Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis (NCT NCT02437162)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

347 participants

Primary outcome timeframe

Week 24

Results posted on

2025-04-29

Participant Flow

A total of 347 participants were randomized, and 346 participants were treated (116 participants to placebo, 116 participants to ustekinumab 45 mg, and 114 participants to 90 mg).

Participant milestones

Participant milestones
Measure	Placebo Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 mg Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Study STARTED	116	116	115
Overall Study Treated	116	116	114
Overall Study Early Escape at Week 16	26	21	14
Overall Study Cross Over at Week 24	87	0	0
Overall Study COMPLETED	9	8	6
Overall Study NOT COMPLETED	107	108	109

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 mg Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Overall Study Protocol Violation	0	1	0
Overall Study Randomized but not treated	0	0	1
Overall Study Study discontinued by Sponsor	93	98	97
Overall Study Withdrawal by Subject	13	7	9
Overall Study Adverse Event	0	1	0
Overall Study Lost to Follow-up	1	0	1
Overall Study Death	0	1	0
Overall Study Other	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 mg n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Total n=346 Participants Total of all reporting groups
Age, Continuous	38.3 years STANDARD_DEVIATION 11.35 • n=5 Participants	39.2 years STANDARD_DEVIATION 10.5 • n=7 Participants	39.5 years STANDARD_DEVIATION 11.32 • n=5 Participants	39 years STANDARD_DEVIATION 11.04 • n=4 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	23 Participants n=7 Participants	14 Participants n=5 Participants	52 Participants n=4 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	93 Participants n=7 Participants	100 Participants n=5 Participants	294 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	112 Participants n=5 Participants	116 Participants n=7 Participants	113 Participants n=5 Participants	341 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 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	30 Participants n=5 Participants	32 Participants n=7 Participants	31 Participants n=5 Participants	93 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	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	86 Participants n=5 Participants	84 Participants n=7 Participants	82 Participants n=5 Participants	252 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	30 Participants n=5 Participants	32 Participants n=7 Participants	31 Participants n=5 Participants	93 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized White Non-Hispanic	82 Participants n=5 Participants	84 Participants n=7 Participants	81 Participants n=5 Participants	247 Participants n=4 Participants
Region of Enrollment Poland	19 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	50 Participants n=4 Participants
Region of Enrollment Ukraine	19 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	61 Participants n=4 Participants
Region of Enrollment United States	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment Russia	32 Participants n=5 Participants	38 Participants n=7 Participants	31 Participants n=5 Participants	101 Participants n=4 Participants
Region of Enrollment Korea, Democratic People'S Republic Of	9 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment Taiwan, Province Of China	23 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	67 Participants n=4 Participants
Region of Enrollment Czech Republic	12 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	33 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 24

Population: The full analysis set (FAS) included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

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

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 40 Response at Week 24	28.4 Percentage of participants	31.0 Percentage of participants	28.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

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

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved an Assessment of Spondyloarthritis International Society (ASAS) 20 Response at Week 24	44.8 Percentage of participants	55.2 Percentage of participants	50.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set (FAS) included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

BASDAI used to measure ankylosing spondylitis (AS) disease severity. Consists of 6 questions: fatigue,spinal pain,arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons, ligaments),morning stiffness(MS) (2 questions:duration, severity). Each question is easy to answer 10cm VAS, 0(none),10(very severe) and for the last question related to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each 5 symptoms equal weight, mean of 2 questions about MS added to total of remaining 4 scores,final BASDAI score(ranging 0-10) is average of overall total score. Higher BASDAI indicates more severe AS symptom. 50% improvement from baseline based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rule(consider non-responder at W20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved at Least a 50 Percent (%) Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24	27.6 Percentage of participants	25.0 Percentage of participants	25.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.

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

Outcome measures

Outcome measures
Measure	Placebo n=88 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=95 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=99 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) Total Score at Week 24	-1.85 Units on a scale Standard Deviation 2.133	-2.11 Units on a scale Standard Deviation 2.266	-2.07 Units on a scale Standard Deviation 2.502

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

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

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score-C Reactive Protein (ASDAS-CRP) Inactive Disease (<1.3) at Week 24	3.4 Percentage of participants	1.7 Percentage of participants	2.6 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied(measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 4	-0.10 Milligrams per deciliter (mg/dL) Standard Deviation 1.459	-0.54 Milligrams per deciliter (mg/dL) Standard Deviation 1.488	-0.74 Milligrams per deciliter (mg/dL) Standard Deviation 1.839
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 8	-0.16 Milligrams per deciliter (mg/dL) Standard Deviation 1.478	-0.59 Milligrams per deciliter (mg/dL) Standard Deviation 1.236	-0.66 Milligrams per deciliter (mg/dL) Standard Deviation 2.213
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 12	-0.18 Milligrams per deciliter (mg/dL) Standard Deviation 1.571	-0.80 Milligrams per deciliter (mg/dL) Standard Deviation 1.853	-0.84 Milligrams per deciliter (mg/dL) Standard Deviation 2.262
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 16	-0.11 Milligrams per deciliter (mg/dL) Standard Deviation 1.456	-0.39 Milligrams per deciliter (mg/dL) Standard Deviation 3.166	-0.86 Milligrams per deciliter (mg/dL) Standard Deviation 2.261
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 20	-0.34 Milligrams per deciliter (mg/dL) Standard Deviation 1.450	-0.73 Milligrams per deciliter (mg/dL) Standard Deviation 1.792	-0.79 Milligrams per deciliter (mg/dL) Standard Deviation 2.240
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 Change at Week 24	-0.41 Milligrams per deciliter (mg/dL) Standard Deviation 1.737	-0.72 Milligrams per deciliter (mg/dL) Standard Deviation 1.617	-0.92 Milligrams per deciliter (mg/dL) Standard Deviation 2.274

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: Population included subset of FAS with enthesitis at baseline. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm.

