Tranilast plus Methotrexate vs MTX Alone in Patients with Active RA

• Research type

  Research Study

• Full title

  A Phase II, Randomized Multi-Centre, Double-Blind Study of Tranilast with Concomitant Methotrexate (MTX) Compared to MTX Alone in Patients with Active Rheumatoid Arthritis (RA).

• IRAS ID

  17315

• Contact name

  Peter C Taylor

• Sponsor organisation

  Nuon Therapeutics Inc. Contact - Michael Kitt MD

• Eudract number

  2008-006917-25

• ISRCTN Number

  not issued

• Research summary

  This is an international, multicenter, Phase II, randomized, double-blind, parallel-group study in subjects with active Rheumatoid Arthritis (RA) (active disease: =8 tender and =6 swollen joint counts and elevated CRP or ESR levels) receiving concomitant methotrexate (MTX). The primary objective is to evaluate the efficacy of tranilast at two different dosages compared to placebo in subjects with active RA when added to continuing MTX therapy, in addition the safety and tolerability of the 3 treatment options will be assessed.It is anticipated that approximately 250 subjects (targeting 70 evaluable subjects per treatment group) will be enrolled into this study. Approximately 36 of these subjects will participate in an intensive pharmacokinetic (PK) sub-study to evaluate the pharmacokinetics of tranilast and MTX. A further 36 subjects will participate in an ultrasound imaging and biomarker sub-study to investigate the effects of tranilast on synovial vascularity, this will take place at The Kennedy Clinical Trials Unit, Charing Cross Hospital.Subjects will participate in the study for approximately 20 weeks: up to 4 weeks for screening followed by 12 weeks of treatment (tranilast or placebo) and a final follow-up visit 4 weeks after their last dose of study drug. At the baseline visit subjects will be randomized to one of three treatments groups (1:1:1): tranilast 75 mg BID (150 mg/day), tranilast 150 mg BID (300 mg/day), or placebo. The number of subjects enrolled with a history of previous RA treatment with biologics (including TNF-alpha inhibitors, T cell inhibitors and B cell inhibitors) will be limited to 30% of all subjects enrolled. All subjects will continue MTX at the same dose utilized prior to study entry.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/26

• Date of REC Opinion

  22 Apr 2009

• REC opinion

  Further Information Favourable Opinion