The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
NCT ID: NCT01270087
Last Updated: 2011-01-05
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
PHASE4
14 participants
INTERVENTIONAL
2005-05-31
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Adalimumab
Adalimumab
40 mg IV every 14 days
Interventions
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Adalimumab
40 mg IV every 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid arthritis
* Active disease despite treatment with at least one disease modifying anti-rheumatic drug
* Treatment with adalimumab indicated according to the the patient's rheumatologist
* At least six swollen joints in 28-joint index
* CRP \> 8 mg / L within the last three months
Exclusion Criteria
* Treatment with intravenous corticosteroids within fourteen days
* Ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion
* Severe bleeding disorder
* Extensive or refractory leg ulcers
* Severe peripheral vascular disease
18 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
The Swedish Research Council
OTHER_GOV
The Swedish Rheumatism Ass
OTHER
Crafoord Foundation
OTHER
Skane University Hospital
OTHER
Responsible Party
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Department of Rheumatology, Skåne University Hospital
Principal Investigators
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Carl Turesson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Rheumatology, Skåne University Hospital
Locations
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Department of Rheumatology, Skåne University Hospital
Malmo, , Sweden
Countries
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Other Identifiers
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2005-000129-47
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REUMAUMAS 2005-1
Identifier Type: -
Identifier Source: org_study_id
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