Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (GO-BACK) (MK-8259-038)
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Intervention: Golimumab; Placebo
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.; Injections of matching placebo for golimumab.
Intervention MeSH terms: Golimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

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.
    

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:

               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