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The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
This study has been completed.
Sponsor:
Skåne University Hospital
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
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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: | 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:
Genetics Home Reference related topics:
rheumatoid arthritis
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 ]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 ]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 ]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) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01270087
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 ( EudraCT Number ) |
| Study First Received: | January 4, 2011 |
| Last Updated: | January 4, 2011 |
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 June 23, 2017