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

Skane University Hospital

Status and phase

Completed

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Adalimumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01270087

2005-000129-47 (EudraCT Number)

REUMAUMAS 2005-1

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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