This case study outlines a Phase IIa randomised double-blind, placebo-controlled, multi-centre study to evaluate the efficacy, safety, and tolerability of a study drug when given methotrexate (MTX) to subjects with active rheumatoid arthritis (RA) that have had an inadequate response to conventional disease-modifying antirheumatic drug therapies (DMARD).

After an impressive bid defence, a major PRA client awarded a rheumatoid arthritis study contract based on PRA’s strategy for achieving first-patient-in (FPI) by the end of the calendar year.

PRA’s plan depended on a closely managed project with clear timelines and responsibilities, as well as selecting key sites that could support its goal.

During the ethics committee (EC) submission process, last-minute revisions to the subject questionnaire and a protocol amendment caused PRA to miss the established EC milestone. In addition, PRA would have to screen patients during the December holiday season, and there were delays with the investigational product/supply shipments.