N/A
Completed N=147
Differences in Bone Cell Activity Between Rheumatoid Arthritis and Ankylosing Spondylitis
Rheumatoid Arthritis · Bone Resorption · Ankylosing Spondylitis
Source: ClinicalTrials.gov NCT01417455 ↗
Enrolled (actual)
147
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Osteoclast Differentiation Ex-vivo — 8; 12; 11; 5 OC/mm2
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Osteoclast Differentiation Ex-vivo |
8; 12; 11; 5; 9; 3 | — |
| PRIMARY Osteoclast Activity Ex-vivo |
39; 11; 4; 0.6; 16; 2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01417455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.