Identification of predictive factors in synovial samples for the clinical response to tumour necrosis factor-alpha blockade in rheumatoid arthritis

Academic Medical Centre (AMC) (The Netherlands)0 sites143 target enrollmentFebruary 1, 2007

Overview

No summary available.

Registry

who.int

Start Date

February 1, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

Academic Medical Centre (AMC) (The Netherlands)

•1\. Men/women suffering from rheumatoid arthritis, based on the American Rheumatism Association (ARA) 1987 criteria, who failed at least one Disease Modifying Anti\-Rheumatic Drug (DMARD) including methotrexate, will be included in the study
•2\. Patients in ARA functional classes I, II, and III may be included
•3\. In addition the patients must fulfill the following criteria at baseline:
•a. Disease Activity Score (DAS 28\) more than 3\.2
•b. patients global evaluation of his/her rheumatoid condition assessed as fair, poor or very poor and
•investigators global evaluation of patients rheumatoid condition assessed as fair, poor or very poor
•c. more than 18 years of age and less than or equal to 85 years
•d. use concurrent methotrexate treatment (5 \- 30 mg/week; stable since at least 28 days before initiation) during the study. Subjects may be taking nonsteroidal anti\-inflammatory drugs, provided the dose and frequency have been stable for at least 28 days. Subjects may be receiving prednisone therapy of less than or equal to 10 mg/day provided that the dosage has been stable for at least two months prior to entry

•1\. Pregnancy
•2\. Breastfeeding
•3\. A history of or acute inflammatory joint disease of different origin e.g. mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus or any arthritis with onset prior to age 16 years
•4\. Acute major trauma
•5\. Previous therapy at any time with: TNF\-alpha directed monoclonal antibodies or p75 TNF receptor fusion protein
•6\. Therapy within the previous 60 days with:
•a. any experimental drug
•b. alkylating agents, e.g. cyclophosphamide, chlorambucil
•c. antimetabolites
•d. monoclonal antibodies