Predicting Medication Response for Autoimmune Disease (REEF)

May 18, 2023 updated by: Coral Genomics, Inc.

Coral is conducting a large study comparing and predicting the relative effectiveness of different medications for autoimmune patients.

Patients with Inflammatory Bowel Disease (IBD) who have been diagnosed with either Ulcerative Colitis or Crohn's Disease and are undergoing treatment are eligible to participate.

Patients with Rheumatoid Arthritis (RA) and Psoriasis (Ps) will also be enrolled.

A novel clinical test will be performed to predict the responsiveness of a particular patient to different immune modulating therapies used in these conditions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

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

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94107
        • Coral Genomics, Inc.

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population will include adults 18 years and older who have been diagnosed with one of the four autoimmune conditions.

Description

Inclusion Criteria:

  • Ulcerative Colitis, Crohn's Disease, Rheumatoid Arthritis, Psoriasis diagnosis
  • On or about to begin a treatment for condition above

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
Intervention / Treatment
Control
Psoriasis
Diagnostic test: Coral FRS test
A novel clinical test to predict autoimmune medication response
Rheumatoid Arthritis
Diagnostic test: Coral FRS test
A novel clinical test to predict autoimmune medication response
Crohn's Disease
Diagnostic test: Coral FRS test
A novel clinical test to predict autoimmune medication response
Ulcerative Colitis
Diagnostic test: Coral FRS test
A novel clinical test to predict autoimmune medication response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of medication response
Time Frame: retrospective and 6 months prospectively
AUC measure
retrospective and 6 months prospectively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of disease severity
Time Frame: at enrollment
R-squared measure of predicting current disease severity measure
at enrollment
Classification of disease
Time Frame: at enrollment
AUC measure at determining the diagnosis/disease of a patient
at enrollment

Collaborators and Investigators

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

Sponsor

Coral Genomics, Inc.

Collaborators

National Human Genome Research Institute (NHGRI)

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)

September 1, 2020

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

July 30, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201349
  • 2R44HG010445-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared in the NIH dbGAP repository

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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