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

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: methotrexate; Drug: sulfasalazine; Drug: abatacept; Drug: tocilizumab; Drug: tofacitinib/baricitinib

• Registration Number: NCT03440892
• Lead Sponsor: Vastra Gotaland Region

Brief Summary

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

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 Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-14
• Study First Posted: 2018-02-22
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-04
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	tofacitinib/baricitinib	-
1	methotrexate	-
1	sulfasalazine	-
1	abatacept	-
1	tocilizumab	-

Primary Outcome Measures

Name	Time	Method
Survivin status	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

Name	Time	Method
Disease activity (DAS28)	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
Response to treatment	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

Trial Locations

Locations (1)

Dept of Rheumatology and Inflammation research; 🇸🇪 Gothenburg, Sweden