A Multicenter, Randomized, Double-blind, Parallel Group Study of CNTO 136 (sirukumab) Administered Subcutaneously as Monotherapy Compared With Adalimumab Monotherapy, in Subjects with Active Rheumatoid Arthritis

Janssen Research & Develoment, LLC,0 个研究点目标入组 0 人开始时间: 2014年12月24日最近更新: 2023年9月4日

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试验速览

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•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

•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

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Janssen Research & Develoment, LLC,