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Predicting Medication Response for Autoimmune Disease (REEF)

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ClinicalTrials.gov Identifier: NCT04995783
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : August 9, 2021
Sponsor:
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Coral Genomics, Inc.

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
Ulcerative Colitis Crohn's Disease Psoriasis Rheumatoid Arthritis Diagnostic Test: Coral FRS test

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

Resource links provided by the National Library of Medicine


Group/Cohort 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



Primary Outcome Measures :
  1. Prediction of medication response [ Time Frame: retrospective and 6 months prospectively ]
    AUC measure


Secondary Outcome Measures :
  1. Prediction of disease severity [ Time Frame: at enrollment ]
    R-squared measure of predicting current disease severity measure

  2. Classification of disease [ Time Frame: at enrollment ]
    AUC measure at determining the diagnosis/disease of a patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04995783


Contacts
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Contact: Atray Dixit, PhD ‪872-267-2549‬ atray@coralgenomics.com

Locations
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United States, California
Coral Genomics, Inc. Recruiting
San Francisco, California, United States, 94107
Contact: Atray Dixit    ‪872-267-2549‬      
Sponsors and Collaborators
Coral Genomics, Inc.
National Human Genome Research Institute (NHGRI)
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Responsible Party: Coral Genomics, Inc.
ClinicalTrials.gov Identifier: NCT04995783    
Other Study ID Numbers: 20201349
2R44HG010445-02 ( U.S. NIH Grant/Contract )
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared in the NIH dbGAP repository

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Psoriasis
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases