Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis

NCT01417455 | Completed Results

• 1 other identifier: BCRAAS
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis; Bone Resorption; Ankylosing Spondylitis

Keywords

Rheumatoid arthritis; Ankylosing spondylitis; Osteoclasts; TNF antagonists

Outcome Measures

Primary Outcomes (2)

• Osteoclast Differentiation Ex-vivo

  Osteoclasts will be differentiated from untreated patients and patients under several TNF blockers.

  at baseline and at 6 months

• Osteoclast Activity Ex-vivo

  Total area resorbed by osteoclasts as percentage of total area analyzed

  at baseline and at 6 months

Study Arms (3)

Rheumatoid Arthritis

Active Rheumatoid Arthritis patients

Ankylosing Spondylitis

Active Ankylosing Spondylitis

Controls

Healthy donors age and sex matched to the patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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).

You may not qualify if:

• Inactive disease

Sponsors & Collaborators

• Instituto de Medicina Molecular João Lobo Antunes: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Instituto de Medicina Molecular

Lisbon, 1600-145, Portugal

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and bone samples

MeSH Terms

Conditions

Arthritis, Rheumatoid; Bone Resorption; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Ankylosis

Results Point of Contact

• Title: João Eurico Fonseca
• Organization: Instituto de Medicina Molecular

jecfonseca@gmail.com

+351217999544

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: January 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 21, 2016
• Results First Posted: March 21, 2016

Record last verified: 2016-02

Locations

PT (1)