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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02035800 |
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Date of registration:
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10/12/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Bone Resorption, Osteoclastogenesis and Adalimumab
BROCAII |
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Scientific title:
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Bone Resorption, Osteoclastogenesis and Adalimumab |
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Date of first enrolment:
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May 2013 |
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Target sample size:
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120 |
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Recruitment status: |
Unknown status |
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URL:
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https://clinicaltrials.gov/show/NCT02035800 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Artur Fernandes |
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Address:
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Telephone:
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819-346-1110 |
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Email:
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Artur.Jose.De.B.Fernandes@USherbrooke.ca |
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Affiliation:
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Name:
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Stéphanie Mcmahon |
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Address:
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Telephone:
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819-346-1110 |
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Email:
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Affiliation:
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Name:
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Artur Ferandnes |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre de recherche Étienne Le-Bel at Centre hospitalier universitaire de Sherbrooke |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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RheumatoId Arthritis
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Intervention(s)
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Drug: Adalimumab
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Primary Outcome(s)
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Verify if the treatment with Adalimumab may be associated with a reduction in the number of osteoclasts.
[Time Frame: 6 months after treatment]
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Secondary Outcome(s)
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Verify if this reduction may be associated with a better response to the treatment.
[Time Frame: 6 months after treatment]
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To verify reduction of osteoclasts may be associated with a better response to the treatment.
[Time Frame: 6 months after traitment]
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To verify reduction of osteoclasts may be associated with a better response to the treatment.
[Time Frame: 6 months after treatment]
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Secondary ID(s)
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IMM 11-0163
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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