Assessment of enthesitis was performed in the following 7 domains: 1) 1st costochondral joint left and right, 2) 7th costochondral joint left and right, 3) posterior superior iliac spine left and right, 4) anterior superior iliac spine left and right, 5) iliac crest left and right, 6) 5th lumbar spinous process and 7) proximal insertion of Achilles tendon left and right. Entheses were scored as either 0 (nontender) or 1 (tender) yielding total MASES ranging from 0 (no tenderness) to 13 (worst possible score; severe tenderness). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=87 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=92 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=83 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) Total Score at Week 16 and 24 Change at Week 24	-1.66 Units on a scale Standard Deviation 3.481	-1.84 Units on a scale Standard Deviation 3.301	-1.73 Units on a scale Standard Deviation 3.060
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) Total Score at Week 16 and 24 Change at Week 16	-1.53 Units on a scale Standard Deviation 3.347	-1.47 Units on a scale Standard Deviation 3.564	-1.17 Units on a scale Standard Deviation 3.101

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The Bath Ankylosing Spondylitis Metrology Index linear function is a combined index of 5 clinical measurements (performed by the Joint Assessor) which reflect axial mobility in the AS patient. The measurements to assess mobility are: 1)Tragus-to-wall; 2)Modified Schober (lumbar flexion); 3)Cervical rotation angle; 4)Lateral spinal flexion; 5)Intermalleolar distance. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. Early escape rule was applied (measurement value was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 and 24 Change at Week 16	-0.26 Units on a scale Standard Deviation 1.015	-0.26 Units on a scale Standard Deviation 1.044	-0.17 Units on a scale Standard Deviation 0.840
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 16 and 24 Change at Week 24	-0.36 Units on a scale Standard Deviation 0.943	-0.37 Units on a scale Standard Deviation 0.946	-0.27 Units on a scale Standard Deviation 0.877

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The ASQoL is a self-administered health-related quality of life (HRQOL) instrument. It consists of 18 items requesting a Yes or No response to questions related to the impact of the disease/condition (including pain) on sleep, mood, motivation, ability to cope, activities of daily living, independence, relationships, and social life. A score of 1 is given to a response of "yes" on each item and all item scores are summed to a total score with a range of 0 to 18. Higher scores indicate worse HRQOL. Early escape rule was applied (measurement value was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) Score at Week 16 and 24 Change at Week 16	-2.61 Units on a scale Standard Deviation 4.385	-3.03 Units on a scale Standard Deviation 4.416	-2.93 Units on a scale Standard Deviation 3.954
Change From Baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) Score at Week 16 and 24 Change at Week 24	-4.21 Units on a scale Standard Deviation 4.441	-4.48 Units on a scale Standard Deviation 4.808	-4.31 Units on a scale Standard Deviation 4.537

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). Early escape rule was applied (measurement value was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 and 24 Change at Week 16	5.71 Units on a scale Standard Deviation 9.499	5.44 Units on a scale Standard Deviation 9.528	5.96 Units on a scale Standard Deviation 9.325
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16 and 24 Change at Week 24	8.78 Units on a scale Standard Deviation 10.472	7.67 Units on a scale Standard Deviation 10.348	8.59 Units on a scale Standard Deviation 10.597

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The Medical Outcome Study health measure SF-36 questionnaire is a well-validated and widely used quality-of-life instrument. It is a self-administered survey that consists of 8 multi-item scales: The 4 subscales of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and the 4 subscales of the SF-36 comprises the MCS score(vitality, social functioning, role-emotional, and mental health). PCS and MCS are scored from 0 to 100 with higher scores indicating better health (worst value is 0 and best value is 100), which are scored using a norm-based system where linear transformations are performed to transform scores to a mean of 50 and standard deviation of 10. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Short Form-(SF)-36 Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS) at Week 16 and 24 SF-36 MCS; change at Week 16	4.56 Units on a scale Standard Deviation 9.113	3.69 Units on a scale Standard Deviation 9.690	4.06 Units on a scale Standard Deviation 9.034
Change From Baseline in Short Form-(SF)-36 Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS) at Week 16 and 24 SF-36 PCS; change at Week 16	4.09 Units on a scale Standard Deviation 7.618	3.66 Units on a scale Standard Deviation 6.172	5.17 Units on a scale Standard Deviation 6.494
Change From Baseline in Short Form-(SF)-36 Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS) at Week 16 and 24 SF-36 PCS; change at Week 24	7.69 Units on a scale Standard Deviation 8.001	6.34 Units on a scale Standard Deviation 6.198	7.20 Units on a scale Standard Deviation 7.343
Change From Baseline in Short Form-(SF)-36 Physical Component Summary (PCS) and SF-36 Mental Component Summary (MCS) at Week 16 and 24 SF-36 MCS; change at Week 24	5.05 Units on a scale Standard Deviation 9.758	4.82 Units on a scale Standard Deviation 10.841	5.46 Units on a scale Standard Deviation 8.911

