Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)

• Sponsor: Merck Sharp & Dohme LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03253796
• Collaborator: (none)
• Enrollment: 323
• Locations: 71
• Arms: 4
• Actual Duration (Months): 40.3
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.

Condition or Disease	Intervention/Treatment	Phase
Spondyloarthritis	Biological: Golimumab; Biological: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 323 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: To evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (either every month [QM] or every 2 months [Q2M]) on the incidence of a "flare" during up to 12 months in Period 2 (blinded therapy).To evaluate the effect of treatment withdrawal compared to continued treatment with golimumab (either every month [QM] or every 2 months [Q2M]) on the incidence of a "flare" during up to 12 months in Period 2 (blinded therapy).
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase-IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Evaluate the Efficacy and Safety of Golimumab (MK-8259 [SCH 900259]) After Treatment Withdrawal, Compared With Continued Treatment (Either Full- or Reduced-Treatment Regimen), In Subjects With Non-Radiographic Axial Spondyloarthritis
• Actual Study Start Date: Nov 7, 2017
• Actual Primary Completion Date: Mar 17, 2021
• Actual Study Completion Date: Mar 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GLM SC QM (Full Treatment Regimen) Period 1: participants are treated with open-label (OL) GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded SC GLM QM for up to 12 months	Biological: Golimumab; Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.; Other Names: MK-8259 Simponi®
Experimental: GLM SC Q2M (Reduced Treatment Regimen) Period 1: participants are treated with OL GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded GLM SC every other month alternating with matching placebo to GLM every other month for up to 12 months	Biological: Golimumab; Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.; Other Names: MK-8259 Simponi® ; Biological: Placebo; Injections of matching placebo for golimumab.
Placebo Comparator: Placebo (Treatment Withdrawal Regimen) Period 1: participants are treated with OL GLM SC QM for up to 10 months; Period 2: participants are treated with double-blinded placebo for up to 12 months	Biological: Golimumab; Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.; Other Names: MK-8259 Simponi® ; Biological: Placebo; Injections of matching placebo for golimumab.
Experimental: OL GLM Retreatment Participants who experience a disease flare during double-blinded treatment in Period 2 will discontinue blinded treatment and receive OL GLM SC QM.	Biological: Golimumab; Injections of 50 mg golimumab. At the investigator's discretion, participants with a body weight of more than 100 kg could receive 100 mg injections with golimumab.; Other Names: MK-8259 Simponi®

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Without a Disease Activity Flare During Period 2 [Up to 12 months]

   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.

Secondary Outcome Measures

1. Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment [Up to 3 months following start of retreatment]

   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.

2. Time to First Disease Flare [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.

3. Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment) [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.

4. Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment) [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.

5. Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment) [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.

6. Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment) [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.

7. Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment) [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.

8. Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment) [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.

9. Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment) [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.

10. Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment) [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.

11. Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment) [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.

12. Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment) [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.

13. Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2 [Up to approximately 15 months]

    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.

14. Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2 [Up to approximately 12 months]

    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.

Other Outcome Measures

1. Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Withdrawal Regimens) [Up to 12 months]

   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.

2. Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Reduced Treatment Regimen) [Up to 12 months]

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Is not of reproductive potential, or is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner while receiving trial medication or within 6 months after the last dose of trial medication

• Has chronic back pain of ≥3 months duration by history

• Has physician-diagnosed active non-radiographic axial spondyloarthritis (nr-axSpA) with disease duration <= 5 years

• Meets one of the following criteria:

1. Has active inflammation on magnetic resonance imaging (MRI) highly suggestive of sacroiliitis associated with spondyloarthropathy and 1 or more of the following spondyloarthritis (SpA) characteristics:

• Inflammatory back pain

• Arthritis (physician-diagnosed)

• Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)

• Dactylitis (physician-diagnosed)

• Psoriasis (physician-diagnosed)

• History of physician-diagnosed inflammatory bowel disease (IBD)

• History of uveitis confirmed by an ophthalmologist

• Good response to nonsteroidal anti-inflammatory drugs (NSAID)

• Family history of SpA (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or IBD)

• Elevated C-reactive protein (CRP)

