Efficacy and safety of rituximab in patients with rheumatoid arthritis - FIRST

Roche Pharma AG0 sites300 target enrollmentJune 16, 2006

Overview

No summary available.

Registry

who.int

Start Date

June 16, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Age 18 to 80
•Active rheumatoid arthritis (DAS 28 \=3\.2\)
•SJC \=4 at screening and baseline
•TJC \=4 at screening and baseline
•Patients with rheumatoid arthritis for at least 6 month diagnosed according to the revised 1987 ACR criteria for the classification of rheumatoid arthritis
•Not more than one TNFa\- inhibitor in history
•Inadequate response to either etanercept (Enbrel) or infliximab (Remicade) or adalimumab (Humira). Inadequate response is defined as either a lack of response to the respective drug or loss of response to the respective drug or intolerance to the respective drug. Etanercept treatment must have been stopped at least 4 weeks prior to first rituximab infusion, treatment with infliximab or adalimumab at least 8 weeks prior to first rituximab in\-fusion.
•Willingness and capability to give written informed consent, written consent for data protection (legal requirement in Germany: datenschutzrechtliche Einwilligung) and willingness to participate and to comply with the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•Exclusion criteria related to RA
•Functional class IV as defined by the ACR classification of Functional Status in Rheuma\-toid Arthritis.
•Exclusion criteria related to general health conditions
•Patients with other chronic inflammatory articular disease or systemic autoimmune dis\-ease, e.g. Systemic lupus erythematosus, Sjögren’s syndrome, active rheumatoid vascu\-litis, a history of systemic diseases associated with arthritis, chronic fatigue syndrome
•Any active infection, a history of recurrent clinically significant infection, a history of re\-current bacterial infections with encapsulated organisms
•Primary or secondary immunodeficiency
•History of cancer with curative treatment not longer than 5 years ago except basal\-cell carcinoma of the skin that had been excised
•Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
•Neuropathy that can interfere with quality of life and/or pain assessment.
•Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.