Clinical Measurement Unit - Cabrini

An open-label study of anti-TNF chimeric monoclonal antibody, infliximab (REMICADE), in the treatment of patients with active rheumatoid arthritis (RA) despite methotrexate treatment.

Investigators:  A/Prof Geoff McColl, A/Prof Rachelle Buchbinder, Dr Jane Bleasel, Dr Ranjeny Thomas, Dr Kevin Pile, Dr Paddy Hanrahan, Dr Laurie Clemens   

This is a phase IV national, multi-center, open-label, study of Remicade in the treatment of patients with active RA despite treatment with MTX. The Study Steering Committee (Australian Rheumatology Association (ARA)) will oversee the study. Fifty patients will be entered into the study, 10 per centre. The study can be discontinued prior to the scheduled duration.

The primary aim of this is to evaluate the efficacy of Remicade by measuring effect on ACR criteria for improvement in patients with severe active rheumatoid arthritis despite the use of methotrexate.

Secondary Aims are to:
1) evaluate the efficacy of Remicade by measuring changes in MRI in patients with severe active rheumatoid arthritis despite the use of methotrexate;
2) To evaluate the efficacy of REMICADE by measuring impact on quality of life in patients with severe active rheumatoid arthritis despite the use of methotrexate;
3) To monitor the safety profile of Remicade in patients with severe active rheumatoid arthritis despite the use of methotrexate.