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Rheumatoid Arthritis

Pharm-Olam was contracted to rescue a double-blind, placebo-controlled, randomized, single ascending dose (4 levels) study, to evaluate the safety and tolerability of a biological monoclonal antibody to characterize the PK profile and to investigate the effects of the study compound on measures of disease activity in subjects with active rheumatoid arthritis. Another CRO was running the study in the UK, but after 6 months only 21 patients were randomized using 12 sites.

Pharm-Olam recommended 10 sites in Eastern Europe and quickly started regulatory approval. Ultimately, Pharm-Olam delivered 98 out of the required 119 patients, more than 75% of all patients, despite the fact that the other CRO had more sites and 6 months longer to recruit patients.