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Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis

This study is not yet open for participant recruitment.
Verified December 2011 by Instituto de Medicina Molecular
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
João Eurico Cortez Cabral da Fonseca, Instituto de Medicina Molecular
ClinicalTrials.gov Identifier:
NCT01417455
First received: August 15, 2011
Last updated: December 13, 2011
Last verified: December 2011
History of Changes
  Purpose

Rheumatoid arthritis (RA) and ankylosing spondylitis (AS) are characterized by chronic systemic inflammation and share common pathogenic pathways. In both diseases, cytokines like TNF and IL-17, known for their pro-inflammatory and osteoclastogenic effects, are relevant players, however, while RA is characterized by bone erosions, AS favors bone overgrowth. Understanding this paradox may hold the key for a better management of both diseases. Our hypothesis is that there are differences in the cellular environment and intracellular signaling between AS and RA. To test this hypothesis we will evaluate the cytokine milieu, the kinetics of bone cells differentiation and their activity in untreated and immunosuppressed RA and AS patients. We will also perform the same observations in patients exposed to targeted treatments.


Condition
Cytokine Environment
Kinetics of Bone Cells Differentiation and Activity in Untreated RA and AS Patients.

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Medicina Molecular:

Biospecimen Retention:   Samples With DNA

Blood and bone samples


Estimated Enrollment: 125
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid Arthritis
Active Rheumatoid Arthritis patients
Ankylosing Spondylitis
Active Ankylosing Spondylitis

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with RA diagnosis (according to the revised American Rheumatism Association criteria, 1988) and AS diagnosis (according to the European Spondyloarthropathy Study Group criteria, 1991)

Criteria

Inclusion Criteria:

  • Patients with RA diagnosis (according to the revised American Rheumatism Association criteria, 1988) and AS diagnosis (according to the European Spondyloarthropathy Study Group criteria, 1991) followed up in the Rheumatology and Bone and Metabolic Diseases Department of Hospital de Santa Maria (HSM) will be recruited for this study. Patients have to have active RA (Disease Activity Score 28 (DAS28)>3.2) or active AS (Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)>4).

Exclusion Criteria:

  • Inactive disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417455

Contacts
Contact: João Fonseca, MD, PhD 00351969049532 jefonseca@netcabo.pt

Locations
Portugal
Instituto de Medicina Molecular Not yet recruiting
Lisbon, Portugal, 1600-145
Contact: João Fonseca, MD, PhD     00351969049532     jefonseca@netcabo.pt    
Principal Investigator: João Fonseca, MD, PhD            
Sponsors and Collaborators
Instituto de Medicina Molecular
Merck
  More Information

No publications provided

Responsible Party: João Eurico Cortez Cabral da Fonseca, MD PhD, Instituto de Medicina Molecular
ClinicalTrials.gov Identifier: NCT01417455     History of Changes
Other Study ID Numbers: BCRAAS
Study First Received: August 15, 2011
Last Updated: December 13, 2011
Health Authority: Portugal: National Pharmacy and Medicines Institute

Keywords provided by Instituto de Medicina Molecular:
Rheumatoid arthritis, ankylosing spondylitis, Osteoclasts, Osteoblasts, TNF antagonists

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis

ClinicalTrials.gov processed this record on May 21, 2013