Trial Outcomes & Findings for Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038) (NCT NCT03253796)

Last Updated: 2023-07-28

Results Overview

Disease flare is defined as an Ankylosing Spondylitis Disease Activity Score (ASDAS) at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1 relative to baseline prior to the first dose of double-blind treatment in Period 2. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually scored on a numeric scale of 0 to 10, with 0 being low activity/impact and 10 being high activity/impact. The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

323 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2023-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Open-Label Run-In Golimumab QM Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.	Golimumab QM (Full Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Period 1: Run-In STARTED	323	0	0	0	0
Period 1: Run-In COMPLETED	207	0	0	0	0
Period 1: Run-In NOT COMPLETED	116	0	0	0	0
Period 2: Withdrawal vs Continued Tx STARTED	0	63	64	62	0
Period 2: Withdrawal vs Continued Tx COMPLETED	0	53	43	21	0
Period 2: Withdrawal vs Continued Tx NOT COMPLETED	0	10	21	41	0
Period 2: Open-Label Retreatment STARTED	0	0	0	0	63
Period 2: Open-Label Retreatment COMPLETED	0	0	0	0	58
Period 2: Open-Label Retreatment NOT COMPLETED	0	0	0	0	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-Label Run-In Golimumab QM Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.	Golimumab QM (Full Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Period 1: Run-In Adverse Event	4	0	0	0	0
Period 1: Run-In Lack of Efficacy	1	0	0	0	0
Period 1: Run-In Lack of Qualifying Event	98	0	0	0	0
Period 1: Run-In Protocol Violation	5	0	0	0	0
Period 1: Run-In Withdrawal by Subject	8	0	0	0	0
Period 2: Withdrawal vs Continued Tx Adverse Event	0	0	2	0	0
Period 2: Withdrawal vs Continued Tx Physician Decision	0	0	1	0	0
Period 2: Withdrawal vs Continued Tx Withdrawal by Subject	0	0	2	3	0
Period 2: Withdrawal vs Continued Tx Did not attain inactive disease in Period 1	0	0	1	0	0
Period 2: Withdrawal vs Continued Tx Disease Flare, transitioned to Open-label retreatment	0	10	15	38	0
Period 2: Open-Label Retreatment Withdrawal by Subject	0	0	0	0	5

