A Randomized, Double-blind, Placebo-controlled, Parallel Group, Exploratory Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Adults with Active Rheumatoid Arthritis who have demonstrated an inadequate Response to anti-TNF therapy.

Applied Molecular Transport Inc.0 个研究点目标入组 20 人开始时间: 2020年11月4日最近更新: 2022年3月28日

适应症

试验速览

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•Female and male patients aged =18 and <75 years old, inclusive at the time of informed consent.
•Body weight of = 45 kilograms (kg) and =100 kg and must have a body mass index (BMI) within the range of 18.5 – 34.9 kg/m2.
•Diagnosed with RA under the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) criteria for at least 6 months before.
•Patients must be taking anti-TNF biologic treatment under approved dosage and administration for =12 weeks and < 3 years but only had an inadequate response according to Investigator judgement a) DAS28(CRP) > 4.4 and = 5.1 or b) DAS28(CRP) = 3.2 and = 5.1 plus at least 2/28 swollen and tender joints (except joint surgery).
•History of biologics treatment should be limited to anti-TNF agents among adalimumab, infliximab, golimumab, etanercept, certolizumab (including biosimilars).
•Two or more swollen and tender joints in the Screening Phase (out of 28 joints).
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•Any history or complication of an inflammatory arthritic disorder other than RA
•Any history of Inflammatory Bowel Disease (Ulcerative Colitis or Crohn’s disease)
•Meets the ACR 1991 Revised Criteria for the Classification of Global Functional Status in RA Class IV.
•Received IV Immunoglobulin (IV Ig) preparations or blood products within 24 weeks before starting the study treatment.
•Received a live vaccine within 12 weeks before starting the study treatment, or is planning to receive a live vaccine during the study
•Current therapy with any non-MTX synthetic small-molecule DMARD (including but not limited to sulfasalazine, azathioprine, hydroxychloroquine, and/or leflunomide) for at least 1 month prior to the Screening Visit or concomitantly during the trial.

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