EUCTR2015-005309-35-GB进行中（未招募）1 期
A Multicenter, Open-Label, Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis - Clinical Rheumatoid Arthritis Development for Olokizumab (CREDO) 4
R-Pharm0 个研究点目标入组 1,880 人开始时间: 2016年6月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,880
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. Subject must be willing and able to sign informed consent
- •2. Subject must have completed the 24-week double-blind Treatment Period in 1 of the 3 core studies (CL04041022, CL04041023, or CL04041025).
- •3. Subject must have maintained their stable dose (and route) of MTX 15 to 25 mg/week (or =10 mg/week if there is documented intolerance to higher doses) during the core study and plan to maintain the same dose and route of administration for =12 additional weeks.
- •4.Subjects must be willing to take folic acid or equivalent throughout the study.
- •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 1576
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 304
排除标准
- •1. Subject with any medically important condition in the core study (e.g., clinically significant laboratory values, frequent AEs or SAEs, infection SAEs, and/or other concurrent severe and/or uncontrolled medical condition) which would make this subject unsuitable for inclusion in the OLE study in the Investigator’s judgement.
- •2. Subject has evidence of active TB
- •3. Subject with a positive or repeated indeterminate interferon-gamma
- •release assay (IGRA) result at Week 22 of the core study
- •? Subjects may be enrolled in the OLE study if they fulfill all 3 of the
- •following criteria prior to the first dose of study treatment:
- •a. Active TB is ruled out by a certified TB specialist or pulmonologist who
- •is familiar with diagnosing and treating TB (as acceptable per local
- •b. The subject starts prophylaxis for LTBI according to countryspecific/
- •Centers for Disease Control and Prevention (CDC) guidelines
- •(treatment with isoniazid for 6 months is not an appropriate prophylactic
- •regime for this study and it should not be used); and
- •c. The subject is willing to complete the entire course of recommended
- •LTBI therapy
- •4. Subject has planned surgery during the first 12 weeks of the OLE
- •5. Female subjects who are pregnant or lactating, or who are planning to
- •become pregnant during the study or within 6 months of the last dose of
- •study treatment
- •6. Female subjects of childbearing potential (unless permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 months of natural amenorrhea as defined by the amenorrhea with underlying status [e.g., correlative age] or 6 months of natural amenorrhea with documented serum follicle-stimulating hormone levels >40 mIU/mL and estradiol <20 pg/mL) who are not willing to use a highly effective method of contraception during the study and for at least 6 months after the last administration of study treatment
- •Male subjects with partners of childbearing potential not willing to use a highly effective method of contraception during the study and for at least 3 months after the last administration of study drug treatment.
- •7. Subject is unwilling or unable to follow the procedures outlined in the protocol
- •8. Other medical or psychiatric conditions, or laboratory abnormalities that may increase the potential risk associated with study participation and administration of study treatment, or that may affect study results interpretation and, as per Investigator’s judgement, make the subject ineligible.
研究者
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