• Human leukocyte antigen B27 (HLA-B27)+ gene OR

1. Has a HLA-B27+ gene and 2 or more of the following SpA characteristics:

• Inflammatory back pain

• Arthritis (physician-diagnosed)

• Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)

• Dactylitis (physician-diagnosed)

• Psoriasis (physician-diagnosed)

• History of physician-diagnosed inflammatory bowel disease (IBD)

• History of uveitis confirmed by an ophthalmologist

• Good response to nonsteroidal anti-inflammatory drugs (NSAID)

• Family history of SpA (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or IBD)

• Elevated C-reactive protein (CRP)

• Has elevated CRP at Screening or evidence of active inflammation in the sacroiliac joints on MRI

• Has an Ankylosing Spondylitis Disease Activity Score (ASDAS) >= 2.1 at Screening

• Shows high disease activity at Screening and Baseline of both a Total Back Pain score of ≥4 and a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of >= 4

• Has an acceptable history of NSAID use

• Has no history of untreated latent or active tuberculosis (TB) prior to Screening

• Has had no recent close contact with a person with active TB or, if there has been such contact, will undergo additional evaluations and receive appropriate treatment for latent TB

• Agrees to undergo screening for hepatitis B virus (HBV) and demonstrates negative results for hepatitis B surface antigen (HBsAg) and HBV deoxyribonucleic acid (DNA)

Exclusion Criteria:

• Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional x-rays

• Is a nursing or pregnant female, or intends to become pregnant within 6 months after receiving trial medication

• Intends to donate eggs (female participants) or sperm (male participants) while receiving trial medication or within 6 months after trial medication

• Has any clinically significant condition or situation that would interfere with the trial evaluations or participation in the trial

• Has ever received any cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents

• Has received any treatment listed below more recently than the indicated off-drug period prior to Screening

• • Disease-modifying anti-rheumatic drugs (30 days off drug)

• • Live vaccinations (3 months off drug)

• • Investigational medications (30 days or 5 half-lives off drug, whichever is longer)

• • Bacille Calmette-Guerin (BCG) vaccination (12 months off drug)

• Has any systemic inflammatory condition, including psoriatic arthritis, active Lyme disease, systemic lupus erythematosus, infectious arthritis, vasculitis, parvovirus infection, rheumatoid arthritis, active uveitis, or active IBD

• Has a history of latent or active granulomatous infection prior to Screening

• Had a nontuberculous mycobacterial infection or opportunistic infection within 6 months prior to Screening

• Has a history of an infected joint prosthesis, or has received antibiotics for a suspected infection of a joint prosthesis, if that prosthesis has not been removed or replaced

• Had a serious infection, has been hospitalized for an infection, or has been treated with IV antibiotics for an infection within 2 months prior to Baseline

• Had a history of, or ongoing, chronic or recurrent infectious disease

• Is known to be infected with human immunodeficiency virus (HIV) or seropositive for hepatitis C virus (HCV)

• Has had a chest x-ray within 2 months prior to Screening that shows an abnormality suggestive of a current active infection or malignancy

• Has a history of lymphoproliferative disease

• Has had a malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of cervix that has been surgically cured)

• Has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis

• Has a history of or concurrent congestive heart failure of any grade

• Has a transplanted organ (with the exception of a corneal transplant performed >= 3 months prior to baseline)

• Has current signs or symptoms of significant medical illness which could interfere with the trial, or require treatment that might interfere with the trial

