Bone Resorption, Osteoclastogenesis and Adalimumab - Full Text View

Sponsored by:	Universitaire de Sherbrooke
Information provided by:	Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:	NCT00814866

Purpose

Osteoclastic bone resorption depends on both the capacity to generate osteoclasts (osteoclastogenesis) and on individual osteoclast activity. The investigators objective is to study the effect of anti-TNF therapy on the number of osteoclast precursors in the peripheral blood of patients with Rheumatoid Arthritis, on in vitro osteoclastogenesis and on osteoclast activity before and during the treatment of patients with Rheumatoid Arthritis with Adalimumab.

Condition	Intervention
Rheumatoid Arthritis	Drug: Adalimumab

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Historical Control, Single Group Assignment
Official Title:	Bone Resorption, Osteoclastogenesis and Adalimumab

Further study details as provided by Universitaire de Sherbrooke:

Primary Outcome Measures:

The number of osteoclast precursor (CD14+) cells in the peripheral blood [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
The number of osteoclasts genereated in vitro [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
The amount of bone resorption in vitro [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Osteoclast differentiation in the presence of exogenous Adalimumab [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
Disease activity defined by the DAS28 score [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]
Change in functionnal status measured by the M-HAQ [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	September 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Adalimumab 40 mg sub-cutaneously every two weeks

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients satisfying the ACR criteria for Rheumatoid arthritis and having received a prescription of Adalimumab at the Centre Hospitalier Universitaire de Sherbrooke.

Exclusion Criteria:

Patients under 18 years old
Patients unwilling or unable to sign an informed consent
Patients starting Adalimumab less than five half-lifes after the interruption of a previous anbti-TNF therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814866

Contacts

Contact: Artur Fernandes, MD. PhD	819-564-5261	Artur.Fernandes@USherbrooke.ca
Contact: Gilles Boire, MD. M.Sc.	819-564-5261	Gilles.Boire@USherbrooke.ca

Locations

Canada, Quebec
Centre de Recherche Clinique Ethienne Lebel	Recruiting
Fleurimont, Quebec, Canada, J1H 5N4
Contact: Artur Fernandes, MD,PhD 819-564-5261 Artur.Fernandes@USherbrooke.ca
Contact: Gilles Boire, MD, M.Sc. 819-564-5261 Gilles.Boire@USherbrooke.ca
Principal Investigator: Artur Fernandes, MD, PhD
Principal Investigator: Gilles Boire, MD, M.Sc.
Sub-Investigator: Patrick Liang, MD
Sub-Investigator: Ariel Masetto, MD

Sponsors and Collaborators

Universitaire de Sherbrooke

Investigators

Principal Investigator:	Artur Fernandes, MD, PhD	Centre Hospitalier Universitaire de Sherbrooke
Principal Investigator:	Gilles Boire, MD, M.Sc.	Centre Hospitalier Universitaire de Sherbrooke

More Information

Responsible Party:	Universitaire de Sherbrooke ( Artur Fernandes )
Study ID Numbers:	crcel08045, HUM 07-061
Study First Received:	December 23, 2008
Last Updated:	December 23, 2008
ClinicalTrials.gov Identifier:	NCT00814866
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Universitaire de Sherbrooke:

Rheumatoid arthritis
arthritis
osteoclasts
bone

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Bone Resorption
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Adalimumab
Bone Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009