Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Synovial biopsy, Biologic therapy
Brief 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.
Interventions
DRUGAnti-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.
DRUGJAK 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.
Sponsors
Abu Dhabi Stem Cells Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DAS28 score | Baseline, Visit 3 (12 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in HAQ score | Baseline, Visit 3 (12 weeks) | 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. |
| Change in power Doppler activity | Baseline, Visit 3 (12 weeks) | 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. |
| Change in cellular phenotype | Baseline, Visit 3 (12 weeks) | Change in cellular phenotype compared to baseline. Estimation of change in the number of inflammatory cells as per the grading criteria. |
Countries
United Arab Emirates
Outcome results
None listed