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

NCT ID: NCT01270087

Last Updated: 2011-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adalimumab

Group Type OTHER

Adalimumab

Intervention Type DRUG

40 mg IV every 14 days

Interventions

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Adalimumab

40 mg IV every 14 days

Intervention Type DRUG

Other Intervention Names

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Humira

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

The Swedish Rheumatism Ass

OTHER

Sponsor Role collaborator

Crafoord Foundation

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Rheumatology, Skåne University Hospital

Principal Investigators

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Carl Turesson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Rheumatology, Skåne University Hospital

Locations

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Department of Rheumatology, Skåne University Hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2005-000129-47

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

REUMAUMAS 2005-1

Identifier Type: -

Identifier Source: org_study_id

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