BIOmarker-driven DEcision Study with Adalimumab (BIODESA)

Completed

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases; Other rheumatoid arthritis

• Registration Number: ISRCTN61158084
• Lead Sponsor: niversity Hospital Regensburg (Universitätsklinikum Regensburg) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Rheumatoid arthritis (RA) is diagnosed according to the American College of Rheumatology criteria
2. Both males and females, age must be 18 years or older
3. Patients must have given written informed consent
4. The disease duration should be less than 24 months
5. The DAS28 score must be above 5.0
6. The number of swollen joints must be >=8
7. The number of tender joints must be >=10
8. The erythrocyte sedimentation rate must be >=28 mm/hour

Exclusion Criteria

1. Other inflammatory arthropathies such as psoriasis arthritis and similar conditions
2. Treatment with disease modifying anti-rheumatic drugs (DMARDs), glucocorticoids, or biologics
3. Severe or uncontrolled co?morbidities (e.g. infectious, metabolic, hepatic, cardiac, malignant, psychiatric co?morbidities)
4. A positive screening test result for tuberculosis (purified protein of tuberculin 5 [PPD5] test, chest radiography). Patients at high risk for tuberculosis are excluded or are treated with isoniazid up to 300 mg/day concomitantly.
5. Patients of child-bearing potential without adequate contraceptive protection
6. Patients with contraindications for trial drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified