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

Rheumatoid Arthritis Clinical Trial

— SurviTreat  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03440892
• Other study ID #: Survivin in Treatment
• Status: Recruiting
• Start date: November 1, 2017
• Est. completion date: January 2025

Study information

• Verified date: May 2022
• Source: Vastra Gotaland Region
• Contact: Maria Bokarewa, MD
• Email: maria.bokarewa[@]rheuma.gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• methotrexate
folate antagonist
• sulfasalazine
Immunomodulatory
• abatacept
Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4)
• tocilizumab
IL-6 receptor antagonist
• tofacitinib/baricitinib
JAK inhibitor

Locations

Country	Name	City	State
Sweden	Dept of Rheumatology and Inflammation research	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survivin status	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	Disease activity (DAS28)	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
Secondary	Response to treatment	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