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Phase 4 Completed N=323 Randomized Double-blind Treatment

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

Spondyloarthritis
Source: ClinicalTrials.gov NCT03253796 ↗
Enrolled (actual)
323
Serious AEs
1.7%
Results posted
May 2022
Primary outcomePrimary: Percentage of Participants Without a Disease Activity Flare During Period 2 — 84.1; 68.3; 33.9 Percentage of participants — p=<0.001
◆ Published Evidence
Emerging
10citations · ~3 / year
Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK).
Rheumatology (Oxford, England) · 2023 · Open access · High-confidence link

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.

Linked Publications

  • Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK).
    Rheumatology (Oxford, England) · 2023 · 10 citations · Open access · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Without a Disease Activity Flare During Period 2
84.1; 68.3; 33.9 <0.001 sig
SECONDARY
Percentage of Participants With a Flare Who Show a Clinical Response Within 3 Months of Open-Label Golimumab Retreatment
90.6; 96.2; 96.2; 71.7
SECONDARY
Time to First Disease Flare
14.3; 7.9; 41.9; 14.3; 17.5; 58.1
SECONDARY
Percentage of Participants Achieving ASAS20 (Assessment in SpondyloArthritis International Society) Response (Double-blind Treatment)
9.5; 3.2; 0.0
SECONDARY
Percentage of Participants Achieving ASAS20 Response (Open-label Retreatment)
94.3
SECONDARY
Percentage of Participants Achieving ASAS40 Response (Double-blind Treatment)
0; 0; 0
SECONDARY
Percentage of Participants Achieving ASAS40 Response (Open-label Retreatment)
90.6
SECONDARY
Percentage of Participants Achieving ASAS Partial Remission (Double-blind Treatment)
85.7; 85.7; 71.0
SECONDARY
Percentage of Participants Achieving ASAS Partial Remission (Open-label Retreatment)
92.5
SECONDARY
Percentage of Participants Achieving BASDAI50 Response (Double-blind Treatment)
49.2; 30.2; 24.2
SECONDARY
Percentage of Participants Achieving BASDAI50 Response (Open-label Retreatment)
98.1
SECONDARY
Percentage of Participants Achieving Inactive Disease Status (Double-Blind Treatment)
85.7; 84.1; 61.3
SECONDARY
Percentage of Participants Achieving Inactive Disease Status (Open-label Retreatment)
90.6
SECONDARY
Percentage of Participants Who Experienced an Adverse Event (AE) in Period 2
46.0; 46.9; 32.3; 41.3
SECONDARY
Percentage of Participants Who Discontinued Study Treatment Due to an AE in Period 2
0.0; 4.7; 1.6; 0.0

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 = 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03253796) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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