A phase II randomized, double-blind, multicentre, placebo-controlled, dose-ranging, parallel group study to compare the efficacy, safety and tolerability of 3 strengths of AD 452 in adult subjects with active rheumatoid arthritis who are currently taking methotrexate

Arakis Ltd0 个研究点目标入组 292 人开始时间: 2005年7月26日最近更新: 2012年4月24日

适应症

试验速览

暂无简介。

•1. Male or female
•2. Aged 18 - 75
•3. Documented diagnosis of rheumatoid arthritis (RA) ACR functional classes I-III, onset must be after age 16 years.
•4. RA must have been present for at least 6 months.
•5. Taking methotrexate for at least 6 months with a weekly dose between 10-25 mg (or 7.5mg if a higher dose was not tolerated) and the dose must have been stable for the last 8 weeks.
•6. At least 4 (out of 28) tender/painful and swollen joints and a CRP= 4 mg/L.
•7. Low dose glucocorticoid (=10 mg prednisolone equivalent), NSAIDs, COX-2 inhibitors, codeine are allowed but must have been taken at a stable dose for 4 weeks.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Pregnant or breastfeeding
•2. History of other inflammatory joint disease or any arthritis with onset prior to age 16 years
•3. Require halofantrine, mefloquine, any known disease modifying therapy (DMARD)
•4. QTc >470ms
•5. Any of the following conditions:
•Diabetes mellitus, history/current therapy for lymphoma, leukaemia, malignant melanoma, active infection, known HIV, positive serology for hepatitis B or C, history of cardiac conduction disorders, significant hepatic or renal insufficiency, clinically significant abnormal laboratory parameters (not including CRP), sensitivity to antimalarial or related compounds or active depression or recent history of depression, generalised anxiety disorders or convulsions.

发起方

Arakis Ltd