None listed
Conditions
Interventions
Approximately 510 subjects will be randomly assigned in a 1:1:1 ratio to receive treatment with adalimumab 40 mg SC q2w, sirukumab SC 100 mg q2w, or 50 mg q4w, with approximately 170 subjects per trea
Sponsors
Janssen Research & Develoment, LLC,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Be a man or a woman of 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) or older. 2.Have a diagnosis of RA (according to the revised 1987 criteria of the ARA5) for at least 6 months before screening. 3.Have moderately to severely active RA with at least 8 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline.4.Have previous or current treatment with MTX and are considered intolerant to MTX, and/or are considered inappropriate for treatment with MTX, and/or an inadequate responder to MTX.5.If using oral corticosteroids, must be on a stable dose equivalent to ≤10 mg/day of prednisone for at least 4 weeks prior to the first administration of study agent. 6.If using nonsteroidal anti-inflammatory drugs (NSAID) or other analgesics for RA, must be on a stable dose for at least 4 weeks prior to the first administration of study agent.7.Must not have received MTX or any other non-biologic DMARD.8.CRP ≥10.00 mg/L or ESR ≥28 mm/hr at screening.FOR MORE DETAILS PLEASE GO TO THE SECTION OF INCLUSION CRITERIAS
Exclusion criteria
Exclusion criteria: 1.Has Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.21. 2.Has ever received biologic therapy for RA..3.Has ever used tofacitinib therapy or any other JAK inhibitor.4.Has received intra-articular (IA), intramuscular (IM), or IV corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent administration.5.Has received leflunomide within 24 months before the first study agent administration and have not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable. If a drug elimination procedure is performed during screening, the M1 metabolite should be measured and found to be undetectable.6.Has received immunosuppressant agents, as follows:( please go to exclusion criteria).7.Has screening laboratory test result as follows:( please go to exclusion criteria).8.Has current signs or symptoms of severe, progressive, or uncontrolled active inflammatory arthritis other than RA,etc ( see protocol).9.Has a history of any other autoimmune rheumatic disease including SLE.FOR MORE DETAILS PLEASE GO TO THE SECTION OF INCLUSION CRITERIAS
Countries
Argentina, Brazil, Bulgaria, Chile, Colombia, Germany, Hungary, Lithuania, Mexico, Modalvia, Peru, Poland, Romania, Russian Federation, Serbia, South Africa, Spain, Ukraine, United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed