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The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.

Information source: Skne 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: Skne University Hospital

Official(s) and/or principal investigator(s):
Carl Turesson, MD, PhD, Principal Investigator, Affiliation: Department of Rheumatology, Skåne University Hospital


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 biopsies

Endothelial expression of interleukin-1 alpha in muscle biopsies

Carotid artery intima-media thickness


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Clinical diagnosis of rheumatoid arthritis

- Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid


- Active disease despite treatment with at least one disease modifying anti-rheumatic


- 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

Page last updated: August 23, 2015

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