Recruiting

Adalimumab

Sponsor:

Université de Sherbrooke

Code:

NCT02035800

Conditions

RheumatoId Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adalimumab

Study Details

Brief summary:

Broca II is the prolongation of the original study name BROCA. In BROCA study, only 25 patients participated and it was not enough to concluded clearly our hypothesis.

Conditions

RheumatoId Arthritis

Study ID

NCT02035800

Start date

May, 2013

Status verified date

May, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Adalimumab (humira)

As standard of care.

Interventions

Adalimumab

Patient will received medication as standard of care

Primary outcome measure

  • Verify if the treatment with Adalimumab may be associated with a reduction in the number of osteoclasts. [ Time Frame: 6 months after treatment ]

Central Contacts and Locations

Central contacts

Artur Fernandes

819-346-1110Artur.Jose.De.B.Fernandes@USherbrooke.ca

Gilles Boire

819-346-1110Gilles.Boire@usherbrooke.ca

Locations

CRC Étienne Le-Bel at CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

Stéphanie Mcmahon

819-346-1110

Maryse Berthiaume

819-346-1110

Principal Investigator:

Artur Fernandes

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 8, 2018

Last verified

May, 2018

Keywords

  • Rheumatoid Arthritis
  • Adalimumab
  • Humira

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2018-05-08.