Extrait

Background and study aims Rheumatoid arthritis is a long-term condition causing pain, swelling and stiffness in the joints. The main aim of this study is to find out how much of the drug seliciclib can be given to patients with Rheumatoid Arthritis (RA) who have active RA despite treatment with anti-TNF monotherapy. Who can participate? Adult patients with rheumatoid arthritis can take part. What does the study involve? In stage 1, patients are grouped into seven groups of three patients each. They will receive 200mg, 400mg, 600mg, 800mg or 1000mg seliciclib once daily for 4 consecutive days every week for 4 cycles. This will find out the maximum dose of seliciclib for stage 2. In stage 2, 18 participants will receive seliciclib (at the dose found in stage 1) for twelve cycles. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? The trial will run at Newcastle, Birmingham and Glasgow, UK When is the study starting and how long is it expected to run for? October 2014 to June 2017. Who is funding the study? Medical Research Council (MRC) (UK) Who is the main contact? Miss Amy Cranston [email protected]

Critère d'inclusion

• Topic: Musculoskeletal disorders; Subtopic: Musculoskeletal (all Subtopics); Disease: Musculoskeletal

Liens

• isrctn
• ictrp