Randomised Efficacy and Discontinuation Study of Etanercept and Adalimumab (RED SEA): A pragmatic open label study in rheumatoid arthritis

Completed

• Conditions: Musculoskeletal Diseases: Rheumatoid arthritis (RA); Musculoskeletal Diseases; Rheumatoid arthritis (RA)

• Registration Number: ISRCTN95861172
• Lead Sponsor: niversity Hospital Birmingham NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

The participants will be patients with rheumatoid arthritis who attend the Rheumatology Outpatients Department at Selly Oak, City or Solihull Hospitals in Birmingham and St Mary's Hospital, Newport, Isle of Wight. They will be identified as likely to fulfill NICE criteria for receiving a TNF-inhibitor and will be provided with written information about this study and these drugs. Patients will then attend a hospital clinic where their Disease Activity Score (DAS) will be measured, to ensure they meet National criteria. Their medical history will be reviewed at that clinic visit to ensure that there are no contra-indications to them receiving a TNF
inhibitor. In addition any screening procedures for tuberculosis or any other areas of clinical concern will be
completed. At this time, in cases where patients or clinicians have a strong preference for a particular TNF
inhibitor (any one of adalimumab, etanercept or infliximab), a plan of treatment will be agreed with patients.
Other patients - we believe a majority of those eligible for a TNF inhibitor - will be asked whether they are willing to be involved in this study. It will be explained to them that, in the study, they will be randomly allocated to adalimumab or etanercept. The study and drug information leaflets will be discussed in detail and any questions answered. All patients will have had the opportunity to think about their treatment options for at least 24 hours by this time. A consent form will be completed for patients willing to be involved.

1. Men and women over the age of 18 years with rheumatoid arthritis meeting international disease
classification criteria.
2. NICE Criteria for treatment with TNF inhibitors in regard to lack of response to at least two DMARDs (one of which must be methotrexate at adequate doses and for a defined period of time - according to NICE criteria).
3. Willing to enter study and able to understand the procedures and comply with the study protocol

Exclusion Criteria

1. Any condition(s) which, in the opinion of the physician caring for the patient, makes that patient unsuitable for a TNF inhibitor for their arthritis
2. Any individual unable to understand study procedures or unwilling to comply
3. Previous treatment with any licensed or experimental biological TNF inhibitor

Study & Design

• Study Type: Interventional
• Study Design: Not specified