Planing an Early RA Prevention Trial

Pisetsky, David

Abstract

? The goal of this planning grant is to complete development of a clinical trial for primary and secondary prevention of rheumatoid arthritis (RA) and to establish the infrastructure for the performance of the trial. ? The trial is titled RAPIDT (Rheumatoid Arthritis Prevention by Immediate Definitive Therapy) and is designed to determine the impact of DMARD therapy in patients with early synovitis. The study will have 5 arms consisting of patients administered DMARD therapy (methotrexate alone or methotrexate plus infliximab) for either 3 months or 12 months, with a control arm receiving conventional therapy for 3 months. The primary outcomes will be remission at the end of treatment and remission 1 year after the cessation of therapy. As such, this trial addresses the """"""""window of opportunity"""""""" hypothesis. It is anticipated that a grant will be submitted to the NIH for a coordinating center for this trial, with other funding obtained from industry. A planning grant is proposed at this tune to finalize trial design and develop procedures of operation as well as identify sites.
Three specific aims are proposed: 1) To complete development of the protocol.
This specific aim will include finalization of the trial design, refining primary and secondary outcome measures and addressing issues of statistical analysis in a trial aimed at the induction of remission; 2) To address issues of informed consent in the context of prevention strategies for RA. Since RAPIDT is designed to be a prevention study, the informed consent process will differ from other trials on RA in the past.
This aim will consider issues of early treatment to construct an appropriate informed consent; and 3) To complete a manual of operations and procedures, implement approaches for data management and identify sites for performance.
This aim will establish the infrastructure for the trial and provide all the essential elements to allow enrollment to begin. ? ?