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Trial record 60 of 62 for:    Baricitinib

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03440892
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : March 6, 2019
Information provided by (Responsible Party):
Vastra Gotaland Region

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.

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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 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
1 Drug: methotrexate
folate antagonist

Drug: sulfasalazine
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

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

Information from the National Library of Medicine

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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

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

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 identifier (NCT number): NCT03440892

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Contact: Maria Bokarewa, MD

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Dept of Rheumatology and Inflammation research Recruiting
Gothenburg, Sweden
Contact: Sofia T Silfverswärd   
Sponsors and Collaborators
Vastra Gotaland Region

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Responsible Party: Vastra Gotaland Region Identifier: NCT03440892     History of Changes
Other Study ID Numbers: Survivin in Treatment
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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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:
biomarker of pharmacological response
antirheumatic treatment
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal