Conditioning and Health Training in Rheumatoid Arthritis
- Conditions
- Pharmacological conditioning with or without an online guided health training in patients with recent-onset rheumatoid arthritis.Farmacologisch conditioneren met of zonder een online begeleide gezondheidstraining in patiënten met nieuw-gediagnosticeerde reumatoïde artritis.
- Registration Number
- NL-OMON20702
- Lead Sponsor
- eiden University
- Brief Summary
n/a
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 141
Inclusion Criteria
1.Adult (minimum age of 18 years)
2.Recent-onset rheumatoid arthritis according to the revised American College of Rheumatology (ACR) criteria
Exclusion Criteria
1.Previous therapy with DMARDs or with corticosteroids (exception: one dose of parenteral corticosteroids within the last 6 months, but not within the last 2 months, or an oral dose of prednisone of ≤ 10 mg/day for ≤ 2 weeks within the same period is allowed).
2.Pregnancy or wish to become pregnant during the study, or childbearing potential without adequate contraception.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study endpoint is the difference in the percentage of patients who achieve a drug-free<br>clinical remission (Disease Activity Score DAS < 1.6) between the combined intervention<br>groups (Conditioning group and Conditioning with Health Training group) and the<br>Control group following the tapering period (12 months after the start the of the treatment).<br>
- Secondary Outcome Measures
Name Time Method Secondary study parameters are percentage of clinical remission at 8,12, and 16 months after the start of the treatment, disease activity, cytokine parameters, and other psychological outcome measures assessed at each measuring point.