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

May 3, 2022 updated by: Vastra Gotaland Region

Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rheumatoid arthritis patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Drug: methotrexate
folate antagonist
Drug: sulfasalazine
Immunomodulatory
Other Names:
  • 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 Names:
  • Orencia
Drug: tocilizumab
IL-6 receptor antagonist
Other Names:
  • RoActemra
Drug: tofacitinib/baricitinib
JAK inhibitor
Other Names:
  • Xeljanz/Olumiant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2025

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 4, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Survivin in Treatment

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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