Phase 4
Completed N=323
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).
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
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Efficacy and safety of golimumab in patients with non-radiographic axial spondyloarthritis: a withdrawal and retreatment study (GO-BACK).
Outcome Measures
| Outcome | Result | p-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
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.