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration, severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). Change from baseline in inflammation was assessed by calculating the average of the Last 2 Questions of the BASDAI Concerning Morning Stiffness. Early escape rule was applied (measurement value was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in BASDAI Inflammation Score Through Week 24 Week 12	-1.63 Units on a scale Standard Deviation 2.110	-1.89 Units on a scale Standard Deviation 2.143	-1.88 Units on a scale Standard Deviation 2.110
Change From Baseline in BASDAI Inflammation Score Through Week 24 Week 16	-1.82 Units on a scale Standard Deviation 2.221	-1.98 Units on a scale Standard Deviation 2.394	-1.97 Units on a scale Standard Deviation 2.299
Change From Baseline in BASDAI Inflammation Score Through Week 24 Week 20	-2.48 Units on a scale Standard Deviation 2.200	-2.61 Units on a scale Standard Deviation 2.089	-2.51 Units on a scale Standard Deviation 2.429
Change From Baseline in BASDAI Inflammation Score Through Week 24 Week 24	-2.64 Units on a scale Standard Deviation 2.194	-2.81 Units on a scale Standard Deviation 2.257	-2.74 Units on a scale Standard Deviation 2.592
Change From Baseline in BASDAI Inflammation Score Through Week 24 Week 4	-0.86 Units on a scale Standard Deviation 1.650	-1.09 Units on a scale Standard Deviation 1.748	-1.25 Units on a scale Standard Deviation 1.871
Change From Baseline in BASDAI Inflammation Score Through Week 24 Week 8	-1.45 Units on a scale Standard Deviation 1.970	-1.80 Units on a scale Standard Deviation 2.192	-1.88 Units on a scale Standard Deviation 2.160

SECONDARY outcome

Timeframe: Baseline, Week (W) 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, and Quantity of sleep(QS)/optimal sleep(OS) during the past 4 weeks. The six dimensions were also used to generate the composite Sleep Problems Index (SPI). An increase in score from baseline represents improvement. Sleep disturbance, snoring, somnolence, awaken short of breath, sleep problems index have score ranges from 0(no sleep problems) to 100 (greater sleep problems), negative change indicates improvement. Sleep adequacy scored 0 (least sleep adequacy) to 100 (better sleep adequacy), positive change indicates improvement. Quantity of sleep is scored 0 (less quantity of sleep) to 24 (greater quantity of sleep), positive change indicates improvement. Early escape rule was applied (measurement value was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W16: sleep disturbance	3.15 Units on a scale Standard Deviation 7.103	4.13 Units on a scale Standard Deviation 7.815	2.79 Units on a scale Standard Deviation 6.233
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W24: sleep disturbance	4.57 Units on a scale Standard Deviation 7.335	5.85 Units on a scale Standard Deviation 8.991	4.79 Units on a scale Standard Deviation 7.232
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W16: somnolence	3.79 Units on a scale Standard Deviation 7.996	2.06 Units on a scale Standard Deviation 7.901	2.73 Units on a scale Standard Deviation 8.525
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W24: somnolence	4.99 Units on a scale Standard Deviation 8.019	3.16 Units on a scale Standard Deviation 8.612	4.52 Units on a scale Standard Deviation 9.131
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W16: sleep adequacy	1.78 Units on a scale Standard Deviation 7.713	1.42 Units on a scale Standard Deviation 9.301	1.50 Units on a scale Standard Deviation 7.851
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change-W24: sleep adequacy	3.03 Units on a scale Standard Deviation 7.245	1.75 Units on a scale Standard Deviation 9.148	3.41 Units on a scale Standard Deviation 7.689
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W16: snoring	0.47 Units on a scale Standard Deviation 7.026	1.24 Units on a scale Standard Deviation 5.753	1.14 Units on a scale Standard Deviation 6.520
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W24: snoring	0.86 Units on a scale Standard Deviation 7.506	1.21 Units on a scale Standard Deviation 6.715	2.64 Units on a scale Standard Deviation 7.569
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W16:awaken short of breath or headache	3.93 Units on a scale Standard Deviation 12.209	3.66 Units on a scale Standard Deviation 11.355	5.53 Units on a scale Standard Deviation 12.602
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change-W24:awaken short of breath or headache	3.48 Units on a scale Standard Deviation 11.179	2.76 Units on a scale Standard Deviation 11.385	3.97 Units on a scale Standard Deviation 12.426
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W16: sleep problems index	3.72 Units on a scale Standard Deviation 7.341	3.76 Units on a scale Standard Deviation 8.160	3.19 Units on a scale Standard Deviation 6.695
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS) at Week 16 and 24 Change at W24:sleep problems index	5.10 Units on a scale Standard Deviation 7.338	4.96 Units on a scale Standard Deviation 8.794	5.16 Units on a scale Standard Deviation 7.795

SECONDARY outcome

Timeframe: Baseline, Week (W) 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

Sleep problems were assessed using the 12-item MOS-SS, a generic instrument designed to assess six dimensions of sleep: Sleep disturbance, Somnolence, Sleep adequacy, Snoring, Awaken short of breath or headache, QS/OS during past W4. 6 dimensions used to generate composite SPI. Increase in score from baseline represents improvement. Sleep adequacy scored 0 (least sleep adequacy\[SA\]) to 100 (better SA), positive change indicates improvement. QS is scored 0 (less QS) to 24 (greater QS), positive change indicates improvement. Single-item QS asks participants to estimate average number of hours they slept each night during past 4W (0-24 hours) and transformed into dichotomous OS Score, reported 7 (or 8) hours of sleep considered Optimal. OS is scored Yes if average hours of sleep is in range of 7-8 hours. Early escape rule was applied (measurement value was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS)-Quantity of Sleep/Optimal Sleep at Week 16 and 24 Change-W16: quantity of sleep/optimal sleep	0.15 Hours Standard Deviation 0.502	0.06 Hours Standard Deviation 0.548	0.04 Hours Standard Deviation 0.557
Change From Baseline in Composite and Domain Scores of Medical Outcomes Study Sleep Scale (MOS-SS)-Quantity of Sleep/Optimal Sleep at Week 16 and 24 Change-W24: quantity of sleep/optimal sleep	0.16 Hours Standard Deviation 0.500	0.07 Hours Standard Deviation 0.626	0.12 Hours Standard Deviation 0.579

SECONDARY outcome

Timeframe: Week 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this endpoint.

ASAS 40 components included Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe). Percentage of Participants With at least a 40% improvement from baseline in each of the ASAS components was calculated.

