NCT01029613CompletedNot Applicable
Adalimumab in Rheumatoid Arthritis. An Investigation of Changes in Disease Activity and Course of Joint Destruction by Use of 3 Tesla Whole-Body MRI, Dedicated 3 Tesla MRI and CT of the Hand, and Soluble Biomarkers
Glostrup University Hospital, Copenhagen8 sites in 1 country40 target enrollmentStarted: December 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 8
- Primary Endpoint
- EULAR response criteria
Study Overview
Brief Summary
Adalimumab in rheumatoid arthritis. An investigation of changes in disease activity and course of joint destruction by use of 3 Tesla Whole-Body MRI, dedicated 3 Tesla MRI and CT of the hand, and soluble biomarkers. Furthermore to compare ultrasound examination with wholebody MRI etc.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > 18 years old and < 85 years old
- •RA in accordance with American College of Rheumatology 1987 criteria
- •Moderate or highly active RA defined as DAS28 > 3,2 (CRP based)
- •Clinical indication for TNF-α inhibitor treatment by the treating physician
- •No contraindications for TNF-α inhibitor treatment
- •No contraindications for MRI
- •Serum creatinine in normal range
- •Sufficient contraception for fertile women
- •Capable of giving informed consent
- •Capable of complying with the examination program of the protocol
Exclusion Criteria
- •Other DMARDs than MTX from less than 4 weeks before inclusion and throughout the study period
- •Cyclophosphamide, Chlorambucil or other alkylating agents from less than 4 weeks before inclusion and throughout the study period
- •Intramuscular or intravenous injection of glucocorticoid from less than 4 weeks before inclusion and throughout the study period
- •Pregnancy wish, pregnancy or breast-feeding
- •Contraindications for TNF-α inhibitor treatment
- •Contraindications for MRI
- •Known recent drug or alcohol abuse
- •Failure to provide written consent
- •Incapable of complying with the examination program for physical or mental reasons
Arms & Interventions
Rheumatoid arthritis
Intervention: Adalimumab (Drug)
Outcomes
Primary Outcomes
EULAR response criteria
Time Frame: 16 weeks
Secondary Outcomes
- Number of joints with inflammation on MRI(16 and 52 weeks)
- Erosions on X-rays and CT(52 weeks)
- Biomarkers(16 and 52 weeks)
Investigators
MOstergaard
Professor
Glostrup University Hospital, Copenhagen
Study Sites (8)
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