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

Abu Dhabi Stem Cells Center

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Rheumatoid Arthritis

Interventions

Anti-TNFDRUG

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 inhibitorDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Abu Dhabi Stem Cells Center

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Visit 3 (12 weeks)

Secondary Outcomes

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.

Time frame: Baseline, Visit 3 (12 weeks)

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.

Time frame: Baseline, Visit 3 (12 weeks)

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.

Time frame: Baseline, Visit 3 (12 weeks)

Data from ClinicalTrials.gov

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