Adalimumab in Rheumatoid Arthritis. An Investigation of Wholebody MRI, Conventional MRI, CT and Circulating Biomarkers
NCT ID: NCT01029613
Last Updated: 2015-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2009-12-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Rheumatoid arthritis
Adalimumab
sc. inj. Humira 40 mg every other week from week 0 to 52
Interventions
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Adalimumab
sc. inj. Humira 40 mg every other week from week 0 to 52
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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MOstergaard
Professor
Principal Investigators
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Mikkel Østergaard, Professor
Role: PRINCIPAL_INVESTIGATOR
Dep. of Rheumatology, Glostrup Hospital
Susanne J Pedersen, MD
Role: STUDY_CHAIR
Dep. of Rheumatology, Glostrup Hospital
Locations
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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 Rheumatology, Gentofte Hospital
Copenhagen, , Denmark
Dep. of Rheumatology, Glostrup Hospital
Copenhagen, , Denmark
Dep. of Rheumatologym Glostrup Hospital
Copenhagen, , Denmark
Dep. of Rheumatology, Helsingør Hospital
Hørsholm, , Denmark
Dep. of Rheumatology, Køge Hospital
Køge, , Denmark
Countries
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Other Identifiers
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WRAP
Identifier Type: -
Identifier Source: org_study_id
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