Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Joao Eurico Cortez Cabral da Fonseca, Instituto de Medicina Molecular
ClinicalTrials.gov Identifier:
NCT01417455
First received: August 15, 2011
Last updated: February 29, 2016
Last verified: February 2016
  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 (tumor necrosis factor) and interleukin (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
Rheumatoid Arthritis
Bone Resorption
Ankylosing Spondylitis

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:


Further study details as provided by Instituto de Medicina Molecular:

Primary Outcome Measures:
  • Osteoclast Differentiation Ex-vivo [ Time Frame: at baseline and at 6 months ] [ Designated as safety issue: No ]
    Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.

  • Osteoclast Activity Ex-vivo [ Time Frame: at baseline and at 6 months ] [ Designated as safety issue: No ]
    Total area resorbed by osteoclasts as percentage of total area analyzed


Biospecimen Retention:   Samples With DNA
Blood and bone samples

Enrollment: 101
Study Start Date: January 2012
Study Completion Date: May 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid Arthritis
Active Rheumatoid Arthritis patients
Ankylosing Spondylitis
Active Ankylosing Spondylitis
Controls
Healthy donors age and sex matched to the patients

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01417455

Locations
Portugal
Instituto de Medicina Molecular
Lisbon, Portugal, 1600-145
Sponsors and Collaborators
Instituto de Medicina Molecular
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Joao 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
Results First Received: January 3, 2016
Last Updated: February 29, 2016
Health Authority: Portugal: National Pharmacy and Medicines Institute
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Instituto de Medicina Molecular:
Rheumatoid arthritis
Ankylosing spondylitis
Osteoclasts
TNF antagonists

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Bone Resorption
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 August 24, 2016