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

Glostrup University Hospital, Copenhagen

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Adalimumab

Study type: Observational

Funder types: Other

Identifiers

NCT01029613

WRAP

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Rheumatoid arthritis

Treatment:

Drug: Adalimumab