Adalimumab dose reduction aiming low serum concentration with control of disease activity
Recruiting
- Conditions
- Rheumatoid arthritis
- Registration Number
- NL-OMON24020
- Lead Sponsor
- Reade Rheumatology Research Institute
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 89
Inclusion Criteria
Rheumatoid arthritis patient, according to ACR 1987 ACR/EULAR 2010 criteria
Treated for at least 28 weeks with adalimumab
Adalimumab trough concentration >5mg/L
Who has agreed to participate (written informed consent);
Age 18 years or older.
Exclusion Criteria
Scheduled surgery during the follow-up of the study or other pre-planned reasons for treatment discontinuation
Life expectancy shorter than follow-up period of the study;
No other disease that might flare if adalimumab is tapered like psoriasis, inflammatory bowel disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to evaluate the disease activity after dose reduction, aiming adalimumab concentration of 2 mg/L or 5 mg/
- Secondary Outcome Measures
Name Time Method The secondary objectives are to evaluate whether reducing adalimumab dose aiming a concentration of 2 mg/L is superior in costs savings compared to dose tapering aiming adalimumab concentration of 5 mg/L, to evaluate the algorithm used to achieve target concentration of 2 mg/L or 5 mg/L and to study the difference in cumulative incidence of flares between the two study groups