• Is a user of recreational or illicit drugs or has or had a substance abuse (drug or alcohol) problem within the previous 2 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	FN Brno ( Site 0005)	Brno		Czechia	625 00
2	Revmatologie s.r.o. ( Site 0009)	Brno		Czechia	638 00
3	Artroscan s.r.o. ( Site 0007)	Ostrava-Trebovice		Czechia	722 00
4	CCBR Ostrava s.r.o. ( Site 0001)	Ostrava		Czechia	702 00
5	CCR Czech a.s. ( Site 0003)	Pardubice		Czechia	530 02
6	CCR Prague s.r.o ( Site 0004)	Praha		Czechia	130 00
7	Fakultni nemocnice v Motole ( Site 0127)	Praha		Czechia	150 06
8	Medical Plus s.r.o ( Site 0010)	Uherske Hradiste		Czechia	686 01
9	PV - Medical s.r.o. ( Site 0006)	Zlin		Czechia	760 01
10	Universitaetsklinik der Charite Berlin ( Site 0023)	Berlin		Germany	12203
11	Rheumazentrum Ruhrgebiet ( Site 0021)	Herne		Germany	44649
12	U. klinikum Koeln AOER ( Site 0025)	Koeln		Germany	50937
13	Klinikum der Universitaet Muenchen - LMU ( Site 0026)	Muenchen		Germany	80336
14	Herbert Kellner Innere Medizin Rheumatologie und Gastroenterologie ( Site 0022)	Muenchen		Germany	80639
15	Antonius Ziekenhuis Sneek ( Site 0043)	Sneek	Friesland	Netherlands	8601 ZK
16	Vrij Universiteit Medisch Centrum ( Site 0044)	Amsterdam		Netherlands	1081 HV
17	Leids Universitair Medisch Centrum ( Site 0041)	Leiden		Netherlands	2333 ZA
18	Maasstad Ziekenhuis ( Site 0042)	Rotterdam		Netherlands	3079 DZ
19	Centrum Medyczne Pratia Katowice ( Site 0059)	Katowice	Slaskie	Poland	40-081
20	Prywatna Praktyka Lekarska, Dr. med. Pawel Hrycaj ( Site 0060)	Poznan	Wielkopolskie	Poland	61-397
21	NZOZ Osteo-Medic s.c. A. Racewicz, R. Supronik ( Site 0058)	Bialystok		Poland	15-351
22	Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 0153)	Bydgoszcz		Poland	85-168
23	Centrum Kliniczno-Badawcze ( Site 0152)	Elblag		Poland	82-300
24	Krakow Medical Centre ( Site 0052)	Krakow		Poland	31-501
25	NZOZ Reumed ( Site 0051)	Lublin		Poland	20-582
26	Pomorskie Cent. Reumatologiczne IM.Dr. Titz-Kosko W Sopocie Sp. Z.o.o. ( Site 0057)	Sopot		Poland	81-759
27	Lubelskie Centrum Diagnostyczne ( Site 0053)	Swidnik		Poland	21-040
28	NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych ( Site 0151)	Torun		Poland	87-100
29	Reumatika ( Site 0055)	Warszawa		Poland	02-691
30	Centrul Medical de Diagnostic si Tratament Ambulator Neomed ( Site 0177)	Brasov		Romania	500283
31	Clinical Hospital Ioan Cantacuzino ( Site 0184)	Bucaresti		Romania	020475
32	Colentina Clinical Hospital ( Site 0231)	Bucarest		Romania	020125
33	Spitalul Clinic Sfanta Maria ( Site 0182)	Bucharest		Romania	011172
34	SC Duo Medical SRL ( Site 0183)	Bucuresti		Romania	010584
35	Spitalul Clinic Judetean de Urgenta Cluj-Napoca ( Site 0176)	Cluj Napoca		Romania	400006
36	RKMed Center ( Site 0180)	Iasi		Romania	700127
37	S.C.Pelican Impex S.R.L ( Site 0232)	Oradea		Romania	410450
