Clincosm LogoSign in Get a demo

SurviPred: Survivin as Predictive Biomarker for RA

Sponsor
Vastra Gotaland Region (Other)
Overall Status
Recruiting
CT.gov ID
NCT03444623
Collaborator
(none)
6,000
Enrollment
1
Location
126
Anticipated Duration (Months)
47.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Survivin as Predictive Biomarker for Development of Rheumatoid Arthritis
    Actual Study Start Date :
    Jun 1, 2013
    Anticipated Primary Completion Date :
    Jun 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Survivin positive [1 year]

      Survivin positive: > 0,45 ng/ml Survivin negative: < 0,45 ng/ml

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients seeking treatment at the primary health care for problems with their joints (pain, stiffness).
    Exclusion Criteria:
    • Patients diagnosed with RA

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept of Rheumatology and Inflammation research Gothenburg Sweden

    Sponsors and Collaborators

    • Vastra Gotaland Region

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vastra Gotaland Region
    ClinicalTrials.gov Identifier:
    NCT03444623
    Other Study ID Numbers:
    • Survivin rutin
    First Posted:
    Feb 23, 2018
    Last Update Posted:
    May 4, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Vastra Gotaland Region
    predictive factor
    prognostic factor
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Arthralgia

    Study Results

    No Results Posted as of May 4, 2022