Trial | NCT01270087  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    adalimumab ...

  • Study Participants

    14
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.
Study Started
May 31
2005
Primary Completion
Feb 28
2007
Study Completion
Feb 28
2007
Last Update
Jan 05
2011
Estimate

Drug Adalimumab

40 mg IV every 14 days

  • Other names: Humira

Adalimumab Other

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
No Results Posted