Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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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
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Has chronic back pain of ≥3 months duration by history
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Has physician-diagnosed active non-radiographic axial spondyloarthritis (nr-axSpA) with disease duration <= 5 years
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Meets one of the following criteria:
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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:
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Inflammatory back pain
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Arthritis (physician-diagnosed)
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Enthesitis (heel) physician-diagnosed (spontaneous pain or tenderness at examination of the site of the insertion of the Achilles tendon or plantar fascia)
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Dactylitis (physician-diagnosed)
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Psoriasis (physician-diagnosed)
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History of physician-diagnosed inflammatory bowel disease (IBD)
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History of uveitis confirmed by an ophthalmologist
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Good response to nonsteroidal anti-inflammatory drugs (NSAID)
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Family history of SpA (presence of ankylosing spondylitis, psoriasis, acute uveitis, reactive arthritis, or IBD)
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Elevated C-reactive protein (CRP)
- Human leukocyte antigen B27 (HLA-B27)+ gene OR
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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)
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Has elevated CRP at Screening or evidence of active inflammation in the sacroiliac joints on MRI
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Has an Ankylosing Spondylitis Disease Activity Score (ASDAS) >= 2.1 at Screening
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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
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Has an acceptable history of NSAID use
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Has no history of untreated latent or active tuberculosis (TB) prior to Screening
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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
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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
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Has bilateral sacroiliitis Grade 2 or unilateral sacroiliitis Grade 3 or Grade 4 on conventional x-rays
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Is a nursing or pregnant female, or intends to become pregnant within 6 months after receiving trial medication
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Intends to donate eggs (female participants) or sperm (male participants) while receiving trial medication or within 6 months after trial medication
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Has any clinically significant condition or situation that would interfere with the trial evaluations or participation in the trial
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Has ever received any cytotoxic drugs, including chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents
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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)
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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
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Has a history of latent or active granulomatous infection prior to Screening
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Had a nontuberculous mycobacterial infection or opportunistic infection within 6 months prior to Screening
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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
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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
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Had a history of, or ongoing, chronic or recurrent infectious disease
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Is known to be infected with human immunodeficiency virus (HIV) or seropositive for hepatitis C virus (HCV)
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Has had a chest x-ray within 2 months prior to Screening that shows an abnormality suggestive of a current active infection or malignancy
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Has a history of lymphoproliferative disease
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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)
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Has a history of known demyelinating diseases such as multiple sclerosis or optic neuritis
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Has a history of or concurrent congestive heart failure of any grade
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Has a transplanted organ (with the exception of a corneal transplant performed >= 3 months prior to baseline)
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Has current signs or symptoms of significant medical illness which could interfere with the trial, or require treatment that might interfere with the trial
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Is a user of recreational or illicit drugs or has or had a substance abuse (drug or alcohol) problem within the previous 2 years
Trial design
Primary purpose
Allocation
Interventional model
Masking
323 participants in 4 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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