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

Primary Purpose

Spondyloarthritis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Golimumab

Placebo

About this trial

This is an interventional treatment trial for Spondyloarthritis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

GLM SC QM (Full Treatment Regimen)

GLM SC Q2M (Reduced Treatment Regimen)

Placebo (Treatment Withdrawal Regimen)

OL GLM Retreatment

Arm Description

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

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

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

Participants who experience a disease flare during double-blinded treatment in Period 2 will discontinue blinded treatment and receive OL GLM SC QM.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2

Full Information

NCT ID

NCT03253796

First Posted

August 16, 2017

Last Updated

July 25, 2023

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT03253796

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

November 7, 2017 (Actual)

Primary Completion Date

March 17, 2021 (Actual)

Study Completion Date

March 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondyloarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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).

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

323 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GLM SC QM (Full Treatment Regimen)

Arm Type

Experimental

Arm Description

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

Arm Title

GLM SC Q2M (Reduced Treatment Regimen)

Arm Type

Experimental

Arm Description

Arm Title

Placebo (Treatment Withdrawal Regimen)

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

OL GLM Retreatment

Arm Type

Experimental

Arm Description

Participants who experience a disease flare during double-blinded treatment in Period 2 will discontinue blinded treatment and receive OL GLM SC QM.

Intervention Type

Biological

Intervention Name(s)

Golimumab

Other Intervention Name(s)

MK-8259, Simponi®

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

Injections of matching placebo for golimumab.

Primary Outcome Measure Information:

Title

Percentage of Participants Without a Disease Activity Flare During Period 2

Description

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment

Description

Time Frame

Up to 3 months following start of retreatment

Title

Time to First Disease Flare

Description

Time Frame

Month 3, Month 6, Month 9, and Month 12

Title

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

Description

Time Frame

Up to 12 months

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

Title

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

Description

Time Frame

Up to 12 months

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

Title

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

Description

Time Frame

Up to 12 months

Title

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

Description

Time Frame

Up to 12 months

Title

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

Description

Time Frame

Up to 12 months

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

Title

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

Description

Time Frame

Up to 12 months

Title

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

Description

Time Frame

Up to 12 months

Title

Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2

Description

Time Frame

Up to approximately 15 months

Title

Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2

Description

Time Frame

Up to approximately 12 months

Other Pre-specified Outcome Measures:

Title

Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Withdrawal Regimens)

Description

Time Frame

Up to 12 months

Title

Percentage of Participants Without a Disease Activity Flare During Period 2 (Full Treatment Regimen Versus Reduced Treatment Regimen)

Description

Time Frame

Up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

Facility Information:

Facility Name

FN Brno ( Site 0005)

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Revmatologie s.r.o. ( Site 0009)

City

Brno

ZIP/Postal Code

638 00

Country

Czechia

Facility Name

Artroscan s.r.o. ( Site 0007)

City

Ostrava-Trebovice

ZIP/Postal Code

722 00

Country

Czechia

Facility Name

CCBR Ostrava s.r.o. ( Site 0001)

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

CCR Czech a.s. ( Site 0003)

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

CCR Prague s.r.o ( Site 0004)

City

Praha

ZIP/Postal Code

130 00

Country

Czechia

Facility Name

Fakultni nemocnice v Motole ( Site 0127)

City

Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Medical Plus s.r.o ( Site 0010)

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

PV - Medical s.r.o. ( Site 0006)

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Universitaetsklinik der Charite Berlin ( Site 0023)

City

Berlin

ZIP/Postal Code

12203

Country

Germany

Facility Name

Rheumazentrum Ruhrgebiet ( Site 0021)

City

Herne

ZIP/Postal Code

44649

Country

Germany

Facility Name

U. klinikum Koeln AOER ( Site 0025)

City

Koeln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Klinikum der Universitaet Muenchen - LMU ( Site 0026)

City

Muenchen

ZIP/Postal Code

80336

Country

Germany

Facility Name

Herbert Kellner Innere Medizin Rheumatologie und Gastroenterologie ( Site 0022)

City

Muenchen

ZIP/Postal Code

80639

Country

Germany

Facility Name

Antonius Ziekenhuis Sneek ( Site 0043)

City

Sneek

State/Province

Friesland

ZIP/Postal Code

8601 ZK

Country

Netherlands

Facility Name

Vrij Universiteit Medisch Centrum ( Site 0044)

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Leids Universitair Medisch Centrum ( Site 0041)

City

Leiden

ZIP/Postal Code

2333 ZA

Country

Netherlands

Facility Name

Maasstad Ziekenhuis ( Site 0042)

City

Rotterdam

ZIP/Postal Code

3079 DZ

Country

Netherlands

Facility Name

Centrum Medyczne Pratia Katowice ( Site 0059)

City

Katowice

State/Province

Slaskie

ZIP/Postal Code

40-081

Country

Poland

Facility Name

Prywatna Praktyka Lekarska, Dr. med. Pawel Hrycaj ( Site 0060)

City

Poznan

State/Province

Wielkopolskie

ZIP/Postal Code

61-397

Country

Poland

Facility Name

NZOZ Osteo-Medic s.c. A. Racewicz, R. Supronik ( Site 0058)

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 0153)

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

Centrum Kliniczno-Badawcze ( Site 0152)

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Krakow Medical Centre ( Site 0052)

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

NZOZ Reumed ( Site 0051)

City

Lublin

ZIP/Postal Code

20-582

Country

Poland

Facility Name

Pomorskie Cent. Reumatologiczne IM.Dr. Titz-Kosko W Sopocie Sp. Z.o.o. ( Site 0057)

City

Sopot

ZIP/Postal Code

81-759

Country

Poland

Facility Name

Lubelskie Centrum Diagnostyczne ( Site 0053)

