The Effect of Adalimumab (Humira) on Vascular Abnormaliti... | NCT01270087

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

NCT01270087

Sponsor

Skane University Hospital

Status

Completed

Last Update Posted

Jan 5, 2011Estimated

Enrollment

14Actual

Phase

Phase 4

Conditions

Rheumatoid Arthritis

Interventions

Adalimumab

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2005-000129-47	EudraCT Number

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Feb 2007Actual

Completion Date

Feb 2007Actual

First Submitted Date

Jan 4, 2011

First Submission Date that Met QC Criteria

Jan 4, 2011

First Posted Date

Jan 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2011

Last Update Posted Date

Jan 5, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Skane University HospitalOTHER

Collaborators

Name	Class
Abbott	INDUSTRY
The Swedish Research Council	OTHER_GOV
The Swedish Rheumatism Ass	OTHER
Crafoord Foundation

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Label	Type	Description	Intervention Names
Adalimumab	Other		Drug: Adalimumab

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab	Drug	40 mg IV every 14 days	Adalimumab	Humira

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carl Turesson, MD, PhD	Department of Rheumatology, Skåne University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Rheumatology, Skåne University Hospital		Malmö		205 02	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068879	Adalimumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided