Revamilast – Phase IIb study in Active RA

• Research type

  Research Study

• Full title

  A Phase IIb, 12 week Randomized, Double-Blind, Parallel Group, Placebo-Controlled study to evaluate Efficacy, Safety and Tolerability of 2, 4 and 6 mg of Revamilast in patients with Active Rheumatoid Arthritis who have had an inadequate response to Methotrexate

• IRAS ID

  76591

• Contact name

  Paul Emery

• Sponsor organisation

  Glenmark Pharmaceuticals SA

• Eudract number

  2011-000107-40

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Revamilast is a new drug which is being developed by Glenmark Pharmaceuticals SA with the aim of helping people with inflammatory diseases (characterised by pain, heat, redness and swelling) such as rheumatoid arthritis, asthma and other chronic inflammatory diseases. In some diseases, inflammation is caused by the excess production of some chemicals called ??cytokines?? by the body's immune system. Revamilast may reduce the production of cytokines, thereby reducing inflammation. Similar drugs being developed that have been given to patients with rheumatoid arthritis, asthma and chronic inflammatory diseases have been shown to reduce their symptoms. The aim of this study is to see if revamilast can help subjects with rheumatoid arthritis who have an inadequate response to methotrexate (another drug used to treat inflammatory diseases).

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  11/YH/0153

• Date of REC Opinion

  16 Jun 2011

• REC opinion

  Further Information Favourable Opinion