38	Covamed Serv SRL ( Site 0178)	Sfantu Gheorghe		Romania	520052
39	Cabinet Medical Medicina Interna Dr. Triff Carina ( Site 0179)	Timisoara		Romania	300766
40	GUZ Regional Clinical Hospital ( Site 0076)	Saratov	Oktyabrskiy Region	Russian Federation	410053
41	Rheumatology Research Institute n.a. V.A.Nasonova of RAMS ( Site 0061)	Moscow		Russian Federation	115522
42	SPb SBHI Clinical Rheumatological Hospital 25 ( Site 0077)	Saint Petersburg		Russian Federation	190068
43	SBHI Leningrad Regional Clinical Hospital ( Site 0065)	Saint Petersburg		Russian Federation	194291
44	LLC Sanavita ( Site 0074)	Saint-Petersburg		Russian Federation	195257
45	Tolyatti City Clinical Hospital 5 ( Site 0069)	Tolyatti		Russian Federation	445039
46	Yaroslavl Clinical Hospital for Emergency Care na. NV. Solovyev. ( Site 0075)	Yaroslavl		Russian Federation	150003
47	Hospital de Basurto ( Site 0082)	Bilbao		Spain	48013
48	Hospital Universitario Reina Sofia ( Site 0081)	Cordoba		Spain	14004
49	Hospital Universitario La Paz ( Site 0083)	Madrid		Spain	28046
50	Hospital Clinico Universitario Virgen de la Arrixaca ( Site 0085)	Murcia		Spain	30120
51	Akdeniz Universitesi Tip Fakultesi Romatoloji Departmani ( Site 0094)	Antalya	Ankara	Turkey	07070
52	Ankara Numune Egitim Arastirma Hastanesi ( Site 0092)	Ankara		Turkey	06100
53	Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0091)	Ankara		Turkey	06100
54	Ankara Universitesi Tıp Fakultesi ( Site 0093)	Ankara		Turkey	06230
55	Pamukkale Unv. Tip Fak. ( Site 0097)	Denizli		Turkey	20070
56	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0098)	Istanbul		Turkey	34899
57	Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari ( Site 0096)	Kocaeli		Turkey	41380
58	Cherkassy Regional hospital of Cherkassy Regional council ( Site 0221)	Cherkassy		Ukraine	18009
59	MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222)	Dnipropetrovsk		Ukraine	49005
60	SI National Institute of therapy n.a L.T. Maloi NAMS of Ukraine ( Site 0261)	Kharkiv		Ukraine	61039
61	ME of Health Care Kharkiv City Clinical Hospital #8 ( Site 0262)	Kharkiv		Ukraine	61176
62	Kyivska miska klinichna likarnia N3 ( Site 0266)	Kyiv		Ukraine	02125
63	M. D. Strazhesko Institute of Cardiology. ( Site 0264)	Kyiv		Ukraine	03680
64	Medical Center Ibn Sina ( Site 0268)	Kyiv		Ukraine	04050
65	Clinic of Modern Rheumatology ( Site 0265)	Kyiv		Ukraine	04070
66	Communal City Clinical Hospital #4 ( Site 0230)	Lviv		Ukraine	79011
67	MI Odesa Regional Clinical Hospital ( Site 0226)	Odesa		Ukraine	65117
68	M.V.Sklifosovskyi Poltava Regional Clinical Hospital ( Site 0224)	Poltava		Ukraine	36011
69	Vinnitsa Regional Clinical Hospital n.a. Pirogov ( Site 0225)	Vinnutsya		Ukraine	21018
70	SRI of Invalid Rehabilitation of Vinnytsia M.I.Pyrogov ( Site 0263)	Vinnytsia		Ukraine	21000
71	Zaporizhzha Regional Clinical Hospital ( Site 0223)	Zaporizhzhya		Ukraine	69600

Sponsors and Collaborators

• Merck Sharp & Dohme LLC

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 21, 2017

More Information

Publications

None provided.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT03253796
• Other Study ID Numbers: 8259-038; MK-8259-038; 2015-004020-65
• First Posted: Aug 18, 2017
• Last Update Posted: May 4, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spondylitis; Spondylarthritis; Golimumab

Study Results

Participant Flow

Arm/Group Title	Open-Label Run-In Golimumab QM	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)	Open-Label Retreatment
Arm/Group Description	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.	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.	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.	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.	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 Title: Period 1: Run-In
STARTED	323	0	0	0	0
COMPLETED	207	0	0	0	0
NOT COMPLETED	116	0	0	0	0
Period Title: Period 1: Run-In
STARTED	0	63	64	62	0
COMPLETED	0	53	43	21	0
NOT COMPLETED	0	10	21	41	0
Period Title: Period 1: Run-In
STARTED	0	0	0	0	63
COMPLETED	0	0	0	0	58
NOT COMPLETED	0	0	0	0	5

Baseline Characteristics

Arm/Group Title	Open-Label Run-In Golimumab QM	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)	Open-Label Retreatment	Total
Arm/Group Description	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.	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.	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.	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.	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 of all reporting groups
Overall Participants	323	63	64	62	63	575
Age (Years) [Mean (Standard Deviation) ]
Period 1: Open-Label Run-In	32.5 (7.2)	32.5 (7.2)
Period 2: Withdrawal vs Continued Tx	31.4 (8.0)	30.8 (6.7)	32.9 (6.8)	31.7 (7.2)
Period 2: Open-Label Retreatment	33.4 (6.7)	33.4 (6.7)
Sex: Female, Male (Count of Participants)
Female	109 33.7%	109 173%
Male	214 66.3%	214 339.7%
Female	19 5.9%	21 33.3%	16 25%	56 90.3%
Male	44 13.6%	43 68.3%	46 71.9%	133 214.5%
Female	20 6.2%	20 31.7%
Male	43 13.3%	43 68.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 0.6%	2 3.2%
Not Hispanic or Latino	321 99.4%	321 509.5%
Unknown or Not Reported	0 0%	0 0%
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	63 19.5%	64 101.6%	62 96.9%	189 304.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Hispanic or Latino	0 0%	0 0%
Not Hispanic or Latino	63 19.5%	63 100%
Unknown or Not Reported	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%
Black or African American	0 0%	0 0%
White	323 100%	323 512.7%
More than one race	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	63 19.5%	64 101.6%	62 96.9%	189 304.8%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
American Indian or Alaska Native	0 0%	0 0%
Asian	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%
Black or African American	0 0%	0 0%
White	63 19.5%	63 100%
More than one race	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%
C-Reactive Protein (CRP) Category at Enrollment (Count of Participants)
> 6 mg/L	196 60.7%	196 311.1%
≤ 6 mg/L	127 39.3%	127 201.6%
> 6 mg/L	40 12.4%	40 63.5%	39 60.9%	119 191.9%
≤ 6 mg/L	23 7.1%	24 38.1%	23 35.9%	70 112.9%
> 6 mg/L	38 11.8%	38 60.3%
≤ 6 mg/L	25 7.7%	25 39.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Without a Disease Activity Flare During Period 2
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)
Arm/Group Description	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.	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.	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.
Measure Participants	63	63	62
Number [Percentage of participants]	84.1 26%	68.3 108.4%	33.9 53%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab QM (Full Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Miettinen and Nurminen
	Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	50.2
	Confidence Interval	(2-Sided) 95%; 34.1 to 63.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Golimumab Q2M (Reduced Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Meittinen and Nurminen
	Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	34.4
	Confidence Interval	(2-Sided) 95%; 17.0 to 49.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment
Description	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.
Time Frame	Up to 3 months following start of retreatment

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Open-Label Retreatment
Arm/Group Description	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.
Measure Participants	53
Within 1 month of retreatment	90.6 28%
Within 2 months of retreatment	96.2 29.8%
Within 3 months of retreatment	96.2 29.8%
Sustained clinical response	71.7 22.2%

3. Secondary Outcome

Title	Time to First Disease Flare
Description	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.
Time Frame	Month 3, Month 6, Month 9, and Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)
Arm/Group Description	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.	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.	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.
Measure Participants	63	63	62
Month 3	14.3 4.4%	7.9 12.5%	41.9 65.5%
Month 6	14.3 4.4%	17.5 27.8%	58.1 90.8%
Month 9	14.3 4.4%	20.6 32.7%	61.3 95.8%
Month 12	15.9 4.9%	23.8 37.8%	61.3 95.8%

4. Secondary Outcome

Title	Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)
Arm/Group Description	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.	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.	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.
Measure Participants	63	63	62
Number [Percentage of participants]	9.5 2.9%	3.2 5.1%	0.0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab QM (Full Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	9.5
	Confidence Interval	(2-Sided) 95%; 3.3 to 19.4
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Golimumab Q2M (Reduced Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	3.2
	Confidence Interval	(2-Sided) 95%; -2.8 to 10.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

5. Secondary Outcome

Title	Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Open-Label Retreatment
Arm/Group Description	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.
Measure Participants	53
Number (95% Confidence Interval) [Percentage of participants]	94.3 29.2%

6. Secondary Outcome

Title	Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)
Arm/Group Description	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.	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.	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.
Measure Participants	63	63	62
Number [Percentage of participants]	0 0%	0 0%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab QM (Full Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -5.9 to 5.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Golimumab Q2M (Reduced Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0.0
	Confidence Interval	(2-Sided) 95%; -5.9 to 5.8
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

