The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

— SYBRA  

Official title:

The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05379322
• Other study ID #: CT.006.1.1.SYBRA
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Abu Dhabi Stem Cells Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

SYBRA is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis that have failed disease-modifying drugs. The project has the potential to help change the current practice by offering the best treatment option. The decision to choose the best treatment for a particular patient is especially important in the context of the growing number of therapies available as a first-line option and the lack of specific biomarkers to predict response to treatment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject should be capable of consent

• Age 18 and older

• Classified as rheumatoid arthritis as per EULAR/ACR criteria 2010

• Failed one DMARD (Methotrexate, leflunomide, Sulfalsalazine, hydroxychloroquine)

• Can be on steroid dose <7.5mg

• Quantiferon negative

• Hepatitis B, C negative

• No recent history (<5y) of malignancy

Exclusion Criteria:

• Overlap syndrome

• Previously treated with a biological medication

• Heart failure NYHA III/IV

• Active tuberculosis

• Active infections

• Previous history of DVT, PE, or Stroke

• Other significant comorbidities that will prevent them from taking any biologic medication as per EULAR guidelines on treating rheumatoid arthritis 2020.

• Pregnancy

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Anti-TNF
Upon analysis of the sample, patients that are falling into specific phenotypes (diffuse myeloid or pauci-cellular phenotypes) will be assigned to receive anti-TNF as biologic DMARD medications.
• JAK inhibitor
Upon analysis of the sample, patients that are falling into specific phenotypes (lymphoid- myeloid or pauci-cellular phenotypes) will be assigned to receive JAK inhibitors as biologic DMARD medications.

Locations

Country	Name	City	State
United Arab Emirates	Abu Dhabi Stem Cells Center	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Abu Dhabi Stem Cells Center

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in DAS28 score	Change in DAS28 score indicating remission compared to baseline in at least 50% of patients, where DS28<2.6 indicated remission.; * DAS score: disease activity score, where <2.6 indicates remission, 2.6-3.2 low disease activity. 3.2-5.1 moderate disease activity; >5.1 high disease activity; higher values suggest worse outcomes.	Baseline, Visit 3 (12 weeks)
Secondary	Change in HAQ score	Significant decrease in HAQ score compared to baseline.; * HAQ (Health assessment questionnaire). Scores vary from 0-to 3. Higher scores are associated with worse outcomes.	Baseline, Visit 3 (12 weeks)
Secondary	Change in power Doppler activity	Change in power Doppler activity compared to a baseline where no power Doppler activity indicates remission. Measurement in Doppler activity on ultrasound using a grading system developed by EULAR.; * Global EULAR-OMERACT Synovitis Score: scores range from 0-3 for each scanned joint. Higher scores correlate with worse outcomes.	Baseline, Visit 3 (12 weeks)
Secondary	Change in cellular phenotype	Change in cellular phenotype compared to baseline. Estimation of change in the number of inflammatory cells as per the grading criteria.	Baseline, Visit 3 (12 weeks)