RheumAFooT (Rheumatoid Arthritis Foot Trial)

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN01982076
• Lead Sponsor: Medical Research Council (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Patients will be suitable for inclusion if they have a definite diagnosis of RA (satisfying the 1987 American Rheumatism Association revised criteria for RA), are between 18-80 years of age and can read and write English. Patients must also have a current history of foot impairment as determined by standard history and clinical examination techniques and a Leeds Foot Impact Scale score of =15 points. Patients must also have stable drug management in the 3 months prior to recruitment including Disease Modifying Anti-Rheumatic Drugs, Non-Steroidal Anti-Inflammatory Drugs and oral corticosteroids.

Exclusion Criteria

Patients will be excluded if they have foot problems related to and require treatment under the appropriate medical specialty such as diabetes and peripheral vascular disease. Patients will be excluded if they have severe complications of their RA resulting in active or high risk of developing foot ulceration. On medical consultation, any patient with foot problems, such as ulceration and infection, likely to complicate systematic treatment with biologic and other immunosuppressant therapy (Infliximab, Etanercept, Anakinra, Cyclophosphamide, Cyclosporin, Azathioprine and any new, including trial, biologic - even if placebo) will be excluded. Those patients who have received podiatry treatment at Leeds General Infirmary Foot Health Department in the last 3 months will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome: change in Leeds Foot Impact Scale score between baseline and 12 months.

Secondary Outcome Measures

Name	Time	Method
Disease activity score, health assessment questionnaire and walking speed were also recorded.