Comparing the effectiveness of our tailor-made management approach for rheumatoid arthritis with routine care from a clinical, patient, as well as economic point of view

Phase 3

Active, not recruiting

• Conditions: Rheumatoid arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN16170070
• Lead Sponsor: Erasmus University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-27
• Last Update Posted: 8 January 2024
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Newly diagnosed, DMARD-naive RA patients, according to 2010 criteria
2. Between 18 and 80 years of age
3. Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter as in standard practice

Exclusion Criteria

1. Current or previous treatment of arthritis with DMARDs
2. Glucocorticoids (GCs) in the 3 months prior to randomization
3. (Relative) contraindications for study medication:
3.1. Evidence of ongoing infectious or malignant process obtained within 3 months prior to screening and evaluated by a qualified health care professional
3.2. Pregnant or nursing (lactating) women
3.3. Female participants of child bearing potential and male participants whose partner is of child bearing potential who are not willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter as in standard practice.
3.4. History of clinically significant liver disease or liver injury as indicated by abnormal liver function tests (LFT) such as aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/ serum glutamic pyruvic transaminase (ALT/SGPT), alkaline phosphatase, or serum bilirubin. The Investigator should be guided by the following criteria: Any single parameter may not exceed 2 x upper limit of normal (ULN). A single parameter elevated up to and including 2 x ULN should be re-checked once more as soon as possible, and in all cases, at least prior to enrollment/randomization, to rule out laboratory error
3.5. History of renal trauma, glomerulonephritis, or subjects with one kidney only, or a glomerular filtration rate (GFR) < 30 ml/min.
3.6. Other underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunomodulatory therapy
4. Unable to understand, speak and write in Dutch

Study & Design

• Study Type: Interventional
• Study Design: Not specified