NCT04995783

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

July 30, 2021

Last Update Submit

May 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prediction of medication response

    AUC measure

    retrospective and 6 months prospectively

Secondary Outcomes (2)

  • Prediction of disease severity

    at enrollment

  • Classification of disease

    at enrollment

Study Arms (5)

Ulcerative Colitis

Diagnostic Test: Coral FRS test

Crohn's Disease

Diagnostic Test: Coral FRS test

Rheumatoid Arthritis

Diagnostic Test: Coral FRS test

Psoriasis

Diagnostic Test: Coral FRS test

Control

Interventions

Coral FRS testDIAGNOSTIC_TEST

A novel clinical test to predict autoimmune medication response

Crohn's DiseasePsoriasisRheumatoid ArthritisUlcerative Colitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coral Genomics, Inc.

San Francisco, California, 94107, United States

Location

MeSH Terms

Conditions

Colitis, UlcerativeCrohn DiseasePsoriasisArthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal DiseasesSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2021

First Posted

August 9, 2021

Study Start

September 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Data will be shared in the NIH dbGAP repository

Locations