EUCTR2016-002337-30-DE进行中（未招募）1 期
A 12 WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL GROUP, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY PROFILE OF PF-06650833 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH AN INADEQUATE RESPONSE TO METHOTREXATE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 269
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 and female (including WOCBP) subjects between the ages of 18 and 75 years, inclusive. For subjects >70 years old, the site must discuss subject eligibility with the study team to ensure that these subjects are sufficiently healthy to participate.
- •2.Diagnosis of RA and meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA with a Total Score =6/10.
- •3.The subject has active disease at both Screening and Baseline, as defined by both:
- •=6 joints tender or painful on motion, AND
- •=6 joints swollen;
- •and fulfills 1 of the following 2 criteria at Screening:
- •High sensitivity C reactive protein (hsCRP) >7 mg/L at screening
- •Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr;
- •4. Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.
- •5. Subjects must be seropositive at the time of randomization (ACPA positive).
- •6. Subjects must have been taking oral or equivalent parenteral (IM or SC, only; IV administration is not permitted) MTX for at least 3 months (prior to baseline randomization) at an adequate dose to determine that the subject had an inadequate response to MTX
- •7. Up to 50 % of subjects may have received one (and only one) approved TNF-inhibiting biologic agent administered in accordance with its labeling recommendations. The TNF-inhibiting biologic could have been discontinued due to its being deemed inadequately effective and/or not tolerated.
- •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 210
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Subjects with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
- •2. Subjects with any of the following infections or infections history:
- •a. Any infection requiring treatment within 2 weeks prior to screening (Visit 1).
- •b. Any infection requiring hospitalization, parenteral antimicrobial therapy within 60 days, or as otherwise judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months.
- •c. Infected joint prosthesis at any time with the prosthesis still in situ.
- •d. Recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
- •e. Subjects will be screened for HIV (unless local regulations prohibit
- •mandatory testing). Subjects who test positive for HIV will be excluded from the study.
- •f. Subjects will be screened for hepatitis B virus infection and will be excluded if positive for hepatitis B surface antigen (HBsAg). Subjects with HbsAg negative testing but who test positive for hepatitis B core antibody (HBcAb) must have further testing for hepatitis B surface antibody (HBsAb). If HBsAb is negative, the subject will be excluded from the study.
- •g. Subjects with clinically significant active hepatic disease or hepatic impairment by laboratory assessment.
- •h. Subjects will be screened for hepatitis C virus (HCV Ab). Subjects with positive HCV Ab tests will be reflex tested for HCV ribonucleic acid (HCV RNA). Only subjects with negative HCV Ab or HCV RNA will be allowed to enroll in the study.
- •3. Evidence of active or latent, untreated or inadequately treated infection with Mycobacterium tuberculosis (TB)
- •4. Pre-existing chronic autoimmune disease.
- •5. Subjects with fibromyalgia will be excluded.
研究者
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