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

Spondyloarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03253796
• Other study ID #: 8259-038
• Secondary ID: MK-8259-0382015-
• Status: Completed
• Phase: Phase 4
• Start date: November 7, 2017
• Est. completion date: March 17, 2021

Study information

• Verified date: July 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: March 17, 2021
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

2. 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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Non-Radiographic Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis

Intervention

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.
• Placebo
Injections of matching placebo for golimumab.

Locations

Country	Name	City	State
Czechia	FN Brno ( Site 0005)	Brno
Czechia	Revmatologie s.r.o. ( Site 0009)	Brno
Czechia	CCBR Ostrava s.r.o. ( Site 0001)	Ostrava
Czechia	Artroscan s.r.o. ( Site 0007)	Ostrava-Trebovice
Czechia	CCR Czech a.s. ( Site 0003)	Pardubice
Czechia	CCR Prague s.r.o ( Site 0004)	Praha
Czechia	Fakultni nemocnice v Motole ( Site 0127)	Praha
Czechia	Medical Plus s.r.o ( Site 0010)	Uherske Hradiste
Czechia	PV - Medical s.r.o. ( Site 0006)	Zlin
Germany	Universitaetsklinik der Charite Berlin ( Site 0023)	Berlin
Germany	Rheumazentrum Ruhrgebiet ( Site 0021)	Herne
Germany	U. klinikum Koeln AOER ( Site 0025)	Koeln
Germany	Herbert Kellner Innere Medizin Rheumatologie und Gastroenterologie ( Site 0022)	Muenchen
Germany	Klinikum der Universitaet Muenchen - LMU ( Site 0026)	Muenchen
Netherlands	Vrij Universiteit Medisch Centrum ( Site 0044)	Amsterdam
Netherlands	Leids Universitair Medisch Centrum ( Site 0041)	Leiden
Netherlands	Maasstad Ziekenhuis ( Site 0042)	Rotterdam
Netherlands	Antonius Ziekenhuis Sneek ( Site 0043)	Sneek	Friesland
Poland	NZOZ Osteo-Medic s.c. A. Racewicz, R. Supronik ( Site 0058)	Bialystok
Poland	Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 0153)	Bydgoszcz
Poland	Centrum Kliniczno-Badawcze ( Site 0152)	Elblag
Poland	Centrum Medyczne Pratia Katowice ( Site 0059)	Katowice	Slaskie
Poland	Krakow Medical Centre ( Site 0052)	Krakow
Poland	NZOZ Reumed ( Site 0051)	Lublin
Poland	Prywatna Praktyka Lekarska, Dr. med. Pawel Hrycaj ( Site 0060)	Poznan	Wielkopolskie
Poland	Pomorskie Cent. Reumatologiczne IM.Dr. Titz-Kosko W Sopocie Sp. Z.o.o. ( Site 0057)	Sopot
Poland	Lubelskie Centrum Diagnostyczne ( Site 0053)	Swidnik
Poland	NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych ( Site 0151)	Torun
Poland	Reumatika ( Site 0055)	Warszawa
Romania	Centrul Medical de Diagnostic si Tratament Ambulator Neomed ( Site 0177)	Brasov
Romania	Colentina Clinical Hospital ( Site 0231)	Bucarest
Romania	Clinical Hospital Ioan Cantacuzino ( Site 0184)	Bucaresti
Romania	Spitalul Clinic Sfanta Maria ( Site 0182)	Bucharest
Romania	SC Duo Medical SRL ( Site 0183)	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Cluj-Napoca ( Site 0176)	Cluj Napoca
Romania	RKMed Center ( Site 0180)	Iasi
Romania	S.C.Pelican Impex S.R.L ( Site 0232)	Oradea
Romania	Covamed Serv SRL ( Site 0178)	Sfantu Gheorghe
Romania	Cabinet Medical Medicina Interna Dr. Triff Carina ( Site 0179)	Timisoara
Russian Federation	Rheumatology Research Institute n.a. V.A.Nasonova of RAMS ( Site 0061)	Moscow
Russian Federation	SBHI Leningrad Regional Clinical Hospital ( Site 0065)	Saint Petersburg
Russian Federation	SPb SBHI Clinical Rheumatological Hospital 25 ( Site 0077)	Saint Petersburg
Russian Federation	LLC Sanavita ( Site 0074)	Saint-Petersburg
Russian Federation	GUZ Regional Clinical Hospital ( Site 0076)	Saratov	Oktyabrskiy Region
Russian Federation	Tolyatti City Clinical Hospital 5 ( Site 0069)	Tolyatti
Russian Federation	Yaroslavl Clinical Hospital for Emergency Care na. NV. Solovyev. ( Site 0075)	Yaroslavl
