Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients

NCT ID: NCT03440892

Last Updated: 2022-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2025-01-31

Brief Summary

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To validate the utility of survivin as a biomarker of pharmacological response to therapeutic intervention in rheumatoid arthritis patients.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

methotrexate

Intervention Type DRUG

folate antagonist

sulfasalazine

Intervention Type DRUG

Immunomodulatory

abatacept

Intervention Type DRUG

Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4)

tocilizumab

Intervention Type DRUG

IL-6 receptor antagonist

tofacitinib/baricitinib

Intervention Type DRUG

JAK inhibitor

Interventions

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methotrexate

folate antagonist

Intervention Type DRUG

sulfasalazine

Immunomodulatory

Intervention Type DRUG

abatacept

Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4)

Intervention Type DRUG

tocilizumab

IL-6 receptor antagonist

Intervention Type DRUG

tofacitinib/baricitinib

JAK inhibitor

Intervention Type DRUG

Other Intervention Names

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Salazopyrin Orencia RoActemra Xeljanz/Olumiant

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dept of Rheumatology and Inflammation research

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Maria Bokarewa, MD

Role: CONTACT

Facility Contacts

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Sofia T Silfverswärd

Role: primary

Other Identifiers

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Survivin in Treatment

Identifier Type: -

Identifier Source: org_study_id

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