The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
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ClinicalTrials.gov Identifier: NCT01270087 |
Recruitment Status
:
Completed
First Posted
: January 5, 2011
Last Update Posted
: January 5, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Drug: Adalimumab | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study. |
Study Start Date : | May 2005 |
Actual Primary Completion Date : | February 2007 |
Actual Study Completion Date : | February 2007 |

Arm | Intervention/treatment |
---|---|
Adalimumab |
Drug: Adalimumab
40 mg IV every 14 days
Other Name: Humira
|
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270087
Sweden | |
Department of Rheumatology, Skåne University Hospital | |
Malmö, Sweden, 205 02 |
Principal Investigator: | Carl Turesson, MD, PhD | Department of Rheumatology, Skåne University Hospital |
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 ) |
First Posted: | January 5, 2011 Key Record Dates |
Last Update Posted: | January 5, 2011 |
Last Verified: | January 2007 |
Keywords provided by Skane 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 |