Outcome measures

Outcome measures
Measure	Placebo n=114 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=115 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=113 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants With at Least a 40% Improvement From Baseline in ASAS 40 Components at Week 24 Patients global assessment	43.0 Percentage of participants	35.7 Percentage of participants	31.9 Percentage of participants
Percentage of Participants With at Least a 40% Improvement From Baseline in ASAS 40 Components at Week 24 Total back pain	42.1 Percentage of participants	42.6 Percentage of participants	38.9 Percentage of participants
Percentage of Participants With at Least a 40% Improvement From Baseline in ASAS 40 Components at Week 24 BASFI	32.5 Percentage of participants	33.0 Percentage of participants	35.4 Percentage of participants
Percentage of Participants With at Least a 40% Improvement From Baseline in ASAS 40 Components at Week 24 Inflammation	47.4 Percentage of participants	36.5 Percentage of participants	37.2 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

BASDAI used to measure the AS disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer cm VAS with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, mean of 2 questions about morning stiffness will be added to total of remaining 4 scores, final BASDAI score (ranging 0-10) is average of overall total score. Higher BASDAI score indicates more severe AS symptom. 20 %,50%, 70%,90% improvement from baseline in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 16 (90% improvement)	1.7 Percentage of participants	1.7 Percentage of participants	0.9 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 4 (20% improvement)	25.9 Percentage of participants	28.4 Percentage of participants	35.1 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 8 (20% improvement)	44.8 Percentage of participants	45.7 Percentage of participants	43.0 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 12 (20% improvement)	47.4 Percentage of participants	45.7 Percentage of participants	41.2 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 16 (20% improvement)	49.1 Percentage of participants	46.6 Percentage of participants	48.2 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 20 (20% improvement)	43.1 Percentage of participants	51.7 Percentage of participants	50.0 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 24 (20% improvement)	47.4 Percentage of participants	55.2 Percentage of participants	51.8 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 4 (50% improvement)	3.4 Percentage of participants	4.3 Percentage of participants	5.3 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 8 (50% improvement)	12.9 Percentage of participants	12.9 Percentage of participants	14.0 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 12 (50% improvement)	19.0 Percentage of participants	12.9 Percentage of participants	14.0 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 16 (50% improvement)	19.8 Percentage of participants	17.2 Percentage of participants	18.4 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 20 (50% improvement)	25.9 Percentage of participants	17.2 Percentage of participants	22.8 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 4 (70% improvement)	0.9 Percentage of participants	0.9 Percentage of participants	1.8 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 8 (70% improvement)	6.9 Percentage of participants	4.3 Percentage of participants	5.3 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 12(70 % response)	6.9 Percentage of participants	6.9 Percentage of participants	7.9 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 16(70 % response)	10.3 Percentage of participants	9.5 Percentage of participants	8.8 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 20 (70% improvement)	11.2 Percentage of participants	6.9 Percentage of participants	10.5 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 24 (70% improvement)	11.2 Percentage of participants	11.2 Percentage of participants	11.4 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 4 (90% improvement)	0 Percentage of participants	0.9 Percentage of participants	0 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 8 (90% improvement)	0.9 Percentage of participants	0 Percentage of participants	1.8 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 12 (90% improvement)	1.7 Percentage of participants	0.9 Percentage of participants	1.8 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 20 (90% improvement)	2.6 Percentage of participants	0.9 Percentage of participants	1.8 Percentage of participants
Percentage of Participants Who Achieved at Least 20%, 50%, 70% and 90% Improvement From Baseline in BASDAI Through Week 24 Week 24 (90% improvement)	4.3 Percentage of participants	1.7 Percentage of participants	4.4 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe and for the last question relating to morning stiffness duration: 0(0 hours), 10(2 or more hours). In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in BASDAI Total Score Through Week 24 Change at Week 4	-0.83 Units on a scale Standard Deviation 1.340	-0.92 Units on a scale Standard Deviation 1.550	-0.87 Units on a scale Standard Deviation 1.632
Change From Baseline in BASDAI Total Score Through Week 24 Change at Week 8	-1.43 Units on a scale Standard Deviation 1.849	-1.67 Units on a scale Standard Deviation 1.984	-1.49 Units on a scale Standard Deviation 2.025
Change From Baseline in BASDAI Total Score Through Week 24 Change at Week 12	-1.59 Units on a scale Standard Deviation 2.073	-1.64 Units on a scale Standard Deviation 2.047	-1.45 Units on a scale Standard Deviation 2.118
Change From Baseline in BASDAI Total Score Through Week 24 Change at Week 16	-1.67 Units on a scale Standard Deviation 2.271	-1.74 Units on a scale Standard Deviation 2.300	-1.60 Units on a scale Standard Deviation 2.276
Change From Baseline in BASDAI Total Score Through Week 24 Change at Week 20	-2.35 Units on a scale Standard Deviation 2.226	-2.39 Units on a scale Standard Deviation 1.922	-2.20 Units on a scale Standard Deviation 2.283
Change From Baseline in BASDAI Total Score Through Week 24 Change at Week 24	-2.52 Units on a scale Standard Deviation 2.262	-2.56 Units on a scale Standard Deviation 2.196	-2.40 Units on a scale Standard Deviation 2.356

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

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

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 4	7.8 Percentage of participants	6.9 Percentage of participants	8.8 Percentage of participants
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 8	14.7 Percentage of participants	18.1 Percentage of participants	19.3 Percentage of participants
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 12	19.8 Percentage of participants	14.7 Percentage of participants	18.4 Percentage of participants
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 16	22.4 Percentage of participants	21.6 Percentage of participants	22.8 Percentage of participants
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 Week 20	22.4 Percentage of participants	22.4 Percentage of participants	28.9 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

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

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 4	20.7 Percentage of participants	27.6 Percentage of participants	29.8 Percentage of participants
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 8	33.6 Percentage of participants	41.4 Percentage of participants	42.1 Percentage of participants
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 12	37.1 Percentage of participants	44.8 Percentage of participants	39.5 Percentage of participants
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 16	44.0 Percentage of participants	45.7 Percentage of participants	43.9 Percentage of participants
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 Week 20	39.7 Percentage of participants	46.6 Percentage of participants	49.1 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

Low level of disease activity was measured by criteria for ASAS partial remission, defined as a value below 2 on a scale of 0 to 10 cm in each of the 4 ASAS domains: patient's global assessment of disease activity, total back pain, function (BASFI), inflammation. ASAS partial remission response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24 Week 24	6.9 Percentage of participants	5.2 Percentage of participants	6.1 Percentage of participants
Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24 Week 4	1.7 Percentage of participants	0 Percentage of participants	0.9 Percentage of participants
Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24 Week 8	3.4 Percentage of participants	0.9 Percentage of participants	3.5 Percentage of participants
Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24 Week 12	4.3 Percentage of participants	4.3 Percentage of participants	3.5 Percentage of participants
Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24 Week 16	8.6 Percentage of participants	5.2 Percentage of participants	2.6 Percentage of participants
Percentage of Participants Who Achieved Assessment of Spondyloarthritis International Society (ASAS) Partial Remission Through Week 24 Week 20	7.8 Percentage of participants	3.4 Percentage of participants	6.1 Percentage of participants

SECONDARY outcome

Timeframe: Week 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

ASAS 5/6 is defined as a \>=20% improvement in any 5 of the 6 domains of pain (VAS 0 to 10), patient global (VAS 0 to 10), function (BASFI score), morning stiffness (from BASDAI), hsCRP, and spine mobility (lumbar side flexion). ASAS 5/6 response is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder\[NRI\] (missing responses at post baseline visit imputed as non-responder).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved ASAS 5/6 Response at Week 16 and 24 Week 16	23.3 Percentage of participants	29.3 Percentage of participants	26.3 Percentage of participants
Percentage of Participants Who Achieved ASAS 5/6 Response at Week 16 and 24 Week 24	30.2 Percentage of participants	35.3 Percentage of participants	33.3 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

ASDAS includes CRP mg/L; 4 additional self-reported items (rated 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*TBP)+(0.110\*PGA) + (0.073\*peripheral pain(PP)/swelling)+(0.058\* duration of morning stiffness)+(0.579\*Ln(CRP+1)). The disease activity, TBP, and PP/swelling on a NRS(0\[normal\]-10\[very severe\]and DMS on NRS(0 to 10, 0 being none and 10 representing a duration=\>2 hours). The scores were categorized as: inactive disease (\< 1.3), moderate (1.3 - \< 2.1), high (2.1 - 3.5) and very high disease activity (\> 3.5). The calculated score can be from 0 to no defined upper limit. A negative number indicates a reduction in the score which indicates decrease in disease activity. Early escape rule was applied (measurement value was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24 Change at Week 4	-0.41 Units on a scale Standard Deviation 0.705	-0.52 Units on a scale Standard Deviation 0.616	-0.55 Units on a scale Standard Deviation 0.673
Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24 Change at Week 8	-0.62 Units on a scale Standard Deviation 0.881	-0.80 Units on a scale Standard Deviation 0.764	-0.75 Units on a scale Standard Deviation 0.875
Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24 Change at Week 12	-0.66 Units on a scale Standard Deviation 0.957	-0.87 Units on a scale Standard Deviation 0.800	-0.76 Units on a scale Standard Deviation 0.881
Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24 Change at Week 16	-0.67 Units on a scale Standard Deviation 1.044	-0.85 Units on a scale Standard Deviation 0.972	-0.80 Units on a scale Standard Deviation 0.926
Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24 Change at Week 20	-1.00 Units on a scale Standard Deviation 1.033	-1.13 Units on a scale Standard Deviation 0.844	-1.01 Units on a scale Standard Deviation 0.982
Change From Baseline in Ankylosing Spondylitis Disease Activity Score ASDAS (CRP) Total Score Through Week 24 Change at Week 24	-1.10 Units on a scale Standard Deviation 1.088	-1.19 Units on a scale Standard Deviation 0.985	-1.12 Units on a scale Standard Deviation 1.005

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

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

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 Week 4	0.9 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 Week 8	0.9 Percentage of participants	0.9 Percentage of participants	2.6 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 Week 12	1.7 Percentage of participants	0.9 Percentage of participants	0.9 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 Week 16	1.7 Percentage of participants	1.7 Percentage of participants	2.6 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16 and 20 Week 20	4.3 Percentage of participants	0.9 Percentage of participants	2.6 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale \[NRS\]) included are total back pain (TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*TBP) + (0.110\*participant global) + (0.073\*peripheral pain/swelling) + (0.058\* DMS) + (0.579\*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =\>2 hours). Major improvement in ASDAS is defined as a decrease from baseline \>=2.0. ASDAS (CRP) major improvement (decrease \>=2.0) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24 Week 4	2.6 Percentage of participants	3.4 Percentage of participants	3.5 Percentage of participants
Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24 Week 8	6.9 Percentage of participants	8.6 Percentage of participants	12.3 Percentage of participants
Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24 Week 12	8.6 Percentage of participants	9.5 Percentage of participants	12.3 Percentage of participants
Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24 Week 16	10.3 Percentage of participants	13.8 Percentage of participants	14.0 Percentage of participants
Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24 Week 20	7.8 Percentage of participants	15.5 Percentage of participants	10.5 Percentage of participants
Percentage of Participants With ASDAS (CRP) Major Improvement (Decrease >=2.0) Through Week 24 Week 24	13.8 Percentage of participants	16.4 Percentage of participants	14.9 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received.

ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 NRS) included are TBP, duration of DMS, peripheral pain/swelling and patient global assessment (PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121\*TBP) + (0.110\*participant global) + (0.073\*peripheral pain/swelling) + (0.058\*DMS) + (0.579\*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =\>2 hours). Clinically important improvement in ASDAS is defined as a decrease from baseline \>=1.1. ASDAS (CRP) clinical important improvement (decrease \>=1.1) is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non- responders).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24 Week 4	16.4 Percentage of participants	13.8 Percentage of participants	17.5 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24 Week 8	26.7 Percentage of participants	31.0 Percentage of participants	30.7 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24 Week 12	28.4 Percentage of participants	37.9 Percentage of participants	28.1 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24 Week 16	32.8 Percentage of participants	35.3 Percentage of participants	28.1 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24 Week 20	29.3 Percentage of participants	31.9 Percentage of participants	37.7 Percentage of participants
Percentage of Participants Who Achieved ASDAS (CRP) Clinically Important Improvement (Decrease >=1.1) Through Week 24 Week 24	37.9 Percentage of participants	40.5 Percentage of participants	37.7 Percentage of participants

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

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

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20 Change at Week 4	-0.77 Units on a scale Standard Deviation 1.635	-0.80 Units on a scale Standard Deviation 1.359	-0.90 Units on a scale Standard Deviation 1.524
Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20 Change at Week 8	-1.13 Units on a scale Standard Deviation 1.841	-1.29 Units on a scale Standard Deviation 1.904	-1.29 Units on a scale Standard Deviation 1.841
Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20 Change at Week 12	-1.09 Units on a scale Standard Deviation 2.015	-1.22 Units on a scale Standard Deviation 1.854	-1.34 Units on a scale Standard Deviation 2.001
Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20 Change at Week 16	-1.08 Units on a scale Standard Deviation 2.179	-1.35 Units on a scale Standard Deviation 2.113	-1.43 Units on a scale Standard Deviation 2.125
Change From Baseline in BASFI at Week 4, 8, 12, 16 and 20 Change at Week 20	-1.71 Units on a scale Standard Deviation 2.160	-1.94 Units on a scale Standard Deviation 1.946	-2.01 Units on a scale Standard Deviation 2.291

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. It is measured at the level of the fourth intercostal space in males, and just below the breasts in females. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Chest Expansion at Week 16 and 24 Change at Week 24	-0.16 centimeter(cm) Standard Deviation 2.370	0.32 centimeter(cm) Standard Deviation 1.939	-0.21 centimeter(cm) Standard Deviation 2.232
Change From Baseline in Chest Expansion at Week 16 and 24 Change at Week 16	0.43 centimeter(cm) Standard Deviation 7.899	0.20 centimeter(cm) Standard Deviation 2.209	-0.02 centimeter(cm) Standard Deviation 2.240

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The total back pain and nighttime back pain was measured on a VAS (0 to 10 cm; 0 = no pain, 10 = most severe pain). Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 4: TBP	-1.13 centimeter Standard Deviation 2.019	-1.15 centimeter Standard Deviation 1.911	-1.52 centimeter Standard Deviation 1.895
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 4: NBP	-1.05 centimeter Standard Deviation 2.270	-1.25 centimeter Standard Deviation 1.835	-1.19 centimeter Standard Deviation 2.082
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 8: TBP	-1.80 centimeter Standard Deviation 2.190	-1.78 centimeter Standard Deviation 2.294	-2.20 centimeter Standard Deviation 2.243
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 8: NBP	-1.69 centimeter Standard Deviation 2.264	-1.85 centimeter Standard Deviation 2.122	-2.01 centimeter Standard Deviation 2.517
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 12: TBP	-1.81 centimeter Standard Deviation 2.295	-1.70 centimeter Standard Deviation 2.218	-1.84 centimeter Standard Deviation 2.288
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 12: NBP	-1.61 centimeter Standard Deviation 2.342	-1.79 centimeter Standard Deviation 2.127	-1.76 centimeter Standard Deviation 2.554
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 16: TBP	-1.80 centimeter Standard Deviation 2.374	-1.87 centimeter Standard Deviation 2.465	-2.07 centimeter Standard Deviation 2.387
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 16: NBP	-1.76 centimeter Standard Deviation 2.506	-2.02 centimeter Standard Deviation 2.541	-2.05 centimeter Standard Deviation 2.606
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 20: TBP	-2.73 centimeter Standard Deviation 2.456	-2.74 centimeter Standard Deviation 2.088	-2.69 centimeter Standard Deviation 2.414
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 20: NBP	-2.67 centimeter Standard Deviation 2.602	-2.73 centimeter Standard Deviation 2.246	-2.83 centimeter Standard Deviation 2.804
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 24: TBP	-2.80 centimeter Standard Deviation 2.528	-2.90 centimeter Standard Deviation 2.389	-2.77 centimeter Standard Deviation 2.511
Change From Baseline in Total Back Pain (TBP) and Night Back Pain (NBP) Through Week 24 Change at Week 24: NBP	-2.75 centimeter Standard Deviation 2.597	-2.79 centimeter Standard Deviation 2.367	-2.68 centimeter Standard Deviation 2.960

