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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
  Purpose
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 Intervention Phase
Rheumatoid Arthritis
 Drug: Adalimumab
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Skåne University Hospital:

Primary Outcome Measures:
  • 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.
Enrollment: 14
Study Start Date: May 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Adalimumab Drug: Adalimumab
40 mg IV every 14 days
Other Name: Humira

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01270087

Locations
Sweden
Department of Rheumatology, Skåne University Hospital
Malmö, Sweden, 205 02
Sponsors and Collaborators
Skåne 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

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 
Study First Received: January 4, 2011
Last Updated: January 4, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by Skåne 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

ClinicalTrials.gov processed this record on September 29, 2016