Baseline Characteristics

The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-Label Run-In Golimumab QM n=323 Participants Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=64 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment n=63 Participants Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.	Total n=575 Participants Total of all reporting groups
Age, Continuous Period 1: Open-Label Run-In	32.5 Years STANDARD_DEVIATION 7.2 • n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	32.5 Years STANDARD_DEVIATION 7.2 • n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Age, Continuous Period 2: Withdrawal vs Continued Tx	—	31.4 Years STANDARD_DEVIATION 8.0 • n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	30.8 Years STANDARD_DEVIATION 6.7 • n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	32.9 Years STANDARD_DEVIATION 6.8 • n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	31.7 Years STANDARD_DEVIATION 7.2 • n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Withdrawal vs Continued Tx · American Indian or Alaska Native	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	0 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Withdrawal vs Continued Tx · Asian	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	0 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Age, Continuous Period 2: Open-Label Retreatment	—	—	—	—	33.4 Years STANDARD_DEVIATION 6.7 • n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	33.4 Years STANDARD_DEVIATION 6.7 • n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Sex: Female, Male Period 1: Open-Label Run-In · Female	109 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	109 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Sex: Female, Male Period 1: Open-Label Run-In · Male	214 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	214 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Sex: Female, Male Period 2: Withdrawal vs Continued Tx · Female	—	19 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	21 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	16 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	56 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Sex: Female, Male Period 2: Withdrawal vs Continued Tx · Male	—	44 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	43 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	46 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	133 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Sex: Female, Male Period 2: Open-Label Retreatment · Female	—	—	—	—	20 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	20 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Sex: Female, Male Period 2: Open-Label Retreatment · Male	—	—	—	—	43 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	43 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 1: Open-Label Run-In · Hispanic or Latino	2 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	2 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 1: Open-Label Run-In · Not Hispanic or Latino	321 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	321 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 1: Open-Label Run-In · Unknown or Not Reported	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 2: Withdrawal vs Continued Tx · Hispanic or Latino	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	0 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 2: Withdrawal vs Continued Tx · Not Hispanic or Latino	—	63 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	64 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	62 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	189 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 2: Withdrawal vs Continued Tx · Unknown or Not Reported	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	0 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 2: Open-Label Retreatment · Hispanic or Latino	—	—	—	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 2: Open-Label Retreatment · Not Hispanic or Latino	—	—	—	—	63 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	63 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Ethnicity (NIH/OMB) Period 2: Open-Label Retreatment · Unknown or Not Reported	—	—	—	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 1: Open-Label Run-In · American Indian or Alaska Native	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 1: Open-Label Run-In · Asian	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 1: Open-Label Run-In · Native Hawaiian or Other Pacific Islander	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 1: Open-Label Run-In · Black or African American	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 1: Open-Label Run-In · White	323 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	323 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 1: Open-Label Run-In · More than one race	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 1: Open-Label Run-In · Unknown or Not Reported	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	0 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Withdrawal vs Continued Tx · Native Hawaiian or Other Pacific Islander	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	0 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Withdrawal vs Continued Tx · Black or African American	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	0 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Withdrawal vs Continued Tx · White	—	63 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	64 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	62 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	189 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Withdrawal vs Continued Tx · More than one race	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	0 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Withdrawal vs Continued Tx · Unknown or Not Reported	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	0 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Open-Label Retreatment · American Indian or Alaska Native	—	—	—	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Open-Label Retreatment · Asian	—	—	—	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Open-Label Retreatment · Native Hawaiian or Other Pacific Islander	—	—	—	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Open-Label Retreatment · Black or African American	—	—	—	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Open-Label Retreatment · White	—	—	—	—	63 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	63 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Open-Label Retreatment · More than one race	—	—	—	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
Race (NIH/OMB) Period 2: Open-Label Retreatment · Unknown or Not Reported	—	—	—	—	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	0 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
C-Reactive Protein (CRP) Category at Enrollment Period 1: Open-Label Run-In · > 6 mg/L	196 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	196 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
C-Reactive Protein (CRP) Category at Enrollment Period 1: Open-Label Run-In · ≤ 6 mg/L	127 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	—	—	—	127 Participants n=323 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
C-Reactive Protein (CRP) Category at Enrollment Period 2: Withdrawal vs Continued Tx · > 6 mg/L	—	40 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	40 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	39 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	119 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
C-Reactive Protein (CRP) Category at Enrollment Period 2: Withdrawal vs Continued Tx · ≤ 6 mg/L	—	23 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	24 Participants n=64 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	23 Participants n=62 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	—	70 Participants n=189 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
C-Reactive Protein (CRP) Category at Enrollment Period 2: Open-Label Retreatment · > 6 mg/L	—	—	—	—	38 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	38 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2
C-Reactive Protein (CRP) Category at Enrollment Period 2: Open-Label Retreatment · ≤ 6 mg/L	—	—	—	—	25 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2	25 Participants n=63 Participants • The first row represents Period 1, the second row represents the double-blind portion of Period 2, and the third row represents open-label retreatment in Period 2

PRIMARY outcome

Timeframe: Up to 12 months

Population: The analysis population consists of all participants who attained inactive disease in Period 1, were randomized in Period 2, and received at least one dose of double-blind study intervention.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Without a Disease Activity Flare During Period 2	84.1 Percentage of participants	68.3 Percentage of participants	33.9 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 3 months following start of retreatment

Population: The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to the reduced-treatment regimen or placebo in Period 2, received at least one dose of double-blind study intervention, and experienced a disease flare during Period 2. Per protocol, participants randomized to the Full Treatment Regimen were not included in this analysis.

Clinical response is defined as Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score improvement of ≥2.0 or ≥50% improvement within 3 months of the start of retreatment, relative to the mean of the two consecutive BASDAI scores that defined the flare. Sustained clinical response refers to participants who attained clinical response and maintained BASDAI criteria throughout the 3-month retreatment period. Response data was collected throughout Period 2 (12 months) and censored to include only the first 3 months after retreatment for a disease flare. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness \[0 (zero) to 10 (2 or more hours)\]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=53 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment Sustained clinical response	71.7 Percentage of participants Interval 57.7 to 83.2	—	—	—
Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment Within 1 month of retreatment	90.6 Percentage of participants Interval 79.3 to 96.9	—	—	—
Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment Within 2 months of retreatment	96.2 Percentage of participants Interval 87.0 to 99.5	—	—	—
Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment Within 3 months of retreatment	96.2 Percentage of participants Interval 87.0 to 99.5	—	—	—

SECONDARY outcome

Timeframe: Month 3, Month 6, Month 9, and Month 12

The Kaplan-Meier analysis of time to first "flare" in Period 2 is represented by the percentage of participants who experienced a disease flare relative to baseline prior to the first dose of double-blind treatment in Period 2. Disease flare is defined as ASDAS at two consecutive visits that both show either absolute score ≥2.1 or a post-withdrawal increase of ≥1.1.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Time to First Disease Flare Month 12	15.9 Percentage of participants	23.8 Percentage of participants	61.3 Percentage of participants	—
Time to First Disease Flare Month 3	14.3 Percentage of participants	7.9 Percentage of participants	41.9 Percentage of participants	—
Time to First Disease Flare Month 6	14.3 Percentage of participants	17.5 Percentage of participants	58.1 Percentage of participants	—
Time to First Disease Flare Month 9	14.3 Percentage of participants	20.6 Percentage of participants	61.3 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 12 months

ASAS20 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 ≥1.0 in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline for ASAS20 analysis is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment)	9.5 Percentage of participants	3.2 Percentage of participants	0.0 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 12 months

ASAS20 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 ≥1.0 in at least 3 of 4 domains, and 2) Absence of deterioration from Baseline (defined as a ≥20% worsening and an absolute worsening of ≥1.0) in the potential remaining domain. Baseline for ASAS20 analysis is defined as the last ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=53 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment)	94.3 Percentage of participants Interval 84.3 to 98.8	—	—	—

SECONDARY outcome

Timeframe: Up to 12 months

ASAS40 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 ≥2.0 in at least 3 of 4 domains, and 2) No deterioration from Baseline in the potential remaining domain. Baseline for ASAS40 analysis is defined as the last ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment)	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 12 months

ASAS40 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 ≥2.0 in at least 3 of 4 domains, and 2) No deterioration from Baseline in the potential remaining domain. Baseline for ASAS40 analysis is defined as the last ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: the Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=53 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment)	90.6 Percentage of participants Interval 79.3 to 96.9	—	—	—

SECONDARY outcome

Timeframe: Up to 12 months

ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of double-blind treatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment)	85.7 Percentage of participants	85.7 Percentage of participants	71.0 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 12 months

ASAS partial remission is defined as a score of ≤2 in all 4 ASAS domains. Baseline for this analysis is defined as the ASAS score prior to the first dose of open-label retreatment in Period 2. The ASAS consists of 4 domains: Patient Global Disease Assessment (PGDn), total back pain, function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]), and morning stiffness (mean of questions 5 and 6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Each domain is measured on a 10-point numeric scale from 0=no disease symptoms/impact to 10=extreme disease symptoms/impact, with a higher score indicating more severe impairment.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=53 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment)	92.5 Percentage of participants Interval 81.8 to 97.9	—	—	—

SECONDARY outcome

Timeframe: Up to 12 months

BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of double-blind treatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness \[0 (zero) to 10 (2 or more hours)\]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)	49.2 Percentage of participants	30.2 Percentage of participants	24.2 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 12 months

BASDAI50 is defined as ≥50% improvement from baseline in the Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI) score. Baseline for BASDAI50 analysis is defined as the last BASDAI score prior to the first dose of open-label retreatment in Period 2. The BASDAI is a summary of 6 participant-assessed measures rated on scales of 0 (none) to 10 (very severe): fatigue, spinal pain, joint pain/swelling, tenderness, morning stiffness, and duration of morning stiffness \[0 (zero) to 10 (2 or more hours)\]. The BASDAI score is the mean of responses to the 6 questions with a minimum of 0 and a maximum of 10. A higher score indicates greater disease activity.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=53 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)	98.1 Percentage of participants Interval 89.9 to 100.0	—	—	—

SECONDARY outcome

Timeframe: Up to 12 months

Inactive disease status is defined as an ASDAS score \<1.3. The ASDAS is a composite index assessing disease activity in axial spondyloarthropathies that consists of 4 self-assessed parameters and 1 laboratory parameter. The self-assessed parameters of back pain, duration of morning stiffness, Patient Global Disease Assessment (PGDn), and peripheral pain/swelling are individually scored on a numeric scale of 0 to 10, with 0 being low activity/impact and 10 being high activity/impact. The self-assessed criteria and the laboratory value of CRP are combined to provide the total ASDAS score, which has a lower limit of 0.6 and no defined upper limit. A higher score indicates greater disease activity.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)	85.7 Percentage of participants	84.1 Percentage of participants	61.3 Percentage of participants	—

SECONDARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=53 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment)	90.6 Percentage of participants Interval 79.3 to 96.9	—	—	—

SECONDARY outcome

Timeframe: Up to approximately 15 months

Population: The analysis population consists of all participants who received at least one dose of study intervention in Period 2.

