Ulcerative ColitisREEFNCT04995783
Predicting Medication Response for Autoimmune Disease
An observational study of Ulcerative Colitis and Crohn's Disease, run by Coral Genomics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease, Psoriasis
- What is being tested?
- Coral FRS test
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will include adults 18 years and older who have been diagnosed with one of the four autoimmune conditions.
Who may be able to join
- Ulcerative Colitis, Crohn's Disease, Rheumatoid Arthritis, Psoriasis diagnosis
- On or about to begin a treatment for condition above
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Coral Genomics, Inc.
San Francisco, California, 94107
About this study
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.
- Conditions
- Ulcerative Colitis, Crohn's Disease, Psoriasis, Rheumatoid Arthritis
- Being tested
- Coral FRS test
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Psoriasis, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coral FRS testDiagnostic test
A novel clinical test to predict autoimmune medication response
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis | Not described Receives: Diagnostic Test: Coral FRS test | |
| Crohn's Disease | Not described Receives: Diagnostic Test: Coral FRS test | |
| Rheumatoid Arthritis | Not described Receives: Diagnostic Test: Coral FRS test | |
| Psoriasis | Not described Receives: Diagnostic Test: Coral FRS test | |
| Control | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of medication response
AUC measure
Measured: retrospective and 6 months prospectively
Secondary outcomes (2)
Prediction of disease severity
R-squared measure of predicting current disease severity measure
Measured: at enrollment
Classification of disease
AUC measure at determining the diagnosis/disease of a patient
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Sep 2020
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Why it stopped: Coral underwent an APA and is no longer in operation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coral Genomics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995783
- Sponsor's protocol ID
- 20201349
- Other IDs
- 2R44HG010445-02
- Acronym
- REEF
- Status last verified
- May 2023
- First submitted
- 30 Jul 2021
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in the NIH dbGAP repository
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Medication Response for Autoimmune Disease
- ClinicalTrials.gov ID
- NCT04995783
- Acronym / sponsor ID
- REEF / 20201349
- Conditions
- Ulcerative Colitis, Crohn's Disease, Psoriasis, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Coral underwent an APA and is no longer in operation
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Coral Genomics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Human Genome Research Institute (NHGRI)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include adults 18 years and older who have been diagnosed with one of the four autoimmune conditions.
Key inclusion criteria (2 listed)
- Ulcerative Colitis, Crohn's Disease, Rheumatoid Arthritis, Psoriasis diagnosis
- On or about to begin a treatment for condition above
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coral FRS testA novel clinical test to predict autoimmune medication response | Diagnostic test | Crohn's Disease, Psoriasis, Rheumatoid Arthritis, Ulcerative Colitis |
Primary outcome
Prediction of medication response
Time frame: retrospective and 6 months prospectively
AUC measure
2 secondary outcomes
Prediction of disease severity
Time frame: at enrollment
Classification of disease
Time frame: at enrollment
Results and safety
The study was stopped early (reason given: Coral underwent an APA and is no longer in operation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: Yes. Data will be shared in the NIH dbGAP repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn's Disease, run by Coral Genomics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Coral underwent an APA and is no longer in operation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of medication response (time frame: retrospective and 6 months prospectively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.