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych ( Site 0151)

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Reumatika ( Site 0055)

City

Warszawa

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Centrul Medical de Diagnostic si Tratament Ambulator Neomed ( Site 0177)

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

Clinical Hospital Ioan Cantacuzino ( Site 0184)

City

Bucaresti

ZIP/Postal Code

020475

Country

Romania

Facility Name

Colentina Clinical Hospital ( Site 0231)

City

Bucarest

ZIP/Postal Code

020125

Country

Romania

Facility Name

Spitalul Clinic Sfanta Maria ( Site 0182)

City

Bucharest

ZIP/Postal Code

011172

Country

Romania

Facility Name

SC Duo Medical SRL ( Site 0183)

City

Bucuresti

ZIP/Postal Code

010584

Country

Romania

Facility Name

Spitalul Clinic Judetean de Urgenta Cluj-Napoca ( Site 0176)

City

Cluj Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

RKMed Center ( Site 0180)

City

Iasi

ZIP/Postal Code

700127

Country

Romania

Facility Name

S.C.Pelican Impex S.R.L ( Site 0232)

City

Oradea

ZIP/Postal Code

410450

Country

Romania

Facility Name

Covamed Serv SRL ( Site 0178)

City

Sfantu Gheorghe

ZIP/Postal Code

520052

Country

Romania

Facility Name

Cabinet Medical Medicina Interna Dr. Triff Carina ( Site 0179)

City

Timisoara

ZIP/Postal Code

300766

Country

Romania

Facility Name

GUZ Regional Clinical Hospital ( Site 0076)

City

Saratov

State/Province

Oktyabrskiy Region

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Rheumatology Research Institute n.a. V.A.Nasonova of RAMS ( Site 0061)

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

SPb SBHI Clinical Rheumatological Hospital 25 ( Site 0077)

City

Saint Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

SBHI Leningrad Regional Clinical Hospital ( Site 0065)

City

Saint Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

LLC Sanavita ( Site 0074)

City

Saint-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Tolyatti City Clinical Hospital 5 ( Site 0069)

City

Tolyatti

ZIP/Postal Code

445039

Country

Russian Federation

Facility Name

Yaroslavl Clinical Hospital for Emergency Care na. NV. Solovyev. ( Site 0075)

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Hospital de Basurto ( Site 0082)

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Hospital Universitario Reina Sofia ( Site 0081)

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hospital Universitario La Paz ( Site 0083)

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Clinico Universitario Virgen de la Arrixaca ( Site 0085)

City

Murcia

ZIP/Postal Code

30120

Country

Spain

Facility Name

Akdeniz Universitesi Tip Fakultesi Romatoloji Departmani ( Site 0094)

City

Antalya

State/Province

Ankara

ZIP/Postal Code

07070

Country

Turkey

Facility Name

Ankara Numune Egitim Arastirma Hastanesi ( Site 0092)

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 0091)

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Ankara Universitesi Tıp Fakultesi ( Site 0093)

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Pamukkale Unv. Tip Fak. ( Site 0097)

City

Denizli

ZIP/Postal Code

20070

Country

Turkey

Facility Name

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 0098)

City

Istanbul

ZIP/Postal Code

34899

Country

Turkey

Facility Name

Kocaeli Universitesi Tip Fakultesi Ic Hastaliklari ( Site 0096)

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Cherkassy Regional hospital of Cherkassy Regional council ( Site 0221)

City

Cherkassy

ZIP/Postal Code

18009

Country

Ukraine

Facility Name

MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 0222)

City

Dnipropetrovsk

ZIP/Postal Code

49005

Country

Ukraine

Facility Name

SI National Institute of therapy n.a L.T. Maloi NAMS of Ukraine ( Site 0261)

City

Kharkiv

ZIP/Postal Code

61039

Country

Ukraine

Facility Name

ME of Health Care Kharkiv City Clinical Hospital #8 ( Site 0262)

City

Kharkiv

ZIP/Postal Code

61176

Country

Ukraine

Facility Name

Kyivska miska klinichna likarnia N3 ( Site 0266)

City

Kyiv

ZIP/Postal Code

02125

Country

Ukraine

Facility Name

M. D. Strazhesko Institute of Cardiology. ( Site 0264)

City

Kyiv

ZIP/Postal Code

03680

Country

Ukraine

Facility Name

Medical Center Ibn Sina ( Site 0268)

City

Kyiv

ZIP/Postal Code

04050

Country

Ukraine

Facility Name

Clinic of Modern Rheumatology ( Site 0265)

City

Kyiv

ZIP/Postal Code

04070

Country

Ukraine

Facility Name

Communal City Clinical Hospital #4 ( Site 0230)

City

Lviv

ZIP/Postal Code

79011

Country

Ukraine

Facility Name

MI Odesa Regional Clinical Hospital ( Site 0226)

City

Odesa

ZIP/Postal Code

65117

Country

Ukraine

Facility Name

M.V.Sklifosovskyi Poltava Regional Clinical Hospital ( Site 0224)

City

Poltava

ZIP/Postal Code

36011

Country

Ukraine

Facility Name

Vinnitsa Regional Clinical Hospital n.a. Pirogov ( Site 0225)

City

Vinnutsya

ZIP/Postal Code

21018

Country

Ukraine

Facility Name

SRI of Invalid Rehabilitation of Vinnytsia M.I.Pyrogov ( Site 0263)

City

Vinnytsia

ZIP/Postal Code

21000

Country

Ukraine

Facility Name

Zaporizhzha Regional Clinical Hospital ( Site 0223)

City

Zaporizhzhya

ZIP/Postal Code

69600

Country

Ukraine

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

IPD Sharing URL

http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

36919768

Citation

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.

Results Reference

result

Learn more about this trial

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

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