This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE. The analysis includes AEs that occurred through 90 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=64 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment n=63 Participants Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2	46.0 Percentage of participants	46.9 Percentage of participants	32.3 Percentage of participants	41.3 Percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 12 months

Population: The analysis population consists of all participants who received at least one dose of study intervention in Period 2.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=64 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 Participants Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment n=63 Participants Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2	0.0 Percentage of participants	4.7 Percentage of participants	1.6 Percentage of participants	0.0 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=125 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Withdrawal Regimens)	84.1 Percentage of participants	51.2 Percentage of participants	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 12 months

Population: The analysis population consists of all participants who attained inactive disease in Period 1, were randomized to receive golimumab in Period 2, and received at least one dose of double-blind study intervention.

Outcome measures

Outcome measures
Measure	Golimumab QM (Full Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=63 Participants Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Reduced Treatment Regimen)	84.1 Percentage of participants	68.3 Percentage of participants	—	—

Adverse Events

Open-Label Run-In Golimumab QM

Serious events: 7 serious events

Other events: 79 other events

Deaths: 0 deaths

Golimumab QM (Full Treatment Regimen)

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Golimumab Q2M (Reduced Treatment Regimen)

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo (Treatment Withdrawal Regimen)

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Open-Label Retreatment

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open-Label Run-In Golimumab QM n=323 participants at risk Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.	Golimumab QM (Full Treatment Regimen) n=63 participants at risk Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=64 participants at risk Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 participants at risk Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment n=63 participants at risk Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Hepatobiliary disorders Cholecystitis chronic	0.31% 1/323 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/64 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Infections and infestations Pilonidal cyst	0.31% 1/323 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/64 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Infections and infestations Pyelonephritis acute	0.00% 0/323 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	1.6% 1/64 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Infections and infestations Sinusitis bacterial	0.31% 1/323 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/64 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Joint injury	0.00% 0/323 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	1.6% 1/63 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/64 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/323 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/64 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	1.6% 1/62 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Arthritis	0.31% 1/323 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/64 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Exostosis	0.31% 1/323 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/64 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Joint instability	0.31% 1/323 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/64 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Renal and urinary disorders Renal colic	0.31% 1/323 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	1.6% 1/64 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/62 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	0.00% 0/63 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.

Other adverse events

Other adverse events
Measure	Open-Label Run-In Golimumab QM n=323 participants at risk Participants were treated with open-label subcutaneous (SC) injections of 50 mg golimumab once a month (QM) for up to 10 months. Participants with a body weight greater than 100 kg may have received 100 mg injections of golimumab at the discretion of the investigator.	Golimumab QM (Full Treatment Regimen) n=63 participants at risk Participants were treated with double-blinded SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Golimumab Q2M (Reduced Treatment Regimen) n=64 participants at risk Participants were treated with double-blinded SC injections of 50 mg golimumab every other month (Q2M) alternating with matching placebo to golimumab every other month for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Placebo (Treatment Withdrawal Regimen) n=62 participants at risk Participants were treated with double-blinded SC injections of placebo for up to 12 months. Participants who experienced a disease flare during double-blinded treatment in Period 2 discontinued blinded treatment and were retreated with open-label golimumab.	Open-Label Retreatment n=63 participants at risk Participants who experienced a disease flare were treated with open-label SC injections of 50 mg golimumab QM for up to 12 months. Participants with a body weight greater than 100 kg who had received 100 mg injections of golimumab in Period 1 continued to receive this dosage for the duration of the study.
Infections and infestations Nasopharyngitis	11.1% 36/323 • Number of events 39 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	9.5% 6/63 • Number of events 7 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	9.4% 6/64 • Number of events 6 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	4.8% 3/62 • Number of events 4 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	6.3% 4/63 • Number of events 4 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Infections and infestations Pharyngitis	3.7% 12/323 • Number of events 14 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	3.2% 2/63 • Number of events 2 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	9.4% 6/64 • Number of events 9 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	4.8% 3/62 • Number of events 4 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	1.6% 1/63 • Number of events 1 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Infections and infestations Upper respiratory tract infection	5.0% 16/323 • Number of events 24 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	3.2% 2/63 • Number of events 5 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	4.7% 3/64 • Number of events 3 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	3.2% 2/62 • Number of events 3 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	7.9% 5/63 • Number of events 5 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.
Nervous system disorders Headache	7.4% 24/323 • Number of events 39 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	6.3% 4/63 • Number of events 8 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	3.1% 2/64 • Number of events 3 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	6.5% 4/62 • Number of events 5 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.	1.6% 1/63 • Number of events 2 • Up to 10 months in Period 1 (Open-Label Run-in) and up to 15 months in Period 2 (Withdrawal vs Continued Treatment) for a total of up to 25 months. The safety analysis population includes all participants who received at least one dose of study intervention.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
Publication restrictions are in place

Restriction type: OTHER