Spain	Hospital de Basurto ( Site 0082)	Bilbao
Spain	Hospital Universitario Reina Sofia ( Site 0081)	Cordoba
Spain	Hospital Universitario La Paz ( Site 0083)	Madrid
Spain	Hospital Clinico Universitario Virgen de la Arrixaca ( Site 0085)	Murcia
Turkey	Ankara Numune Egitim Arastirma Hastanesi ( Site 0092)	Ankara
Turkey	Ankara Universitesi Tip Fakultesi ( Site 0093)	Ankara
Turkey	Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0091)	Ankara
Turkey	Akdeniz Universitesi Tip Fakultesi Romatoloji Departmani ( Site 0094)	Antalya	Ankara
Turkey	Pamukkale Unv. Tip Fak. ( Site 0097)	Denizli
Turkey	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0098)	Istanbul
Turkey	Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari ( Site 0096)	Kocaeli
Ukraine	Cherkassy Regional hospital of Cherkassy Regional council ( Site 0221)	Cherkassy
Ukraine	MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222)	Dnipropetrovsk
Ukraine	ME of Health Care Kharkiv City Clinical Hospital #8 ( Site 0262)	Kharkiv
Ukraine	SI National Institute of therapy n.a L.T. Maloi NAMS of Ukraine ( Site 0261)	Kharkiv
Ukraine	Clinic of Modern Rheumatology ( Site 0265)	Kyiv
Ukraine	Kyivska miska klinichna likarnia N3 ( Site 0266)	Kyiv
Ukraine	M. D. Strazhesko Institute of Cardiology. ( Site 0264)	Kyiv
Ukraine	Medical Center Ibn Sina ( Site 0268)	Kyiv
Ukraine	Communal City Clinical Hospital #4 ( Site 0230)	Lviv
Ukraine	MI Odesa Regional Clinical Hospital ( Site 0226)	Odesa
Ukraine	M.V.Sklifosovskyi Poltava Regional Clinical Hospital ( Site 0224)	Poltava
Ukraine	Vinnitsa Regional Clinical Hospital n.a. Pirogov ( Site 0225)	Vinnutsya
Ukraine	SRI of Invalid Rehabilitation of Vinnytsia M.I.Pyrogov ( Site 0263)	Vinnytsia
Ukraine	Zaporizhzha Regional Clinical Hospital ( Site 0223)	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

Czechia,  Germany,  Netherlands,  Poland,  Romania,  Russian Federation,  Spain,  Turkey,  Ukraine, 

References & Publications (1)

Weinstein CLJ, Sliwinska-Stanczyk P, Hala T, Stanislav M, Tzontcheva A, Yao R, Berd Y, Curtis SP, Phillip G. Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK). Rheumato — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Withdrawal Regimens)	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.	Up to 12 months
Other	Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Reduced Treatment Regimen)	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.	Up to 12 months
Primary	Percentage of Participants Without a Disease Activity Flare During Period 2	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.	Up to 12 months
Secondary	Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab 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.	Up to 3 months following start of retreatment
Secondary	Time to First Disease Flare	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.	Month 3, Month 6, Month 9, and Month 12
Secondary	Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)	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.	Up to 12 months
Secondary	Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment)	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.	Up to 12 months
Secondary	Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2	This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE. The analysis includes AEs that occurred through 90 days after the last dose of study treatment.	Up to approximately 15 months
Secondary	Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2	This endpoint evaluated the safety and tolerability of withdrawing from or continuing treatment with golimumab in Period 2. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE could be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of study treatment, is also an AE.	Up to approximately 12 months