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

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

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.

Study Overview

• Status: Completed
• Conditions: Spondyloarthritis
• Intervention / Treatment: Biological: Golimumab; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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: Simponi®; MK-8259
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: Simponi®; MK-8259; 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: Simponi®; MK-8259; 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: Simponi®; MK-8259

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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). Rheumatology (Oxford). 2023 Mar 15:kead112. doi: 10.1093/rheumatology/kead112. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2017
• Primary Completion (Actual): March 17, 2021
• Study Completion (Actual): March 17, 2021

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tumor Necrosis Factor Inhibitors; Golimumab
• Other Study ID Numbers: 8259-038; MK-8259-038 (Other Identifier: Merck); 2015-004020-65 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No