REEF: Predicting Medication Response for Autoimmune Disease

• Sponsor: Coral Genomics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04995783
• Collaborator: National Human Genome Research Institute (NHGRI) (NIH)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 28
• Patients Per Site Per Month: 35.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis; Crohn's Disease; Psoriasis; Rheumatoid Arthritis	Diagnostic Test: Coral FRS test

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Predicting Medication Response for Autoimmune Disease
• Actual Study Start Date: Sep 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Ulcerative Colitis	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
Rheumatoid Arthritis	Diagnostic Test: Coral FRS test; A novel clinical test to predict autoimmune medication response
Psoriasis	Diagnostic Test: Coral FRS test; A novel clinical test to predict autoimmune medication response
Control

Outcome Measures

Primary Outcome Measures

1. Prediction of medication response [retrospective and 6 months prospectively]

   AUC measure

Secondary Outcome Measures

1. Prediction of disease severity [at enrollment]

   R-squared measure of predicting current disease severity measure

2. Classification of disease [at enrollment]

   AUC measure at determining the diagnosis/disease of a patient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ulcerative Colitis, Crohn's Disease, Rheumatoid Arthritis, Psoriasis diagnosis

• On or about to begin a treatment for condition above

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coral Genomics, Inc.	San Francisco	California	United States	94107

Sponsors and Collaborators

• Coral Genomics, Inc.
• National Human Genome Research Institute (NHGRI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coral Genomics, Inc.
• ClinicalTrials.gov Identifier: NCT04995783
• Other Study ID Numbers: 20201349; 2R44HG010445-02
• First Posted: Aug 9, 2021
• Last Update Posted: Aug 9, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease; Psoriasis; Autoimmune Diseases

Study Results

No Results Posted as of Aug 9, 2021