RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-04-08

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06390709

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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.	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.

Inclusion Criteria

Exclusion 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:
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.

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.

Contacts and Locations

Study Contact

April Cobb

CONTACT

3363806400

april.cobb@scipher.com

Study Locations (Sites)

Medvin Clinical Research//Amicus Arthritis

Whittier, California, 90602

United States

Collaborators and Investigators

Sponsor: Scipher Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-08

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-04-08

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Rheumatoid Arthritis