Trials Today

Eligibility

Eligible Ages

Over 18 Years

Eligible Sex

All

Accepts Healthy Volunteers

No

Criteria

For Subjects with Refractory Rheumatoid Arthritis (RA):

- Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria.

- Rheumatoid Factor (RF) or Anti Citrullinated Protein Antibody (ACPA) positive.

- High-sensitivity C-reactive protein (hs-CRP) > 3 mg/L or Erythrocyte Sedimentation
Rate (ESR) > 28 mm/hr.

- Have had prior treatment for a period of at least 12 weeks with a biologic disease
modifying anti-rheumatic drug and were deemed refractory by the treating physician.

- Minimum of six swollen joint counts (SJC) and six tender joint counts (TJC)
according to joint assessment.

For subjects with Sjögren's Disease (SjD)

- Prior diagnosis of Primary SjD as per 2016 ACR/EULAR criteria with confirmatory
diagnosis in the 24 weeks preceding screening.

- Total Clinical European League Against Rheumatism Sjogren's Syndrome Disease
Activity Index (clinESSDAI) > 6.

- Salivary Flow Rate > 0.1 mL/min on stimulation.

For subjects with Idiopathic Inflammatory Myopathies (IIMs)

- Presence of a positive autoantibody (ANA >1:80 or RNP or SSA/SSB or other myositis
specific autoantibodies.

- Refractory IIM as defined by inadequate response/intolerance to at least 3 months of
glucocorticoids and/or at least one other immunosuppressive.

- Muscle biopsy or muscle MRI to confirm IIM diagnosis, where applicable, within 12
months prior to enrollment.

For Subjects with Systemic Sclerosis (SSc)

- Diagnosis of SSc in accordance with the ACR/EULAR 2013 classification.

- Modified Rodnan skin score (mRSS) > 10.

- Initial confirmatory diagnosis within 8 years of screening.

- Refractory SSc as defined by inadequate response/intolerance to at least 3 months of
glucocorticoids and/or at least one other immunosuppressive.