NCT00814866

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

October 27, 2016

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

December 23, 2008

Last Update Submit

October 26, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisarthritisosteoclastsbone

Outcome Measures

Primary Outcomes (3)

  • The number of osteoclast precursor (CD14+) cells in the peripheral blood

    0, 3 and 6 months

  • The number of osteoclasts genereated in vitro

    0, 3 and 6 months

  • The amount of bone resorption in vitro

    0, 3 and 6 months

Secondary Outcomes (3)

  • Osteoclast differentiation in the presence of exogenous Adalimumab

    0, 3 and 6 months

  • Disease activity defined by the DAS28 score

    0, 3 and 6 months

  • Change in functionnal status measured by the M-HAQ

    0, 3 and 6 months

Study Arms (1)

Adalimumab

OTHER

Open label

Drug: Adalimumab

Interventions

AdalimumabDRUG

Adalimumab 40 mg sub-cutaneously every two weeks

Also known as: Humira
Adalimumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients satisfying the ACR criteria for Rheumatoid arthritis and having received a prescription of Adalimumab at the Centre Hospitalier Universitaire de Sherbrooke.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherche Clinique Ethienne Lebel

Fleurimont, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Artur Fernandes, MD, PhD

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

  • Gilles Boire, MD, M.Sc.

    Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 23, 2008

First Posted

December 25, 2008

Study Start

September 1, 2008

Primary Completion

September 1, 2010

Study Completion

March 1, 2011

Last Updated

October 27, 2016

Record last verified: 2013-12

Locations

CA(1)