A phase Ib double-blind, placebo-controlled, randomized, dose-escalating trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoind arthritis (RA) on treatment with methotrexate. - PRIORA

Takeda0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 12

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1. Out-patients with active RA with low to moderate disease activity (DAS28 >= 2.6 and <= 5.1).
•2. Patients must be on stable doses of MTX >= 7.5 and <= 25 mg/week for at least 12 weeks before the first injection of IMP, with appropriate folic acid supplementation.
•3. Age >= 18 years at screening.
•4. Body weight >= 50 kg at screening; BMI >= 18.0 and <= 30.0 kg/m2 at screening.

排除标准

•1. The use of any medication, including local injections with gold or corticosteroids, over-the-counter medication and prescription anti-rheumatic naturopathic medicines/phytopharmaca (herbs) with immunomodulatory effect, except for the allowed concomitant medication, within 2 weeks, or within less than 10 times the half-life of the respective drug, or within the duration of its pharmacodynamic effect before the first injection (whichever is longer), as well as the anticipated use of disallowed concomitant medication between the first injection and EoT/ET visit.
•2. Previous use of any GM-CSF treatment and/or any treatment antagonising GM-CSF or its receptor at any time in the past.
•3. The use of biological agents (as experimental therapy or not) within (whichever is longer):
•- 10 times the respective half-life before the first injection of trial medication.
•- the continuation of the pharmacodynamic effects of the respective agent before the first injection of trial medication.
•- 3 months before the first injection of trial medication in case of TNF inhibitors.
•- 12 months for any cell depleting therapies (after B-cell depleting therapy, B-cells must have returned to normal values before screening).
•4. The use of the oral DMARD leflunomide within 12 weeks before the first injection of trial medication, or within 4 weeks before first injection of trial medication if supportive oral cholestyramine (>= 8 g/tid) or charcoal (>=50g/qds) washout treatment is/was given.
•5. Chronic use of prophylactic or suppressive antibiotic, antifungal or antiviral agents.
•6. The use of intra-muscular, intravenous or intra-articular corticosteroids within 4 weeks before the first injection of trial medication.

研究者

发起方

Takeda

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