Remission Induction in Very Early Rheumatoid Arthritis: a comparison of etanercept plus methotrexate plus steroid with standard therapy

Record Provided by the NHSTCT Register - 2007 Update - Department of Health0 sites20 target enrollmentSeptember 28, 2007

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Enrollment: 20
Status: Completed
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

September 28, 2007

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Sponsor

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

•Patients with very early synovitis of less than 12 week duration will be identified via the rapid access early arthritis clinics run at the participating centres. Patients fulfilling clinical inclusion criteria and not meeting exclusion criteria will have measurements of their serum levels of rheumatoid factor and anti\-CCP antibody and will be given an information sheet on the study. They will be asked to attend for follow up review after 2\-7 days. Those patients who are seropositive for both rheumatoid factor and anti\-CCP antibody will be invited to participate in the trial.
•1\. Age over 18 years
•2\. Synovial swelling of at least 1 joint confirmed by clinical assessment
•3\. Seropositivity for RF and anti\-CCP Ab
•4\. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study
•5\. Female subjects of childbearing potential must test negative for pregnancy
•6\. Patients should be able to give informed consent to study entry

•1\. Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of \>1 hour) of \>12 weeks
•2\. Previous history of inflammatory arthritis
•3\. Previous use of DMARDs or anti\-TNF\-agents
•4\. Any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders)
•6\. A history or other evidence of latent or active granulomatous infection, including TB, histoplasmosis or coccidioidomycosis, prior to study entry
•7\. Administration, or expected administration, of any live virus or bacterial vaccination within 3 months before the first administration of study agent or during the trial
•8\. A history of an infected joint prosthesis, or administration of antibiotics for a suspected infection of a joint prosthesis, if that
•prosthesis has not been removed or replaced
•9\. Known infection with HIV, hepatitis B, or hepatitis C
•10\. A serious infection that in the opinion of the investigator precludes receipt of a TNF blocking agent