EUCTR2019-001554-25-NL
Active, not recruiting
Phase 1
Adalimumab dose optimization in rheumatoid arthritis using therapeuticdrug monitoring (ADDORA): multi-center open label randomized controlledtrail - ADalimumab Dose Optimization in Rheumatoid Arthritis using (ADDORA)
Reade0 sites267 target enrollmentOctober 29, 2019
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Reade
- Enrollment
- 267
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-rheumatoid arthritis patient, according to ACR 1987 or ACR/EULAR 2010 criteria
- •\- adalimumab \< 16 weeks at registered dose of 40mg every other week
- •\-who has agreed to participate (written informed consent);
- •\-age 16 years or older.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 167
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 100
Exclusion Criteria
- •\-Life expectancy shorter than follow\-up period of the study;
- •\-Other disease that might flare if adalimumab is tapered like psoriasis,
- •inflammatory bowel disease.
Outcomes
Primary Outcomes
Not specified
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