GO-AHEAD: Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01453725
• Collaborator: Johnson & Johnson (Industry)
• Enrollment: 198
• Arms: 2
• Actual Duration (Months): 35.1

Study Details

Study Description

Brief Summary

This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.

Condition or Disease	Intervention/Treatment	Phase
Spondylitis, Ankylosing	Biological: Golimumab; Biological: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Protocol No. P07642, Also Known as MK-8259-006-02).
• Actual Study Start Date: Feb 13, 2012
• Actual Primary Completion Date: Mar 11, 2014
• Actual Study Completion Date: Jan 15, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Golimumab→Golimumab In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	Biological: Golimumab; Golimumab 50 mg SC injection every 4 weeks
Placebo Comparator: Placebo→Golimumab In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)	Biological: Golimumab; Golimumab 50 mg SC injection every 4 weeks; Biological: Placebo; Placebo SC injection every 4 weeks

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16 [Week 16]

   The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.

2. Percentage of Participants Who Experienced at Least One Adverse Event (AE) [Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)]

   An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.

3. Percentage of Participants Who Discontinued Study Drug Due to an AE [Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2]

   An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.

Secondary Outcome Measures

1. Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16 [Week 16]

   The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.

2. Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16 [Week 16]

   The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.

3. Percentage of Participants Achieving ASAS Partial Remission at Week 16 [Week 16]

   ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.

4. Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16 [Baseline and Week 16]

   Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration

• Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs

• Females of child-bearing potential must use contraception

• No history of untreated latent or active tuberculosis

Exclusion Criteria:

• Fulfillment of modified New York criteria for ankylosing spondylitis

• Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological agents

• Any systemic inflammatory condition other than spondyloarthritis

• Serious infection within 2 months

• Any known malignancy or a history of malignancy within the previous 5 years

• Has or had a substance abuse (drug or alcohol) problem within the previous 2 years

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Merck Sharp & Dohme LLC
• Johnson & Johnson

Investigators

• Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT01453725
• Other Study ID Numbers: P07642; MK-8259-006; 2011-000311-34
• First Posted: Oct 18, 2011
• Last Update Posted: Feb 6, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Golimumab

Study Results

Participant Flow

Pre-assignment Detail	These data are for Parts 1 and 2 of the study.

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Period Title: Overall Study
STARTED	98	100
COMPLETED	85	89
NOT COMPLETED	13	11

Baseline Characteristics

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab	Total
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)	Total of all reporting groups
Overall Participants	98	100	198
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	30.7 (7.1)	31.7 (7.2)	31.2 (7.2)
Sex: Female, Male (Count of Participants)
Female	37 37.8%	48 48%	85 42.9%
Male	61 62.2%	52 52%	113 57.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
Description	The ASAS consists of 4 domains: participant global assessment, total back pain, function (Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Each domain is measured on a 100-mm visual analog scale (VAS) from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 20 is a 20% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=20% from Baseline and an absolute improvement from Baseline of >=10 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=20% worsening and an absolute worsening of >=10 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 20 were calculated.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The Full-Analysis-Set (FAS) population consisted of all randomized participants who received at least one dose of study drug in Part 1.

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Measure Participants	97	100
Number [Percentage of Participants]	71.1 72.6%	40.0 40%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab→Golimumab, Placebo→Golimumab
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Stratification factors: Baseline evidence of sacroiliitis on magnetic resonance imaging (MRI) and Screening C-reactive protein (CRP) level
	Method	Stratified Miettinen and Nurminen Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent vs Placebo
	Estimated Value	31.2
	Confidence Interval	(2-Sided) 95%; 17.5 to 43.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
Description	The ASAS consists of 4 domains: participant global assessment, total back pain, function (BASFI), and inflammation (mean of questions 5 and 6 of BASDAI). Each domain is measured on a 100-mm VAS from 0 mm=the very best situation to 100 mm=the very worst situation, with a higher score indicating more severe impairment. ASAS 40 is a 40% improvement in response (per the Assessment in Ankylosing Spondylitis International Working Group) defined as meeting 2 criteria: 1) An improvement of >=40% from Baseline and an absolute improvement from Baseline of >=20 mm in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a >=0% worsening and an absolute worsening of >=0 mm) in the potential remaining domain. The percentages of participants who achieved ASAS 40 were calculated.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Measure Participants	97	100
Number [Percentage of Participants]	56.7 57.9%	23.0 23%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab→Golimumab, Placebo→Golimumab
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level
	Method	Stratified Miettinen and Nurminen Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent vs Placebo
	Estimated Value	33.8
	Confidence Interval	(2-Sided) 95%; 20.4 to 46.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16
Description	The BASDAI is a summary of 6 participant-assessed 100-mm VAS for a) Fatigue, b) Spinal pain (overall), c) Peripheral arthritis, d) Enthesitis, e) Qualitative morning stiffness (intensity) and f) Quantitative morning stiffness (duration). Each VAS is measured as 0=none to 100=very severe, with a higher score indicating more severe symptoms. The BASDAI score is calculated as 0.2 time (a+b+c+d+[0.5 times e+f]) and can range from 0 to 100. The BASDAI 50 is defined as improvement by at least 50% from Baseline in the BASDAI score. The percentages of participants who achieved BASDAI 50 were calculated.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1 and had a Baseline BASDAI assessement.

