Clinical trial NCT01029613: Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2009-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis according to the ACR criteria (1987) with high disease activity starting TNF-alpha inhibitor

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.


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

Primary outcomes:
measure: EULAR response criteria
timeFrame: 16 weeks
Secondary outcomes:
measure: Number of joints with inflammation on MRI
timeFrame: 16 and 52 weeks
measure: Erosions on X-rays and CT
timeFrame: 52 weeks
measure: Biomarkers
timeFrame: 16 and 52 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dep. of medicine, Herlev Hospital
city: Copenhagen
country: Denmark
facility: Dep. of Radiology, Herlev Hospital
city: Copenhagen
country: Denmark
facility: Dep. of Rheumatology, Frederiksberg and Bispebjerg Hospitals
city: Copenhagen
country: Denmark
facility: Dep. of Rheumatology, Gentofte Hospital
city: Copenhagen
country: Denmark
facility: Dep. of Rheumatology, Glostrup Hospital
city: Copenhagen
country: Denmark
facility: Dep. of Rheumatologym Glostrup Hospital
city: Hørsholm
country: Denmark
facility: Dep. of Rheumatology, Helsingør Hospital
city: Køge
country: Denmark
facility: Dep. of Rheumatology, Køge Hospital
Study officials:
affiliation: Dep. of Rheumatology, Glostrup Hospital
name: Mikkel Østergaard, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Rheumatology, Glostrup Hospital
name: Susanne J Pedersen, MD
role: STUDY_CHAIR
References: