EUCTR2015-005308-27-CZ进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 3
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 368
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female subjects =18 years of age
- •2.Subjects willing and able to sign informed consent
- •3.Subjects must have a diagnosis of adult onset RA classified by ACR/EULAR 2010 revised classification criteria for RA for at least 24 weeks prior to Screening.
- •If the subject was diagnosed according to ACR 1987 criteria previously, the Investigator may classify the subject per ACR 2010 retrospectively, using available source data.
- •4.Treatment with oral, SC, or intramuscular (IM) MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or =10 mg/week if there is documented intolerance to higher doses)
- •The dose and means of administering MTX must have been stable for at least 6 weeks prior to Screening.
- •5.Subjects must have moderately to severely active RA disease as defined by all of the following:
- •a.=6 tender joints (68 joint count) at Screening and baseline; and
- •b.=6 swollen joints (66 joint count) at Screening and baseline; and
- •c.CRP above ULN at Screening based on the central laboratory results
- •6.Subjects must have a documented inadequate response to treatment (i.e., TNFi failure) with =1 licensed TNFi following at least 12 weeks of therapy with that agent. Inadequate response to treatment is classified as either:
- •a.Primary failure: The absence of any documented clinically significant response; or
- •b.Secondary failure: Documented initial response with subsequent loss of that response or partial response
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Diagnosis of any other inflammatory arthritis or systemic rheumatic disease •However, subjects may have secondary Sjogren’s syndrome or hypothyroidism.
- •2.Subjects who are Steinbrocker class IV functional capacity (incapacitated, largely or wholly bed ridden or confined to a wheelchair, with little or no self care)
- •3.Prior exposure to any licensed or investigational compound directly or indirectly targeting IL 6 or IL 6R (including Janus kinases and spleen tyrosine kinase [SYK] inhibitors)
- •4.Prior treatment with cell depleting therapies, including anti CD20 agents or investigational agents (e.g., CAMPATH, anti CD4, anti CD5, anti CD3, and anti CD19), with the exception of rituximab, which is allowed with a washout period of 24 weeks prior to baseline.
- •5.Use of parenteral and/or intra articular glucocorticoids within 4 weeks prior to baseline
- •6.Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline
- •7.Prior history of no response to hydroxychloroquine and sulfasalazine
- •8.Prior use of cDMARDs other than MTX is allowed with the following washout periods to be completed prior to baseline:
- •a.4 weeks for sulfasalazine, azathioprine, cyclosporine, hydroxychloroquine, chloroquine, gold, penicillamine, minocycline, or doxycycline
- •b.12 weeks for leflunomide unless the subject has completed the following elimination procedure at least 4 weeks prior to baseline: Cholestyramine at a dosage of 8 grams 3 times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times a day for at least 24 hours
- •c.24 weeks for cyclophosphamide
- •9.Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study
- •10.Participation in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline
- •Please refer to the Protocol for the full list of exclusion criteria
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