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

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Adalimumab

• Registration Number: NCT01029613
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-09
• Study First Posted: 2009-12-10
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rheumatoid arthritis	Adalimumab	-

Primary Outcome Measures

Name	Time	Method
EULAR response criteria	16 weeks

Secondary Outcome Measures

Name	Time	Method
Number of joints with inflammation on MRI	16 and 52 weeks
Erosions on X-rays and CT	52 weeks
Biomarkers	16 and 52 weeks

Trial Locations

Locations (8)

Dep. of Rheumatology, Glostrup Hospital; 🇩🇰 Copenhagen, 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 Rheumatologym Glostrup Hospital; 🇩🇰 Copenhagen, Denmark

Dep. of Rheumatology, Køge Hospital; 🇩🇰 Køge, Denmark

Dep. of Rheumatology, Gentofte Hospital; 🇩🇰 Copenhagen, Denmark

Dep. of Rheumatology, Helsingør Hospital; 🇩🇰 Hørsholm, Denmark