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

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).

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Lab Collection Only

• Study Type: Observational
• Enrollment (Estimated): 1100

Contacts and Locations

• Study Contact: Name: April Cobb; Phone Number: 3363806400; Email: april.cobb@scipher.com

Study Locations

• United States
  • California
    • Whittier, California, United States, 90602
      • Recruiting
      • Medvin Clinical Research//Amicus Arthritis
      • Principal Investigator: Tien-I Karleen Su
      • Contact: Stesy Torres; Phone Number: 562-758-6600; Email: stesy@medvinresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

RA patients with moderate or high disease activity and are eligible for treatment with a JAK, T-cell, or IL-6 inhibitor therapy who are either naïve to biologic and targeted synthetic DMARDs or TNFi-exposed.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
JAK/T-cell/IL-6	Other: Lab Collection Only; 2 Paxgene and 1 SST tubes will be collected at 2 timepoints throughout the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of MSRC to predict the patients response	The rate of MSRC to predict the patients response status based on actual clinical disease activity measure at 6 months. Determine performance characteristics of the MSRC being developed, trained, and validated to predict a patient's response status to specific biologic or targeted therapies.	6 months

Collaborators and Investigators

• Sponsor: Scipher Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: PREDICT-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No