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

niversity Hospitals Birmingham NHS Foundation Trust0 sites20 target enrollmentSeptember 29, 2006

Overview

No summary available.

Registry

who.int

Start Date

September 29, 2006

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospitals Birmingham NHS Foundation Trust

•1\. Age over 18 years
•2\. Synovial swelling of at least 1 joint confirmed by clinical assessment
•3\. Duration of symptoms attributable to inflammatory joint disease (pain, swelling or early morning stiffness of \>1 hour) of \< 12 weeks.
•4\. Seropositivity for RF and anti\-CCP Ab
•5\. 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.
•6\. Female subjects of childbearing potential must test negative for pregnancy
•In addition,
•1\. All subjects must have provided written informed consent prior to admission to the study.
•2\. The subject must be able to understand and comply with the protocol requirements, instructions and restrictions.
•Are the trial subjects under 18? no

•1\. Previous history of inflammatory arthritis.
•2\. Previous use of DMARDs or anti\-TNF\-agents.
•3\. Any current inflammatory condition with signs or symptoms that might confound the diagnosis (e.g. connective tissue disorders).
•4\. Clinical evidence of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to study entry.
•5\. 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.
•6\. 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.
•7\. Known infection with HIV, hepatitis B, or hepatitis C.
•8\. A serious infection that in the opinion of the investigator precludes receipt of a TNF blocking agent.
•9\. Serious and uncontrolled co\-existing disease that in the opinion of the investigator preclude the use of TNF\-blocking medication, methotrexate or depomedrone (including pulmonary disease on chest radiograph, congestive cardiac failure (NYHA grade 3 or 4\), history of demyelinating disease such as multiple sclerosis or optic neuritis).
•10\. Bleeding disorder of the use of anti\-coagulants