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Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients (SurviTreat)

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ClinicalTrials.gov Identifier: NCT03440892
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Study Description
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Brief Summary:
To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: methotrexate Drug: sulfasalazine Drug: abatacept Drug: tocilizumab Drug: tofacitinib/baricitinib

Detailed Description:
In a prospective observational study the investigators aim to study the ability of modern antirheumatic treatments to suppress levels of survivin in sera. Rheumatoid arthritis patients scheduled to start new pharmacological treatment will be followed for a period of 6 months. No intervention or influence on choice of treatment will be performed, the decision of new/other medication is entirely made by the patient and their rheumatologist. The study entails addition of survivin analyse (1 vial of sera) before and after start of new treatment. Data concerning survivin levels, disease activity and other clinical parameters before and after start of new treatment will also be analysed. The patients will leave sera for survivin analyse at baseline and 3 and 6 months after start of new treatment.
Study Design
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Study Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1 Drug: methotrexate
folate antagonist

Drug: sulfasalazine
Immunomodulatory
Other Name: Salazopyrin

Drug: abatacept
Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4)
Other Name: Orencia

Drug: tocilizumab
IL-6 receptor antagonist
Other Name: RoActemra

Drug: tofacitinib/baricitinib
JAK inhibitor
Other Name: Xeljanz/Olumiant


Outcome Measures
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Primary Outcome Measures :
  1. Survivin status [ Time Frame: 6 months ]

    Patients with a survivin level of over 0.45 ng/ml are considered to be survivin positive.

    Patients with survivin levels under 0.45 ng/ml are considered to be survivin negative

    A change from survivin positive to survivin negative (or vice versa) equals conversion of survivin status.



Secondary Outcome Measures :
  1. Disease activity (DAS28) [ Time Frame: 6 months ]

    Disease activity, DAS28, is calculated using a specific formula based on:

    • number of painful joints from 28 joints
    • number of swollen joints from 28 joints
    • erythrocyte sedimentation rate (ESR) or C reactive protein (CRP)
    • patient's global assessment of disease activity on a 100 mm visual analogue scale (VAS)

    DAS thresholds:

    DAS28 below 3.2: low disease activity DAS28 over 3.2 and under 5.1: moderate disease activity DAS28 above 5.1: high disease activity DAS28 lower than 2.6: remission


  2. Response to treatment [ Time Frame: 6 months ]

    The EULAR response criteria classify patients as good, moderate, or non-responders, using the change in DAS28 and the level of DAS28 reached. A patient must show a significant change as well as low disease activity to be classified as a good responder.

    Good responder: DAS28 scores ≤ 3.2 with reductions in DAS28 >1.2 Moderate responder: DAS28 scores > 3.2 with reductions in DAS28 >1.2 Non-responder: reductions in DAS28 ≤ 0.6



Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid arthritis patients
Criteria

Inclusion Criteria:

  • Patients fulfilling the RA classification criteria according to the ACR/EULAR

Exclusion Criteria:

  • Patients at stable/unchanged anti-rheumatic treatment
  • Other serious physical or mental illness
  • Lack of knowledge in Swedish making answering the questionnaires impossible
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440892


Contacts
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Contact: Maria Bokarewa, MD maria.bokarewa@rheuma.gu.se

Locations
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Sweden
Dept of Rheumatology and Inflammation research Recruiting
Gothenburg, Sweden
Contact: Sofia T Silfverswärd       sofia.silfversward@rheuma.gu.se   
Sponsors and Collaborators
Vastra Gotaland Region
More Information
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Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT03440892    
Other Study ID Numbers: Survivin in Treatment
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vastra Gotaland Region:
survivin
biomarker of pharmacological response
antirheumatic treatment
methotrexate
 sulfasalazin
abatacept
tocilizumab
tofacitinib/baricitinib
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Sulfasalazine
Methotrexate
Abatacept
Tofacitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Immune Checkpoint Inhibitors
Protein Kinase Inhibitors
Anti-Infective Agents