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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270087
• Other study ID #: REUMAUMAS 2005-1
• Secondary ID: 2005-000129-47
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2011
• Last updated: January 4, 2011
• Start date: May 2005
• Est. completion date: February 2007

Study information

• Verified date: January 2007
• Source: Skåne University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Adalimumab
40 mg IV every 14 days

Locations

Country	Name	City	State
Sweden	Department of Rheumatology, Skåne University Hospital	Malmö

Sponsors (5)

Lead Sponsor	Collaborator
Skåne University Hospital	Abbott, Crafoord Foundation, The Swedish Research Council, The Swedish Rheumatism Ass

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial expression of HLA-DQ in muscle biopsies	Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis	3 months	No
Primary	Endothelial expression of interleukin-1 alpha in muscle biopsies	Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis	3 months	No
Primary	Carotid artery intima-media thickness	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.	3 months	No