Complex Rheumatoid Arthritis Phase IIb trial

We partnered with a global clinical research organisation to conduct a complex phase IIb, 12 week Randomized, double blind, Parallel group, Placebo-Controlled study to evaluate efficacy, safety and tolerability of different dosage regimens of IMP in patients with Active Rheumatoid Arthritis who have had inadequate response to comparator. The IMP was an orally active, potent and selective phosphodiesterase 4 inhibitor (PDE 4) which is being developed as potential treatment for chronic inflammatory disorders such as rheumatoid arthritis (RA), asthma and inflammatory bowel diseases (e.g. ulcerative colitis (UC)).

Globally, approximately 406 patients will be randomized (1:2:2:2) to receive treatment with IMP (2 mg, 4 mg,6 mg) or placebo. The study was conducted in global centers of excellence including UK and Poland. Sri Lanka has contributed 50 patients from 5 centers in very short period.

Key considerations:

• 5 centers
• 50 patients
• 12 weeks from feasibility to first patient in
• within the agreed recruitment period
• No major or critical audit finding from CRO and Sponsor