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

Abu Dhabi Stem Cells Center

Status and phase: Withdrawn; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Anti-TNF; Drug: JAK inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT05379322

CT.006.1.1.SYBRA

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Group A (Anti-TNF)

Experimental group

Description:

Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the diffuse myeloid phenotype will be assigned to receive anti-TNF medication at the discretion of the treating physician.

Treatment:

Drug: Anti-TNF

Group B (JAK inhibitor)

Experimental group

Description:

Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the lymphoid- myeloid phenotype will be assigned to receive JAK inhibitor medication at the discretion of the treating physician.

Treatment:

Drug: JAK inhibitor

Group C (Anti-TNF or JAK inhibitor)

Experimental group

Description:

Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the pauci-cellular phenotype will be randomized to either anti-TNF or JAK inhibitor medication 1:1.

Treatment:

Drug: JAK inhibitor

Drug: Anti-TNF