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OpenTrials
Completed

NCT Number: NCT01270087

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Rheumatology, Skåne University Hospital

Malmö, 205 02, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adalimumab

Drug

40 mg IV every 14 days

Other names: Humira

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Abbott
  • Crafoord Foundation
  • The Swedish Research Council
  • The Swedish Rheumatism Ass

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jan 5, 2011
Registry last updated
Jan 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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