The primary objective of this study is to evaluate the efficacy and safety of CDP6038
administered subcutaneous (sc) at various doses compared to placebo.
Biological: Olokizumab 60 mg
Biological: Olokizumab 120 mg
Biological: Olokizumab 240 mg
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Locations near you
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Full eligibility criteria for NCT01463059
Ages eligible for Study
20 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
Must have moderately to severely active RA disease as defined by ≥6 tender joints
(68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR
Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception
Have a diagnosis of any other inflammatory arthritis
Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
Subjects with known concurrent acute or chronic viral hepatitis B or C infection
Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
Subjects with known history of or current clinically active infection
Subjects at high risk of infection
Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening
All locations for NCT01463059
Korea, Republic of (5)
Daejeon, Korea, Republic of
Jung-gu, Korea, Republic of
Seongdong-gu, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Gangnam-Gu, Korea, Republic of
View full eligibility
Tris trial is registered with FDA with number: NCT01463059. The sponsor of the trial is UCB Japan Co. Ltd. and it is looking for 119 volunteers for the current phase.
Official trial title: A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy
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