SECONDARY outcome

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

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

Participants assessed their disease activity using a 10 cm visual analog scale, with responses ranging from 0 (very well) to 10 (very poor). Early escape rule was applied (The measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24 Change at Week 20	-2.10 Units on a scale Standard Deviation 2.272	-2.17 Units on a scale Standard Deviation 2.225	-2.36 Units on a scale Standard Deviation 2.283
Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24 Change at Week 24	-2.37 Units on a scale Standard Deviation 2.298	-2.55 Units on a scale Standard Deviation 2.664	-2.50 Units on a scale Standard Deviation 2.379
Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24 Change at Week 4	-0.99 Units on a scale Standard Deviation 1.727	-1.01 Units on a scale Standard Deviation 1.677	-1.21 Units on a scale Standard Deviation 1.645
Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24 Change at Week 8	-1.48 Units on a scale Standard Deviation 2.086	-1.60 Units on a scale Standard Deviation 2.039	-1.70 Units on a scale Standard Deviation 2.096
Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24 Change at Week 12	-1.52 Units on a scale Standard Deviation 2.043	-1.53 Units on a scale Standard Deviation 2.100	-1.77 Units on a scale Standard Deviation 2.088
Change From Baseline in Patients Global Assessment of Disease Activity Through Week 24 Change at Week 16	-1.64 Units on a scale Standard Deviation 2.259	-1.73 Units on a scale Standard Deviation 2.564	-1.77 Units on a scale Standard Deviation 2.293

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The EQ-5D questionnaire is a brief, generic health-related quality of life assessment (HRQOL) that can also be used to incorporate participant preferences into health economic evaluations. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a visual analog scale with response options ranging from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale (VAS) Score at Week 16 and 24 Change at Week 16	11.49 Units on a scale Standard Deviation 20.328	11.26 Units on a scale Standard Deviation 23.588	13.36 Units on a scale Standard Deviation 22.110
Change From Baseline in European Quality of Life 5 Dimension (EQ-5D) Visual Analog Scale (VAS) Score at Week 16 and 24 Change at Week 24	17.57 Units on a scale Standard Deviation 20.251	13.90 Units on a scale Standard Deviation 26.132	16.80 Units on a scale Standard Deviation 22.181

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included all participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The EuroQol-5 is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "full health" and 0 representing death. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in EQ-5D Index Score at Week 16 and 24 Week 16	0.08 Units on a scale Standard Deviation 0.138	0.09 Units on a scale Standard Deviation 0.154	0.10 Units on a scale Standard Deviation 0.139
Change From Baseline in EQ-5D Index Score at Week 16 and 24 Week 24	0.12 Units on a scale Standard Deviation 0.137	0.12 Units on a scale Standard Deviation 0.168	0.13 Units on a scale Standard Deviation 0.153

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Population included subset of FAS with participants who did not meet early escape criteria and have both baseline and Week 24 MRI assessments.

The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI-a) scoring technique assesses inflammation in each of the 23 disc vertebral units (DVU), capturing edema and erosion. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema \[less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)\]. The composite score ranges from 0 to 69, with higher scores indicating more severe inflammation.

Outcome measures

Outcome measures
Measure	Placebo n=23 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=18 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=26 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Berlin Magnetic Resonance Imaging (MRI) Spine Score at Week 24	-0.48 Units on a scale Standard Deviation 2.053	-0.58 Units on a scale Standard Deviation 2.343	-1.15 Units on a scale Standard Deviation 2.323

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

The WPAI-SHP is a 6-item questionnaire used to assess the degree to which a specified health problem (here "AS") affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent work time missed due to AS for each study arm are reported.

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Percent Work Time Missed Due to AS (Assessed by Work Productivity and Activity Impairment Questionnaire - Specific Health Problem [WPAI-SHP]) Through Week 24 Change at Week 16	-3.72 units on a scale Standard Deviation 26.092	-2.05 units on a scale Standard Deviation 26.625	-2.06 units on a scale Standard Deviation 26.486
Change From Baseline in Percent Work Time Missed Due to AS (Assessed by Work Productivity and Activity Impairment Questionnaire - Specific Health Problem [WPAI-SHP]) Through Week 24 Change at Week 24	-7.37 units on a scale Standard Deviation 16.925	-4.38 units on a scale Standard Deviation 22.562	-7.07 units on a scale Standard Deviation 22.081

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem ("AS") affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent impairment while working due to AS for each study arm are reported.

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Percent Impairment While Working Due to AS (Assessed by WPAI-SHP) Through Week 24 Change at Week 16	-16.87 units on a scale Standard Deviation 25.359	-5.97 units on a scale Standard Deviation 21.607	-17.57 units on a scale Standard Deviation 20.032
Change From Baseline in Percent Impairment While Working Due to AS (Assessed by WPAI-SHP) Through Week 24 Change at Week 24	-22.00 units on a scale Standard Deviation 21.892	-13.57 units on a scale Standard Deviation 22.758	-19.68 units on a scale Standard Deviation 22.973

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

WPAI-SHP is 6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. Questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent overall work impairment due to AS for each study arm are reported.

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Percent Overall Work Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24 Change at Week 16	-16.03 units on a scale Standard Deviation 26.281	-6.64 units on a scale Standard Deviation 23.976	-17.48 units on a scale Standard Deviation 20.811
Change From Baseline in Percent Overall Work Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24 Change at Week 24	-21.98 units on a scale Standard Deviation 21.042	-14.64 units on a scale Standard Deviation 24.300	-20.54 units on a scale Standard Deviation 24.271

SECONDARY outcome

Timeframe: Baseline, Week 16 and 24

Population: FAS included participants who were randomized and received at least one administration of study agent. Participants analyzed based on randomized treatment group they were assigned to regardless of treatment received. Here 'n' signifies number of participants who were analyzed at each specified timepoint, for each arm, respectively.

WPAI-SHP is6-item questionnaire used to assess the degree to which a specified health problem (AS) affected work attendance, work productivity and productivity in non-work regular activities. Patients are asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. change from baseline in percent non-work activity impairment due to AS for each study arm are reported.

