EUCTR2015-005307-83-BG进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Methotrexate Therapy - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,575
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
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 12 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. Inadequate response to treatment with oral, SC, or intramuscular (IM) MTX (as defined by protocol) for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week (or =10 mg/week if intolerant 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 be willing to take folic acid or equivalent throughout the study.
- •6. 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
- •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 1345
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 230
排除标准
- •1. Diagnosis of any other inflammatory arthritis or systemic rheumatic disease
- •(e.g., gout, psoriatic or reactive arthritis, Crohn’s disease, Lyme disease, juvenile
- •idiopathic arthritis, or systemic lupus erythematosus). 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 tofacitinib or other Janus kinases and spleen tyrosine kinase [SYK] inhibitors)
- •4. Prior treatment with any cell-depleting therapies including anti-CD20 or investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, and anti-CD19)
- •5. Prior use of bDMARDs
- •6. Use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to
- •7. Use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline
- •8. Prior documented history of no response to hydroxychloroquine and sulfasalazine
- •9. Prior use of cDMARDs (other than MTX) within the following windows prior to baseline (cDMARDs should not be discontinued to facilitate a subject's participation in the study, but should instead have been previously discontinued as part of a subject's medical management of RA):
- •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 daily for at least 24 hours
- •c. 24 weeks for cyclophosphamide
- •10. Vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study
- •Please refer to the Protocol for the full list of exclusion criteria
研究者
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