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

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