Outcome measures

Outcome measures
Measure	Placebo n=116 Participants Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Ustekinumab 45 Milligram (mg) n=116 Participants Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.	Ustekinumab 90 mg n=114 Participants Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52. At Week 24, participants received placebo SC injection to maintain the blind.
Change From Baseline in Percent Non-work Activity Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24 Change at Week 16	-14.74 units on a scale Standard Deviation 23.013	-13.45 units on a scale Standard Deviation 21.833	-17.52 units on a scale Standard Deviation 22.101
Change From Baseline in Percent Non-work Activity Impairment Due to AS (Assessed by WPAI-SHP) Through Week 24 Change at Week 24	-21.72 units on a scale Standard Deviation 23.288	-21.49 units on a scale Standard Deviation 23.825	-21.73 units on a scale Standard Deviation 22.339

Adverse Events

Placebo Only

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo to Golimumab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo to Ustekinumab 45mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo to Ustekinumab 90mg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Ustekinumab 45 mg Only

Serious events: 3 serious events

Other events: 24 other events

Deaths: 0 deaths

Ustekinumab 45mg to Golimumab

Serious events: 3 serious events

Other events: 7 other events

Deaths: 1 deaths

Ustekinumab 90 mg Only

Serious events: 2 serious events

Other events: 26 other events

Deaths: 0 deaths

Ustekinumab 90mg to Golimumab

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Only n=116 participants at risk Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Placebo to Golimumab n=26 participants at risk Participants randomized to placebo SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.	Placebo to Ustekinumab 45mg n=44 participants at risk Participants randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward.	Placebo to Ustekinumab 90mg n=43 participants at risk Participants randomized to placebo SC and then rerandomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward.	Ustekinumab 45 mg Only n=116 participants at risk Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.	Ustekinumab 45mg to Golimumab n=21 participants at risk Participants randomized to ustekinumab 45 mg SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.	Ustekinumab 90 mg Only n=114 participants at risk Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.	Ustekinumab 90mg to Golimumab n=14 participants at risk Participants randomized to ustekinumab 90 mg SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.
Eye disorders Ocular Hypertension	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Eye disorders Uveitis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	4.8% 1/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Hepatobiliary disorders Cholelithiasis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Infections and infestations Appendicitis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Infections and infestations Cellulitis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.88% 1/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Injury, poisoning and procedural complications Back Injury	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	4.8% 1/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Injury, poisoning and procedural complications Concussion	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Injury, poisoning and procedural complications Muscle Strain	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Injury, poisoning and procedural complications Subdural Haematoma	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.88% 1/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Musculoskeletal and connective tissue disorders Intervertebral Disc Disorder	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.86% 1/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.86% 1/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Salivary Gland Neoplasm	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	4.8% 1/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Nervous system disorders Facial Paralysis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.86% 1/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Nervous system disorders Ischaemic Stroke	0.86% 1/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Nervous system disorders Vertebrobasilar Insufficiency	0.86% 1/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Renal and urinary disorders Calculus Urinary	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.

Other adverse events

Other adverse events
Measure	Placebo Only n=116 participants at risk Participants received placebo subcutaneous (SC) injection at Weeks 0, 4, and 16. At Week 16, participants who met EE criteria were administered open-label golimumab 50 milligram (mg) SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52. At Week 24 all participants (with the exception of participants who qualified for early escape \[EE\]) were re-randomized to receive either ustekinumab 45 or 90 milligram (mg) SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing through Week 100.	Placebo to Golimumab n=26 participants at risk Participants randomized to placebo SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.	Placebo to Ustekinumab 45mg n=44 participants at risk Participants randomized to placebo SC and then rerandomized to receive ustekinumab 45 mg at Week 24; adverse events are counted from crossover onward.	Placebo to Ustekinumab 90mg n=43 participants at risk Participants randomized to placebo SC and then rerandomized to receive ustekinumab 90 mg at Week 24; adverse events are counted from crossover onward.	Ustekinumab 45 mg Only n=116 participants at risk Participants received ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by every 12 week dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.	Ustekinumab 45mg to Golimumab n=21 participants at risk Participants randomized to ustekinumab 45 mg SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.	Ustekinumab 90 mg Only n=114 participants at risk Participants received ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing through Week 100. At Week 16, participants who met EE criteria were administered open-label golimumab 50 mg SC administrations at Week 16 and q4w thereafter through Week 52.	Ustekinumab 90mg to Golimumab n=14 participants at risk Participants randomized to ustekinumab 90 mg SC who met early escape criteria and received golimumab 50 mg from Week 16; adverse events are counted from early escape onward.
Metabolism and nutrition disorders Fasciitis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	7.1% 1/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Infections and infestations Acute Sinusitis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.88% 1/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	7.1% 1/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Infections and infestations Influenza	0.86% 1/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	1.7% 2/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	7.1% 1/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Infections and infestations Respiratory Tract Infection Viral	1.7% 2/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	5.3% 6/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Infections and infestations Upper Respiratory Tract Infection	1.7% 2/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	3.8% 1/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.6% 3/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	9.5% 2/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	3.5% 4/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Infections and infestations Viral Upper Respiratory Tract Infection	4.3% 5/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	3.8% 1/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	7.8% 9/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	9.5% 2/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	9.6% 11/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Investigations Alanine Aminotransferase Increased	5.2% 6/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	7.7% 2/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	6.9% 8/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	9.5% 2/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	5.3% 6/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Investigations Aspartate Aminotransferase Increased	2.6% 3/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	7.7% 2/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	6.9% 8/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	14.3% 3/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.6% 3/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.6% 3/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.88% 1/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	7.1% 1/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.
Metabolism and nutrition disorders Ankylosing Spondylitis	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/26 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	2.3% 1/44 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/43 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/116 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/21 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	0.00% 0/114 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.	7.1% 1/14 • Approximately 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. Adverse events were reported according to the treatment they actually received, regardless of the treatments they are randomized to.

Additional Information

SENIOR DIRECTOR CLINICAL DEVELOPMENT

Johnson&Johnson

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