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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02035800
Date of registration: 10/12/2013
Prospective Registration: No
Primary sponsor: Université de Sherbrooke
Public title: Bone Resorption, Osteoclastogenesis and Adalimumab BROCAII
Scientific title: Bone Resorption, Osteoclastogenesis and Adalimumab
Date of first enrolment: May 2013
Target sample size: 120
Recruitment status: Unknown status
URL:  https://clinicaltrials.gov/show/NCT02035800
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Canada
Contacts
Name:     Stéphanie Mcmahon
Address: 
Telephone: 819-346-1110
Email:
Affiliation: 
Name:     Artur Ferandnes
Address: 
Telephone:
Email:
Affiliation:  Centre de recherche Étienne Le-Bel at Centre hospitalier universitaire de Sherbrooke
Name:     Artur Fernandes
Address: 
Telephone: 819-346-1110
Email: Artur.Jose.De.B.Fernandes@USherbrooke.ca
Affiliation: 
Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients aged of 18 and over,

- Satisfying the 1987 American College of Rheumatology (ACR) criteria for RA

- Receiving a prescription of Adalimumab 40 mg subcutaneous every two weeks.

Exclusion Criteria:

- Patients not capable or willing to provide informed consent

- Patients starting Adalimumab less than five half-lives after the interruption of a
previous anti-TNF therapy.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
RheumatoId Arthritis
Intervention(s)
Drug: Adalimumab
Primary Outcome(s)
Verify if the treatment with Adalimumab may be associated with a reduction in the number of osteoclasts. [Time Frame: 6 months after treatment]
Secondary Outcome(s)
To verify reduction of osteoclasts may be associated with a better response to the treatment. [Time Frame: 6 months after treatment]
To verify reduction of osteoclasts may be associated with a better response to the treatment. [Time Frame: 6 months after traitment]
Verify if this reduction may be associated with a better response to the treatment. [Time Frame: 6 months after treatment]
Secondary ID(s)
IMM 11-0163
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
AbbVie
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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