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 enrollmentDecember 2009

ConditionsRheumatoid Arthritis

InterventionsAdalimumab

DrugsAdalimumab

Overview

Phase: Not Applicable
Intervention: Adalimumab
Conditions: Rheumatoid Arthritis
Sponsor: Glostrup University Hospital, Copenhagen
Enrollment: 40
Locations: 8
Primary Endpoint: EULAR response criteria
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

July 2013

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Glostrup University Hospital, Copenhagen

Responsible Party

Principal Investigator

MOstergaard

Professor

Glostrup University Hospital, Copenhagen

Eligibility 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