7. Secondary Outcome

Title	Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Open-Label Retreatment
Arm/Group Description	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.
Measure Participants	53
Number (95% Confidence Interval) [Percentage of participants]	90.6 28%

8. Secondary Outcome

Title	Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)
Arm/Group Description	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.	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.	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.
Measure Participants	63	63	62
Number [Percentage of participants]	85.7 26.5%	85.7 136%	71.0 110.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab QM (Full Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95%; 0.2 to 29.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Golimumab Q2M (Reduced Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95%; 0.2 to 29.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

9. Secondary Outcome

Title	Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Open-Label Retreatment
Arm/Group Description	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.
Measure Participants	53
Number (95% Confidence Interval) [Percentage of participants]	92.5 28.6%

10. Secondary Outcome

Title	Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)
Arm/Group Description	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.	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.	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.
Measure Participants	63	63	62
Number [Percentage of participants]	49.2 15.2%	30.2 47.9%	24.2 37.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab QM (Full Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	24.9
	Confidence Interval	(2-Sided) 95%; 8.5 to 40.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Golimumab Q2M (Reduced Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	5.9
	Confidence Interval	(2-Sided) 95%; -9.9 to 21.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

11. Secondary Outcome

Title	Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Open-Label Retreatment
Arm/Group Description	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.
Measure Participants	53
Number (95% Confidence Interval) [Percentage of participants]	98.1 30.4%

12. Secondary Outcome

Title	Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)
Arm/Group Description	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.	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.	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.
Measure Participants	63	63	62
Number [Percentage of participants]	85.7 26.5%	84.1 133.5%	61.3 95.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab QM (Full Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	24.4
	Confidence Interval	(2-Sided) 95%; 9.1 to 39.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Golimumab Q2M (Reduced Treatment Regimen), Placebo (Treatment Withdrawal Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	22.8
	Confidence Interval	(2-Sided) 95%; 7.3 to 37.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor

13. Secondary Outcome

Title	Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Open-Label Retreatment
Arm/Group Description	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.
Measure Participants	53
Number (95% Confidence Interval) [Percentage of participants]	90.6 28%

14. Secondary Outcome

Title	Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2
Description	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.
Time Frame	Up to approximately 15 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)	Open-Label Retreatment
Arm/Group Description	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.	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.	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.	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.
Measure Participants	63	64	62	63
Number [Percentage of participants]	46.0 14.2%	46.9 74.4%	32.3 50.5%	41.3 66.6%

15. Secondary Outcome

Title	Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2
Description	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.
Time Frame	Up to approximately 12 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)	Placebo (Treatment Withdrawal Regimen)	Open-Label Retreatment
Arm/Group Description	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.	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.	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.	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.
Measure Participants	63	64	62	63
Number [Percentage of participants]	0.0 0%	4.7 7.5%	1.6 2.5%	0.0 0%

16. Other Pre-specified Outcome

Title	Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Withdrawal Regimens)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M and Placebo (Withdrawal Regimens)
Arm/Group Description	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 were treated with double-blinded SC injections of 50 mg golimumab Q2M alternating with matching placebo to golimumab every other month or with placebo 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.
Measure Participants	63	125
Number [Percentage of participants]	84.1 26%	51.2 81.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab QM (Full Treatment Regimen), Golimumab Q2M (Reduced Treatment Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Miettinen and Nurminen
	Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	32.9
	Confidence Interval	(2-Sided) 95%; 19.2 to 44.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Other Pre-specified Outcome

