The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Skane University Hospital
• Collaborators: Abbott; Crafoord Foundation; The Swedish Research Council; The Swedish Rheumatism Ass
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Clinical diagnosis of rheumatoid arthritis

• 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 anti-TNF drugs in the last three months

• 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