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Bone Resorption, Osteoclastogenesis and Adalimumab (BROCA)

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ClinicalTrials.gov Identifier: NCT00814866
Recruitment Status : Completed
First Posted : December 25, 2008
Last Update Posted : October 27, 2016
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Artur de Brum-Fernandes, Université de Sherbrooke

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Adalimumab Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bone Resorption, Osteoclastogenesis and Adalimumab
Study Start Date : September 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Adalimumab
U.S. FDA Resources

Arm Intervention/treatment
Adalimumab
Open label
Drug: Adalimumab
Adalimumab 40 mg sub-cutaneously every two weeks
Other Name: Humira



Primary Outcome Measures :
  1. The number of osteoclast precursor (CD14+) cells in the peripheral blood [ Time Frame: 0, 3 and 6 months ]
  2. The number of osteoclasts genereated in vitro [ Time Frame: 0, 3 and 6 months ]
  3. The amount of bone resorption in vitro [ Time Frame: 0, 3 and 6 months ]

Secondary Outcome Measures :
  1. Osteoclast differentiation in the presence of exogenous Adalimumab [ Time Frame: 0, 3 and 6 months ]
  2. Disease activity defined by the DAS28 score [ Time Frame: 0, 3 and 6 months ]
  3. Change in functionnal status measured by the M-HAQ [ Time Frame: 0, 3 and 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814866


Locations
Canada, Quebec
Centre de Recherche Clinique Ethienne Lebel
Fleurimont, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
Abbott
Investigators
Principal Investigator: Artur Fernandes, MD, PhD Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Principal Investigator: Gilles Boire, MD, M.Sc. Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Responsible Party: Artur de Brum-Fernandes, MD, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT00814866     History of Changes
Other Study ID Numbers: crcel08045
HUM 07-061
First Posted: December 25, 2008    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: December 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Artur de Brum-Fernandes, Université de Sherbrooke:
Rheumatoid arthritis
arthritis
osteoclasts
bone

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Bone Resorption
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents