Predicting Medication Response for Autoimmune Disease | NCT04995783

Studies
Predicting Medication Response for Autoimmune Disease

NCT04995783

Sponsor

Coral Genomics, Inc.

Status

Terminated

Last Update Posted

May 19, 2023Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Ulcerative Colitis
Crohn's Disease
Psoriasis
Rheumatoid Arthritis

Interventions

Coral FRS test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R44HG010445-02	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Coral underwent an APA and is no longer in operation

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Aug 1, 2022Actual

First Submitted Date

Jul 30, 2021

First Submission Date that Met QC Criteria

Jul 30, 2021

First Posted Date

Aug 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 18, 2023

Last Update Posted Date

May 19, 2023Actual

Name	Class
National Human Genome Research Institute (NHGRI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Coral FRS test	Diagnostic Test	A novel clinical test to predict autoimmune medication response	Crohn's Disease Psoriasis Rheumatoid Arthritis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Coral Genomics, Inc.		San Francisco	California	94107	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be shared in the NIH dbGAP repository

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003093	Colitis, Ulcerative
D003424	Crohn Disease
D011565	Psoriasis
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided