Back to resultsThe Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid arthritis, cardiovascular disease, adalimumab
Eligibility 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
Sites / Locations
- Department of Rheumatology, Skåne University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adalimumab
Arm Description
Outcomes
Primary Outcome Measures
Endothelial expression of HLA-DQ in muscle biopsies
Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis
Endothelial expression of interleukin-1 alpha in muscle biopsies
Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis
Carotid artery intima-media thickness
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01270087
First Posted
January 4, 2011
Last Updated
January 4, 2011
Sponsor
Skane University Hospital
Collaborators
Abbott, The Swedish Research Council, The Swedish Rheumatism Ass, Crafoord Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01270087
Brief Title
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
Official Title
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Skane University Hospital
Collaborators
Abbott, The Swedish Research Council, The Swedish Rheumatism Ass, Crafoord Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid arthritis, cardiovascular disease, adalimumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
40 mg IV every 14 days
Primary Outcome Measure Information:
Title
Endothelial expression of HLA-DQ in muscle biopsies
Description
Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis
Time Frame
3 months
Title
Endothelial expression of interleukin-1 alpha in muscle biopsies
Description
Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis
Time Frame
3 months
Title
Carotid artery intima-media thickness
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Turesson, MD, PhD
Organizational Affiliation
Department of Rheumatology, Skåne University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rheumatology, Skåne University Hospital
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
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