Rheumatoid Arthritis Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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-a inhibitor treatment by the treating physician - No contraindications for TNF-a 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-a 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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Denmark | Dep. of medicine, Herlev Hospital | Copenhagen | |
Denmark | Dep. of Radiology, Herlev Hospital | Copenhagen | |
Denmark | Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals | Copenhagen | |
Denmark | Dep. of Rheumatology, Gentofte Hospital | Copenhagen | |
Denmark | Dep. of Rheumatology, Glostrup Hospital | Copenhagen | |
Denmark | Dep. of Rheumatologym Glostrup Hospital | Copenhagen | |
Denmark | Dep. of Rheumatology, Helsingør Hospital | Hørsholm | |
Denmark | Dep. of Rheumatology, Køge Hospital | Køge |
Lead Sponsor | Collaborator |
---|---|
Glostrup University Hospital, Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EULAR response criteria | 16 weeks | No | |
Secondary | Number of joints with inflammation on MRI | 16 and 52 weeks | No | |
Secondary | Erosions on X-rays and CT | 52 weeks | No | |
Secondary | Biomarkers | 16 and 52 weeks | No |
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