Predicting Medication Response for Autoimmune Disease

Rheumatoid Arthritis Clinical Trial

— REEF  

Official title:

Predicting Medication Response for Autoimmune Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04995783
• Other study ID #: 20201349
• Secondary ID: 2R44HG010445-02
• Status: Terminated
• Start date: September 1, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: May 2023
• Source: Coral Genomics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• On or about to begin a treatment for condition above

Related Conditions & MeSH terms

• Autoimmune Diseases
• Crohn Disease
• Crohn's Disease
• Psoriasis
• Rheumatoid Arthritis
• Ulcerative Colitis

Intervention

Diagnostic Test:
• Coral FRS test
A novel clinical test to predict autoimmune medication response

Locations

Country	Name	City	State
United States	Coral Genomics, Inc.	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Coral Genomics, Inc.	National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of medication response	AUC measure	retrospective and 6 months prospectively
Secondary	Prediction of disease severity	R-squared measure of predicting current disease severity measure	at enrollment
Secondary	Classification of disease	AUC measure at determining the diagnosis/disease of a patient	at enrollment