Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glostrup University Hospital, Copenhagen
• Treatments: Adalimumab

Criteria

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