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

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ClinicalTrials.gov Identifier: NCT01270087
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : January 5, 2011
Sponsor:
Collaborators:
Abbott
The Swedish Research Council
The Swedish Rheumatism Ass
Crafoord Foundation
Information provided by:
Skane University Hospital

Study Description
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arms and Interventions
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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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270087


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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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    Key Record Dates
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