg Only n=122 participants at risk Participants received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.At Week 52, all participants who achieved inactive disease (ASDAS ESR\<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All participants regardless qualified for re-randomization at Week 52 or not were counted.
Eye disorders Uveitis	0.86% 1/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Gastrointestinal disorders Inguinal Hernia	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.85% 1/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Infections and infestations Chronic Sinusitis	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.82% 1/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Infections and infestations Gastroenteritis	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.82% 1/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.85% 1/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Musculoskeletal and connective tissue disorders Axial Spondyloarthritis	0.86% 1/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.82% 1/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Musculoskeletal and connective tissue disorders Spondyloarthropathy	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.5% 1/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Psychiatric disorders Panic Attack	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.82% 1/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Renal and urinary disorders Nephrolithiasis	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.5% 1/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Reproductive system and breast disorders Haemorrhagic Ovarian Cyst	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.82% 1/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Reproductive system and breast disorders Menorrhagia	0.00% 0/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.82% 1/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.

Other adverse events

Other adverse events
Measure	Placebo Only n=116 participants at risk Participants received placebo SC at Week 0, 4, 16 and 20. At Week 16, participants in placebo group who qualified for EE criteria (with \<10 % improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16) re-randomized to receive ustekinumab 45mg or 90mg at Week 16, 20 and 28 followed by q12w dosing through Week 52. Participants received placebo SC at Week 24 to maintain the blind. At Week 24, remaining participants in placebo group who did not meet EE criteria were re-randomized to receive ustekinumab 45mg or 90mg at Week 24 and 28 followed by q12w therapy through Week 52. At Week 52, participants who achieved inactive disease \[ASDAS\] \[ESR\]\<1.3 at both Week 40 and 52 underwent re-randomization to either Ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned Ustekinumab dose at scheduled visits.	Placebo to Ustekinumab 45mg n=42 participants at risk Participants randomized to placebo SC at Week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 45 mg SC; adverse events are counted from crossover onward. All participants regardless qualified for re-randomization at Week 52 or not were counted.	Placebo to Ustekinumab 90mg n=40 participants at risk Participants randomized to placebo SC at week 0 and re-randomized to early escape at Week 16 or cross over at Week 24 to ustekinumab 90 mg SC; adverse events are counted from crossover onward. All participants regardless qualified for re-randomization at Week 52 or not were counted.	Ustekinumab 45mg Only n=118 participants at risk Participants received ustekinumab 45 mg subcutaneously (SC) at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind. At Week 52, all participants who achieved inactive disease (ASDAS ESR\<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All participants regardless qualified for re-randomization at Week 52 or not were counted.	Ustekinumab 90mg Only n=122 participants at risk Participants received ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants received placebo subcutaneously to maintain the blind.At Week 52, all participants who achieved inactive disease (ASDAS ESR\<1.3) at both Week 40 and 52 underwent re-randomization to either remain on ustekinumab or placebo. Participants who did not achieve inactive disease at either Week 40 or 52 received previously assigned ustekinumab dose at their scheduled visits. All participants regardless qualified for re-randomization at Week 52 or not were counted.
Gastrointestinal disorders Diarrhoea	0.86% 1/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.4% 1/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	5.0% 2/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	1.7% 2/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	1.6% 2/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
General disorders Fatigue	1.7% 2/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	10.0% 4/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.85% 1/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	1.6% 2/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Infections and infestations Sinusitis	0.86% 1/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.4% 1/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	5.0% 2/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Infections and infestations Upper Respiratory Tract Infection	4.3% 5/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	4.8% 2/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	5.0% 2/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	4.2% 5/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	6.6% 8/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Infections and infestations Viral Upper Respiratory Tract Infection	5.2% 6/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.4% 1/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.5% 1/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	9.3% 11/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	7.4% 9/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Investigations Alanine Aminotransferase Increased	2.6% 3/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.4% 1/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	5.0% 2/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	4.2% 5/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	3.3% 4/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Musculoskeletal and connective tissue disorders Arthralgia	1.7% 2/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	5.0% 2/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.85% 1/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.5% 3/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Musculoskeletal and connective tissue disorders Back Pain	1.7% 2/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.4% 1/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	7.5% 3/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	1.7% 2/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.5% 3/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.
Nervous system disorders Headache	0.86% 1/116 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	0.00% 0/42 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	5.0% 2/40 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	2.5% 3/118 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.	3.3% 4/122 • Approximately up to 2.2 years The safety analysis set included all participants who received at least 1 (partial or complete) administration of study agent, i.e., the treated population. In the safety analyses, participants were analyzed according to the treatment they actually received, regardless of their randomized treatments.

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