Musculoskeletal Diseases: Rheumatoid arthritis (RA) Musculoskeletal Diseases Rheumatoid arthritis (RA)
Conditions
Interventions
Please note that the anticipated end date of this trial has been extended from 30 November 2007 to 30 November 2009 as of 2nd January 2008.
Background
Rheumatoid arthritis (RA) affects around 1% of
though outcomes vary greatly and early use of effective treatments is important for reducing the impact of disease. Disease can be effectively suppressed, but not cured, by Disease Modifying Anti-Rheu
Sponsors
University Hospital Birmingham NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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. Inclusion criteria: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportions of patients still taking adalimumab and etanercept one year after starting treatment. Patients will be deemed to be still on treatment if an injection of adalimumab or etanercept has been used 12 months after starting therapy, with a window of 2 weeks either side of the 12 month anniversary. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportions of patients still taking etanercept and adalimumab 6 months after starting treatment (definition for continued drug use as for primary outcome). 2. Disease activity score (DAS28) assessed 12 to 16 weeks after starting treatment. 3. Adverse effects defined by severity. 4. Proportions of patients discontinuing therapy for different reasons classified as lack of efficacy; toxicity; both; other reasons. Classification to be agreed by two investigators. 5. Satisfaction with medication assessed with the Treatment Satisfaction Questionnaire for medication (vII) assessed 12 to 16 weeks and one year after starting treatment. 6. Changes in concomitant medication at 12 months (± 2 weeks) from a review of medical records and patient interview. | — |
Countries
United Kingdom
Outcome results
None listed