Clinical Research Directory

Inclusion Criteria: SPARTACUS Phase A: "Remission-Induction Phase" A subject will be eligible for study participation if all of the following criteria are met: * Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol. * Subjects must be between 18 and 65 years of age. * Subjects must have been diagnosed with peripheral spondyloarthritis by the treating rheumatologist. * Subjects must meet the ASAS classification criteria for peripheral spondyloarthritis: subjects must have current arthritis (asymmetric or predominantly in the lower limbs) or current enthesitis (except for enthesitis only along the spine, sacroiliac joints and/or chest wall) or current dactylitis plus at least 1 of the following SpA features: * Anterior uveitis confirmed by an ophthalmologist (past or present) * Crohn's disease or ulcerative colitis diagnosed by a gastroenterologist (past or present). * Evidence of preceding infection (acute diarrhea or non-gonococcal urethritis or cervicitis 1 month before arthritis). * Psoriasis diagnosed by a dermatologist (past or present). * HLA B27 positivity * Sacroiliitis by imaging defined as bilateral grade 2-4 or unilateral grade 3-4 sacroiliitis on plain radiographs, according to the modified New York criteria or active sacroiliitis on MRI according to the ASAS consensus definition (ref of addendum). * Subjects must have had onset of peripheral SpA symptoms ≤12 months prior to the screening visit. * Subjects must have active disease at screening defined by Patient Global Assessment of Disease Activity Numerical Rating Scale (NRS) ≥ 4 and Patient Global Assessment of Pain NRS ≥ 4. At the baseline visit patients will be clinically evaluated to exclude spontaneous clinical remission. * In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms must be the predominant symptoms at study entry based on the Investigator's clinical judgment. * Subjects must have a negative PPD test (or equivalent) and chest radiography (anteroposterior and lateral view) at screening. If the subject has a positive PPD test (or equivalent), has had a past ulcerative reaction following PPD placement and/or a chest radiography consistent with prior TB exposure, the subject must initiate, or have documented completion of a course of anti-TB therapy. * Women of childbearing potential or men capable of fathering children must be using adequate birth control measures during the study and for 3 months after receiving the last administration of study agent. * Subject is judged to be in good health as determined by the principal investigator based upon the results of medical history, physical examination, laboratory profile, and chest x-ray (CXR) performed during screening. * Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections. SPARTACUS Phase B: "Drug-Free Remission Phase" A subject will be eligible for phase B of the study if all of the following criteria are met: * Subjects must have participated in SPARTACUS Phase A. * Subjects must have reached a status of sustained clinical remission (defined as absence of clinical arthritis, enthesitis and dactylitis at 2 consecutive 'major' visits with an interval of 12 weeks). Exclusion Criteria: * Medical history of inflammatory arthritis of a different etiology than peripheral spondyloarthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout, …). * Prior adequate treatment with methotrexate and/or sulphasalazine. * Prior exposure to any biologic therapy with a potential therapeutic impact on SpA. * Treatment with any investigational drug of chemical or biological nature within a minimum of 30 days or 5 half-lives of the drug (whichever is longer) prior to the Baseline Visit. * Subject is taking or has taken prohibited medications as outlined in Table 1 without meeting the mandatory washout period(s) relative to the baseline visit. * Infection(s) requiring treatment with intravenous (iv) anti-infective agents within 30 days prior to the Baseline visit or oral anti-infectives within 14 days prior to the baseline Visit. * Have a known hypersensitivity to human immunoglobulin proteins or other components of golimumab. * History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease. * History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB. * (History of) chronic heart failure, including medically controlled, asymptomatic CHF. * History of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. * Have received any live virus or bacterial vaccination within 3 months prior to the first administration of study agent; patients who are expected to receive such vaccinations during the trial, or within 3 months after the last administration of study agent. * Positive serum pregnancy test at screening. * Female subjects who are breast-feeding. * Clinically significant abnormal screening laboratory results as evaluated by the Investigator. * Positive anti-cyclic citrullinated peptide (anti-CCP) antibody at screening if the titers are crossing 3 times the upper limit of normal. * Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study. * Subject with current symptoms of fibromyalgia that would confound evaluation of the patient.