Overview

Prospective, multi-center-observational study conducted within the US, collecting patient samples for research and development to train, test, and validate precision medicine classifiers. These molecular signature response classifiers (MSRC) aim to predict response status to JAK, T-cell, and IL-6 inhibitor therapies in patients with rheumatoid arthritis (RA).

Eligibility

Inclusion Criteria:

1. Patient is eighteen years of age, or older (≥18) at time of consent.
2. Patient must meet the criteria for RA as defined by the 2010ACR/EULAR classification at Visit 1 and documented by enrolling PI.
3. Patient has active RA, with moderate or high disease activity as confirmed by a CDAI score of >10 at Visit 1.
4. Patients must have a history of failure, contraindication, or intolerance to at least one csDMARD therapy.
5. Patient must be b/tsDMARD-naïve or TNFi-exposed prior to baseline visit only.
6. Patient must be initiating one of the following listed therapies (including biosimilars).
   1. JAK inhibitor therapy (only tofacitinib or upadacitinib)
   2. T-cell inhibitor therapy (abatacept)
   3. IL-6 inhibitor therapy (only tocilizumab)
7. Concomitant treatments are permitted per standard of care and are not limited to the

   following

             a.csDMARD i.Methotrexate ii.Sulfasalazine iii.Leflunomide iv.Hydroxychloroquine
             b.Non-steroidal anti-inflammatory drugs c.Corticosteroids
          8. Patient may participate in another observational study.
          9. Patient is willing and able to complete the informed consent process and comply with
             all study procedures and visit schedule.
        Exclusion Criteria:
          1. Patient has previously participated in a Scipher Medicine study (NETWORK-004, AIMs in
             RA, DRIVE, or INFORM).
          2. Patients who have been treated with an altMOA (non-TNFi therapy) therapy for RA prior
             to baseline (Visit 1).
          3. Women who are known to be pregnant or breast-feeding or plan to get pregnant during
             the study duration.
          4. Concurrent treatment with an investigational product or use of an investigational
             product within 28 days of Visit 1.
          5. The use of RA therapies outside of an FDA approved indication.
          6. Patient is currently receiving systemic antimicrobial treatment for viral, bacterial,
             fungal, or parasitic infection at the time of baseline visit (Visit 1).
          7. Any known active, chronic, or recurrent invasive infection (e.g., listeriosis and
             histoplasmosis) and viral infection that, based on the Investigator's clinical
             assessment, makes the patient an unsuitable candidate for the study. This includes
             hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a
             single episode) herpes zoster, disseminated (even a single episode) herpes simplex, or
             human immunodeficiency virus (HIV).
          8. Patient with any known active malignancy except non-melanoma skin cancer, localized
             prostate cancer treated with curative intent with no evidence of progression, low-risk
             or very low-risk (per standard guidelines) localized prostate cancer under
             surveillance/watchful waiting (without intent to treat),or carcinoma in situ of any
             type.