Bone Resorption, Osteoclastogenesis and Adalimumab (BROCA)

This study has been completed.
Information provided by (Responsible Party):
Artur de Brum-Fernandes, Université de Sherbrooke Identifier:
First received: December 23, 2008
Last updated: December 10, 2013
Last verified: December 2013
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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Bone Resorption, Osteoclastogenesis and Adalimumab

Resource links provided by NLM:

Further study details as provided by Université 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 ]

Enrollment: 28
Study Start Date: September 2008
Study Completion Date: March 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Adalimumab
    Adalimumab 40 mg sub-cutaneously every two weeks
    Other Name: Humira
  Show Detailed Description


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

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
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Please refer to this study by its identifier: NCT00814866

Canada, Quebec
Centre de Recherche Clinique Ethienne Lebel
Fleurimont, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
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: Artur de Brum-Fernandes, MD, Université de Sherbrooke Identifier: NCT00814866     History of Changes
Other Study ID Numbers: crcel08045  HUM 07-061 
Study First Received: December 23, 2008
Last Updated: December 10, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Bone Resorption
Autoimmune Diseases
Bone Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 25, 2016