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

NCT01270087 | Completed Phase 4 DMC

• 2 other identifiers: REUMAUMAS 2005-12005-000129-47
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, cardiovascular disease, adalimumab

Outcome Measures

Primary Outcomes (3)

• Endothelial expression of HLA-DQ in muscle biopsies

  Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis

  3 months

• 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

  3 months

• 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.

  3 months

Study Arms (1)

Adalimumab

OTHER

Drug: Adalimumab

Interventions

Adalimumab DRUG

40 mg IV every 14 days

Also known as: Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Treatment with anti-TNF drugs in the last three months
• Treatment with intravenous corticosteroids within fourteen days
• Severe bleeding disorder
• Extensive or refractory leg ulcers
• Severe peripheral vascular disease

Sponsors & Collaborators

• Skane University Hospital: lead
• Abbott: collaborator
• The Swedish Research Council: collaborator
• The Swedish Rheumatism Ass: collaborator
• Crafoord Foundation: collaborator

Study Sites (1)

Department of Rheumatology, Skåne University Hospital

Malmo, 205 02, Sweden

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Cardiovascular Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Carl Turesson, MD, PhD

  Department of Rheumatology, Skåne University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2011
• First Posted: January 5, 2011
• Study Start: May 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: January 5, 2011

Record last verified: 2007-01

Locations

SE (1)