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

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Adalimumab

• Registration Number: NCT01270087
• Lead Sponsor: Skane University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Status Verified: 2007-01
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2011-01-04
• Study First Submitted QC: 2011-01-04
• Last Update Submitted: 2011-01-04
• Study First Posted: 2011-01-05
• Last Update Posted: 2011-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adalimumab	Adalimumab	-

Primary Outcome Measures

Name	Time	Method
Endothelial expression of HLA-DQ in muscle biopsies	3 months	Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis
Endothelial expression of interleukin-1 alpha in muscle biopsies	3 months	Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis
Carotid artery intima-media thickness	3 months	Thickness of the intima and media of the common carotid artery, measured by ultrasound. Mean of two measures of the right and left common carotid artery.

Trial Locations

Locations (1)

Department of Rheumatology, Skåne University Hospital; 🇸🇪 Malmö, Sweden