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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis	Drug: Adalimumab	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	14 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
Study Start Date :	May 2005
Actual Primary Completion Date :	February 2007
Actual Study Completion Date :	February 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Adalimumab	Drug: Adalimumab; 40 mg IV every 14 days; Other Name: Humira

Outcome Measures

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Primary Outcome Measures :

1. Endothelial expression of HLA-DQ in muscle biopsies [ Time Frame: 3 months ]
   Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis
2. Endothelial expression of interleukin-1 alpha in muscle biopsies [ Time Frame: 3 months ]
   Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis
3. Carotid artery intima-media thickness [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Sweden
Department of Rheumatology, Skåne University Hospital
Malmö, Sweden, 205 02

Sponsors and Collaborators

Skane University Hospital

Abbott

The Swedish Research Council

The Swedish Rheumatism Ass

Crafoord Foundation

Investigators

Principal Investigator:	Carl Turesson, MD, PhD	Department of Rheumatology, Skåne University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Carl Turesson, Associate Professor, Department of Rheumatology, Skåne University Hospital
ClinicalTrials.gov Identifier:	NCT01270087 History of Changes
Other Study ID Numbers:	REUMAUMAS 2005-1; 2005-000129-47 ( EudraCT Number )
First Posted:	January 5, 2011
Last Update Posted:	January 5, 2011
Last Verified:	January 2007

Keywords provided by Skane University Hospital:

Rheumatoid arthritis, cardiovascular disease, adalimumab

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases	Autoimmune Diseases; Immune System Diseases; Adalimumab; Anti-Inflammatory Agents; Antirheumatic Agents