Bone Resorption, Osteoclastogenesis and Adalimumab

NCT02035800 | Unknown Phase 4 DMC

• 1 other identifier: IMM 11-0163
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Rheumatoid Arthritis; Adalimumab; Humira

Outcome Measures

Primary Outcomes (1)

• Verify if the treatment with Adalimumab may be associated with a reduction in the number of osteoclasts.

  By calculating the number of osteoclast and osteoblast in patient serum.

  6 months after treatment

Secondary Outcomes (3)

• Verify if this reduction may be associated with a better response to the treatment.

  6 months after treatment

• To verify reduction of osteoclasts may be associated with a better response to the treatment.

  6 months after treatment

• To verify reduction of osteoclasts may be associated with a better response to the treatment.

  6 months after traitment

Study Arms (1)

Adalimumab (humira)

EXPERIMENTAL

As standard of care.

Drug: Adalimumab

Interventions

Adalimumab DRUG

Patient will received medication as standard of care

Also known as: Humira

Adalimumab (humira)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• AbbVie: collaborator

Study Sites (1)

CRC Étienne Le-Bel at CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Artur Ferandnes

  Centre de recherche Étienne Le-Bel at Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Artur Fernandes

CONTACT

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

Gilles Boire

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: January 14, 2014
• Study Start: May 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

CA (1)