Quality management: improvement of patient care in recently diagnosed rheumatoid arthritis

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN72821021
• Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-20
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

1. RA, defined according to the revised American College of Rheumatology (ACR) criteria for RA
2. A disease duration of less than 1 year, estimated by the rheumatologist
3. Aged greater than 16 years
4. No previous treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs)
5. Written informed consent by the patient

Exclusion Criteria

1. Abnormal renal function (Cockroft less than 75 ml/min)
2. Abnormal liver function (Aspartate Aminotransferase [ASAT]/Alanine Aminotransferase [ALAT] greater than 2 x normal), active or recent hepatitis, cirrhosis
3. Major co-morbidities like malignancies, severe diabetic mellitus, severe infections, severe cardio and/or respiratory diseases
4. Leukopenia and/or thrombocytopenia
5. Inadequate birth control conception, pregnancy, and/or breastfeeding
6. Chronic use of oral glucocorticoids
7. Treatment with cytoxic or immunosuppressive drugs within a period of 3 months prior to the study
8. Alcohol intake greater than 2 units per day or drug abuse, presently or in the past
9. Psychiatric or mental disorders which makes adherence to the study protocol impossible
10. Taking part into another clinical trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients in remission, in which remission is defined as:<br>1. Number of swollen joints = 0 <br>2. Plus at least two out of three following criteria:<br>2.1. Number of swollen joints less than 3<br>2.2. Erythrocyte Sedimentation Rate (ESR) less than 20 mm/hr <br>2.3. Visual Analogue Scale (VAS) general well being less than 20 mm

Secondary Outcome Measures

Name	Time	Method
1. Disease activity during 1 year<br>2. Feasibility of computer assisted program in daily practice