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Measure Participants	97	100
Number [Percentage of Participants]	57.7 58.9%	30.0 30%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab→Golimumab, Placebo→Golimumab
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments	Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level
	Method	Stratified Miettinen and Nurminen Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent vs Placebo
	Estimated Value	28.0
	Confidence Interval	(2-Sided) 95%; 14.4 to 40.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants Achieving ASAS Partial Remission at Week 16
Description	ASAS partial remission was defined as a VAS score of less than 20 mm in each of the 4 domains of ASAS 20: participant global assessment, pain (total back pain), function and inflammation. The percentages of participants who achieved ASAS partial remission were calculated.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1.

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Measure Participants	97	100
Number [Percentage of Participants]	33.0 33.7%	18.0 18%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab→Golimumab, Placebo→Golimumab
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0136
	Comments	Stratification factors: Baseline evidence of sacroiliitis on MRI and Screening CRP level
	Method	Stratified Miettinen and Nurminen Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Percent vs Placebo
	Estimated Value	15.2
	Confidence Interval	(2-Sided) 95%; 3.2 to 27.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16
Description	Participants underwent MRI of the SI joints, without contrast, at Screening and Week 16 to assess the presence or absence of active inflammation of the SI joints. Scoring was based on 6 consecutive MRI slices through the SI joint. Each slice was divided into 4 quadrants. Each of the 48 quadrants was scored with respect to the presence of inflammation (0=no, 1=yes), yielding a maximum score of 48. Each slice was also assessed for the presence of a lesion exhibiting either intense signal or a depth >=1 cm anywhere within the SI joint of the 6 slices (0=no, 1=yes), yielding a maximum score of 24. Total SI joint scores could range from 0 to 72, with a higher score indicating more signs of disease.
Time Frame	Baseline and Week 16

Outcome Measure Data

Analysis Population Description

The FAS population consisted of all randomized participants who received at least one dose of study drug in Part 1, who completed Part 1, and who had Baseline and Week 16 MRI SI joint measurements.

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Measure Participants	74	87
Baseline Score	9.87 (11.822)	12.66 (15.619)
Change from Baseline at Week 16	-5.25 (7.708)	-0.95 (8.533)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab→Golimumab, Placebo→Golimumab
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mann-Whitney Test
	Comments

6. Primary Outcome

Title	Percentage of Participants Who Experienced at Least One Adverse Event (AE)
Description	An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who experienced at least one AE were calculated for each part of the study.
Time Frame	Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)

Outcome Measure Data

Analysis Population Description

The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Measure Participants	97	100
Part 1 (Up to 16 weeks) (n=97, 100)	41.2 42%	47.0 47%
Part 2 (Up to 60 weeks) (n=93, 96)	41.9 42.8%	54.2 54.2%

7. Primary Outcome

Title	Percentage of Participants Who Discontinued Study Drug Due to an AE
Description	An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug. The percentages of participants who discontinued study drug due to an AE were calculated for each part of the study. Participants may have discontinued study drug without discontinuing from the study.
Time Frame	Up to 16 weeks for Part 1; Week 16 through up to 48 weeks for Part 2

Outcome Measure Data

Analysis Population Description

The APaT population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.

Arm/Group Title	Golimumab→Golimumab	Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)	In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
Measure Participants	97	100
Part 1 (Up to 16 weeks) (n=97, 100)	2.1 2.1%	1.0 1%
Part 2 (Up to 52 weeks) (n=93, 96)	1.1 1.1%	2.1 2.1%

Adverse Events

Time Frame	Up to 16 weeks for Part 1: Week 16 through up to 60 weeks for Part 2 (Up to 12 weeks after last dose of study drug)
Adverse Event Reporting Description	The All-Participants-as-Treated (APaT) population of this study consisted of all randomized participants who received at least one dose of study drug. These data are for Parts 1 and 2 of the study.
Arm/Group Title	Part 1: Golimumab→Golimumab		Part 1: Placebo→Golimumab		Part 2: Golimumab→Golimumab		Part 2: Placebo→Golimumab
Arm/Group Description	In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)		In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)		In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)		In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
All Cause Mortality
	Part 1: Golimumab→Golimumab		Part 1: Placebo→Golimumab		Part 2: Golimumab→Golimumab		Part 2: Placebo→Golimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Part 1: Golimumab→Golimumab		Part 1: Placebo→Golimumab		Part 2: Golimumab→Golimumab		Part 2: Placebo→Golimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/97 (1%)		2/100 (2%)		2/93 (2.2%)		3/96 (3.1%)
Gastrointestinal disorders
Duodenitis	0/97 (0%)	0	0/100 (0%)	0	1/93 (1.1%)	1	0/96 (0%)	0
Hepatobiliary disorders
Cholelithiasis	0/97 (0%)	0	1/100 (1%)	1	0/93 (0%)	0	0/96 (0%)	0
Infections and infestations
Bacterial infection	0/97 (0%)	0	0/100 (0%)	0	1/93 (1.1%)	1	0/96 (0%)	0
Staphylococcal infection	0/97 (0%)	0	0/100 (0%)	0	0/93 (0%)	0	1/96 (1%)	1
Musculoskeletal and connective tissue disorders
Back pain	0/97 (0%)	0	1/100 (1%)	1	0/93 (0%)	0	0/96 (0%)	0
Nervous system disorders
Migraine	0/97 (0%)	0	0/100 (0%)	0	0/93 (0%)	0	1/96 (1%)	1
Pregnancy, puerperium and perinatal conditions
Foetal death	1/97 (1%)	1	0/100 (0%)	0	0/93 (0%)	0	0/96 (0%)	0
Reproductive system and breast disorders
Uterine polyp	0/97 (0%)	0	0/100 (0%)	0	0/93 (0%)	0	1/96 (1%)	1
Other (Not Including Serious) Adverse Events
	Part 1: Golimumab→Golimumab		Part 1: Placebo→Golimumab		Part 2: Golimumab→Golimumab		Part 2: Placebo→Golimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/97 (17.5%)		21/100 (21%)		13/93 (14%)		27/96 (28.1%)
Gastrointestinal disorders
Nausea	0/97 (0%)	0	6/100 (6%)	8	0/93 (0%)	0	0/96 (0%)	0
Diarrhoea	0/97 (0%)	0	0/100 (0%)	0	1/93 (1.1%)	1	5/96 (5.2%)	5
Infections and infestations
Nasopharyngitis	9/97 (9.3%)	11	9/100 (9%)	11	5/93 (5.4%)	5	10/96 (10.4%)	12
Influenza	0/97 (0%)	0	0/100 (0%)	0	2/93 (2.2%)	3	7/96 (7.3%)	7
Upper respiratory tract infection	0/97 (0%)	0	0/100 (0%)	0	4/93 (4.3%)	5	6/96 (6.3%)	9
Nervous system disorders
Headache	7/97 (7.2%)	8	6/100 (6%)	11	6/93 (6.5%)	11	8/96 (8.3%)	26
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	5/97 (5.2%)	5	4/100 (4%)	4	0/93 (0%)	0	0/96 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The investigator agrees not to publish or publicly present any interim results of the study without the prior written consent of the sponsor. The investigator further agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication (including slides and texts of oral or other public presentations and texts of any transmission through any electronic media) that report any results of the trial.