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NCT03444623 Clinical Trial

Survivin as Predictive Biomarker for RA

Rheumatoid Arthritis Clinical Trial

— SurviPred  

Official title:
Survivin as Predictive Biomarker for Development of Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03444623
Other study ID # Survivin rutin
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 2013
Est. completion date December 2023

Study information
Verified date May 2022
Source Vastra Gotaland Region
Contact Maria Bokarewa, MD
Email maria.bokarewa@rheuma.gu.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Purpose: to examine the possibility of using the onco-protein survivin as a predictive biomarker for identifying individuals at risk of developing rheumatoid arthritis within a cohort of patients seeking treatment for joint pain/stiffness. Secondly, to study survivin as a prognostic marker for joint destruction, refractory and highly active disease in patients with established RA.

Description:

The study will analyse survivin levels in a non-selected material within a cohort of patients seeking help at their primary health care for joint pain, stiffness, swelling etc. Patients presenting with such symptoms (not explained by injury or other factors) are suspected to have an arthritic condition such as RA, and are routinely tested for presence of autoantibodies RF and ACPA. In this observational study we add measurement for survivin to the blood analyses of these patients. Information about patients expressing high levels of survivin will be reported to the referring doctor at the primary health care, and for patients not previously having been examined by a rheumatologist this will be offered. The study will be performed at Sahlgrenska university hospital Gothenburg and Umeå university hospital.

Recruitment information / eligibility
Status Recruiting
Enrollment 6000
Est. completion date December 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness). Exclusion Criteria: - Patients diagnosed with RA

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Sweden Dept of Rheumatology and Inflammation research Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survivin positive Survivin positive: > 0,45 ng/ml Survivin negative: < 0,45 ng/ml 1 year
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