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

This study has been completed.
Sponsor:
Collaborators:
Abbott
The Swedish Research Council
The Swedish Rheumatism Ass
Crafoord Foundation
Information provided by:
Skåne University Hospital
ClinicalTrials.gov Identifier:
NCT01270087
First received: January 4, 2011
Last updated: NA
Last verified: January 2007
History: No changes posted

January 4, 2011
January 4, 2011
May 2005
February 2007   (final data collection date for primary outcome measure)
  • Endothelial expression of HLA-DQ in muscle biopsies [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis
  • Endothelial expression of interleukin-1 alpha in muscle biopsies [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis
  • Carotid artery intima-media thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.

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.
Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Adalimumab
40 mg IV every 14 days
Other Name: Humira
Adalimumab
Intervention: Drug: Adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
February 2007
February 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01270087
REUMAUMAS 2005-1, 2005-000129-47
Yes
Carl Turesson, Associate Professor, Department of Rheumatology, Skåne University Hospital
Skåne University Hospital
  • Abbott
  • The Swedish Research Council
  • The Swedish Rheumatism Ass
  • Crafoord Foundation
Principal Investigator: Carl Turesson, MD, PhD Department of Rheumatology, Skåne University Hospital
Skåne University Hospital
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP