The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
Information source: Skåne University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Adalimumab (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Skåne University Hospital Official(s) and/or principal investigator(s): Carl Turesson, MD, PhD, Principal Investigator, Affiliation: Department of Rheumatology, SkÃ¥ne University Hospital
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.
Clinical Details
Official title: The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Endothelial expression of HLA-DQ in muscle biopsiesEndothelial expression of interleukin-1 alpha in muscle biopsies Carotid artery intima-media thickness
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Department of Rheumatology, Skåne University Hospital, Malmö 205 02, Sweden
Additional Information
Starting date: May 2005
Last updated: January 4, 2011
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