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

April 24, 2024 updated by: Scipher Medicine
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Whittier, California, United States, 90602
        • Recruiting
        • Medvin Clinical Research//Amicus Arthritis
        • Principal Investigator:
          • Tien-I Karleen Su
        • Contact:

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The rate of MSRC to predict the patients response
Time Frame: 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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