PREDICT Therapy Selection for JAK, T-cell, or IL-6 Inhibitor Therapies Using a Molecular Signature Response Classifier (PREDICT)

Last updated: April 24, 2024
Sponsor: Scipher Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Joint Injuries

Arthritis And Arthritic Pain

Treatment

Lab Collection Only

Clinical Study ID

NCT06390709
PREDICT-001
  • Ages 18-100
  • All Genders

Study Summary

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 Criteria

Inclusion

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 classificationat Visit 1 and documented by enrolling PI.
  3. Patient has active RA, with moderate or high disease activity as confirmed by a CDAIscore of >10 at Visit 1.
  4. Patients must have a history of failure, contraindication, or intolerance to at leastone 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 (includingbiosimilars).
  7. JAK inhibitor therapy (only tofacitinib or upadacitinib)
  8. T-cell inhibitor therapy (abatacept)
  9. IL-6 inhibitor therapy (only tocilizumab)
  10. Concomitant treatments are permitted per standard of care and are not limited to thefollowing: a.csDMARD i.Methotrexate ii.Sulfasalazine iii.Leflunomide iv.Hydroxychloroquineb.Non-steroidal anti-inflammatory drugs c.Corticosteroids
  11. Patient may participate in another observational study.
  12. Patient is willing and able to complete the informed consent process and comply withall study procedures and visit schedule.

Exclusion

Exclusion Criteria:

  1. Patient has previously participated in a Scipher Medicine study (NETWORK-004, AIMs inRA, DRIVE, or INFORM).
  2. Patients who have been treated with an altMOA (non-TNFi therapy) therapy for RA priorto baseline (Visit 1).
  3. Women who are known to be pregnant or breast-feeding or plan to get pregnant duringthe study duration.
  4. Concurrent treatment with an investigational product or use of an investigationalproduct 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 andhistoplasmosis) and viral infection that, based on the Investigator's clinicalassessment, makes the patient an unsuitable candidate for the study. This includeshepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even asingle episode) herpes zoster, disseminated (even a single episode) herpes simplex, orhuman immunodeficiency virus (HIV).
  8. Patient with any known active malignancy except non-melanoma skin cancer, localizedprostate cancer treated with curative intent with no evidence of progression, low-riskor very low-risk (per standard guidelines) localized prostate cancer undersurveillance/watchful waiting (without intent to treat),or carcinoma in situ of anytype.

Study Design

Total Participants: 1100
Treatment Group(s): 1
Primary Treatment: Lab Collection Only
Phase:
Study Start date:
April 08, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Medvin Clinical Research//Amicus Arthritis

    Whittier, California 90602
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.