Title	Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Reduced Treatment Regimen)
Description	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.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Golimumab QM (Full Treatment Regimen)	Golimumab Q2M (Reduced Treatment Regimen)
Arm/Group Description	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 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.
Measure Participants	63	63
Number [Percentage of participants]	84.1 26%	68.3 108.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Golimumab QM (Full Treatment Regimen), Golimumab Q2M (Reduced Treatment Regimen)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.037
	Comments
	Method	Miettinen and Nurminen
	Comments	Derived based on the stratified Miettinen and Nurminen method with CRP level (>6 mg/L or ≤ 6 mg/L) as a stratification factor
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	15.9
	Confidence Interval	(2-Sided) 95%; 0.9 to 30.5
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	The safety analysis population includes all participants who received at least one dose of study intervention.
Arm/Group Title	Open-Label Run-In Golimumab QM		Golimumab QM (Full Treatment Regimen)		Golimumab Q2M (Reduced Treatment Regimen)		Placebo (Treatment Withdrawal Regimen)		Open-Label Retreatment
Arm/Group Description	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.		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.		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.		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.		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.
All Cause Mortality
	Open-Label Run-In Golimumab QM		Golimumab QM (Full Treatment Regimen)		Golimumab Q2M (Reduced Treatment Regimen)		Placebo (Treatment Withdrawal Regimen)		Open-Label Retreatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/323 (0%)		0/63 (0%)		0/64 (0%)		0/62 (0%)		0/63 (0%)
Serious Adverse Events
	Open-Label Run-In Golimumab QM		Golimumab QM (Full Treatment Regimen)		Golimumab Q2M (Reduced Treatment Regimen)		Placebo (Treatment Withdrawal Regimen)		Open-Label Retreatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/323 (2.2%)		1/63 (1.6%)		1/64 (1.6%)		1/62 (1.6%)		0/63 (0%)
Hepatobiliary disorders
Cholecystitis chronic	1/323 (0.3%)	1	0/63 (0%)	0	0/64 (0%)	0	0/62 (0%)	0	0/63 (0%)	0
Infections and infestations
Pilonidal cyst	1/323 (0.3%)	1	0/63 (0%)	0	0/64 (0%)	0	0/62 (0%)	0	0/63 (0%)	0
Pyelonephritis acute	0/323 (0%)	0	0/63 (0%)	0	1/64 (1.6%)	1	0/62 (0%)	0	0/63 (0%)	0
Sinusitis bacterial	1/323 (0.3%)	1	0/63 (0%)	0	0/64 (0%)	0	0/62 (0%)	0	0/63 (0%)	0
Injury, poisoning and procedural complications
Joint injury	0/323 (0%)	0	1/63 (1.6%)	1	0/64 (0%)	0	0/62 (0%)	0	0/63 (0%)	0
Meniscus injury	0/323 (0%)	0	0/63 (0%)	0	0/64 (0%)	0	1/62 (1.6%)	1	0/63 (0%)	0
Musculoskeletal and connective tissue disorders
Arthritis	1/323 (0.3%)	1	0/63 (0%)	0	0/64 (0%)	0	0/62 (0%)	0	0/63 (0%)	0
Exostosis	1/323 (0.3%)	1	0/63 (0%)	0	0/64 (0%)	0	0/62 (0%)	0	0/63 (0%)	0
Joint instability	1/323 (0.3%)	1	0/63 (0%)	0	0/64 (0%)	0	0/62 (0%)	0	0/63 (0%)	0
Renal and urinary disorders
Renal colic	1/323 (0.3%)	1	0/63 (0%)	0	1/64 (1.6%)	1	0/62 (0%)	0	0/63 (0%)	0
Other (Not Including Serious) Adverse Events
	Open-Label Run-In Golimumab QM		Golimumab QM (Full Treatment Regimen)		Golimumab Q2M (Reduced Treatment Regimen)		Placebo (Treatment Withdrawal Regimen)		Open-Label Retreatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/323 (24.5%)		13/63 (20.6%)		17/64 (26.6%)		11/62 (17.7%)		11/63 (17.5%)
Infections and infestations
Nasopharyngitis	36/323 (11.1%)	39	6/63 (9.5%)	7	6/64 (9.4%)	6	3/62 (4.8%)	4	4/63 (6.3%)	4
Pharyngitis	12/323 (3.7%)	14	2/63 (3.2%)	2	6/64 (9.4%)	9	3/62 (4.8%)	4	1/63 (1.6%)	1
Upper respiratory tract infection	16/323 (5%)	24	2/63 (3.2%)	5	3/64 (4.7%)	3	2/62 (3.2%)	3	5/63 (7.9%)	5
Nervous system disorders
Headache	24/323 (7.4%)	39	4/63 (6.3%)	8	2/64 (3.1%)	3	4/62 (6.5%)	5	1/63 (1.6%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.