Crohn's DiseasePhase 4NCT02392286
Corticosteroid Dosage for Crohn's Disease Flare
A Phase 4 study testing Corticosteroid in people with Crohn's Disease and Inflammatory Bowel Disease, run by Yale University at 1 site in United States.
Trial summary
Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, Inflammatory Bowel Disease
- What is being tested?
- Corticosteroid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 19 Dec 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Established diagnosis of Crohn's disease
- Diagnosis of Crohn's flare
- Decision by treating gastroenterologist to start corticosteroid therapy
Who cannot join
- Patients in whom corticosteroid therapy is contraindicated: immunocompromised (active cancer on chemotherapy or radiation treatment), severe liver disease (decompensated cirrhosis, active alcoholic hepatitis), end-stage renal disease on dialysis, AIDS or AIDS-defining illness; myocardial infarction within the past year; NYHA Class 4 heart failure
- Patients on systemic corticosteroid therapy currently or within the past 8 weeks
- Patients not on stable doses of immunomodulators or biologics for at least 8 weeks
- Infectious colitis (e.g., C. difficile, CMV, HSV)
- Systemic infections (bacteremia, fungal infections)
- Fulminant Crohn's disease
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- Patients who require imminent surgery
- Abscess
- Pregnancy
- Weight <35 kg
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares
Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.
Read the detailed description
- Determine if weight-based corticosteroid (1mg/kg daily) induces remission at a greater rate than fixed corticosteroid dosage.
- Determine if weight-based corticosteroid is associated with greater rate of adverse events than fixed corticosteroid dosage.
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Being tested
- Corticosteroid
- Keywords
- Corticosteroid
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorticosteroidDrug
Also called Prednisone, Methylprednisolone
Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Weight-based | Active comparator | Corticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily. Receives: Drug: Corticosteroid |
| Fixed dose | Active comparator | Corticosteroid dose fixed at equivalent to 40mg prednisone daily. Receives: Drug: Corticosteroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Remission at End of 2 Weeks
Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. <5 is determined to be remission.
Measured: 2 weeks
Secondary outcomes (5)
Number of Participants With Response at End of 2 Weeks
Number of participants with at least a 3-point drop in Harvey-Bradshaw Index at end of 2 weeks
Measured: 2 weeks
Number of Participants With Response or Remission at End of 1 Week
Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 1 week
Measured: 1 week
Number of Participants With Response or Remission at End of 4 Weeks
Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 4 weeks
Measured: 4 weeks
Number of Participants With Response or Remission at End of 12 Weeks
Number of participants with Harvey-Bradshaw Index <5 or with a drop in Harvey-Bradshaw Index of at least 3 points at end of 12 weeks
Measured: 12 weeks
Number of Participants With Corticosteroid-associated Side Effects
Number of participants with side effects that may be associated with use of corticosteroids such as mood swings, sleep disturbance, edema, acne, bruising, myalgias.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion19 Dec 2016
- Study completion19 Dec 2016
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loren Laine, MD, Principal investigator, Yale University, Section of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392286
- Sponsor's protocol ID
- 1501015143
- Status last verified
- Aug 2021
- First submitted
- 12 Mar 2015
- Last updated
- 9 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Trial Comparing the Efficacy of Body-weight Based Versus Fixed Corticosteroid Dosage on Remission in Patients With Moderate to Severe Crohn's Disease Flares
- ClinicalTrials.gov ID
- NCT02392286
- Acronym / sponsor ID
- 1501015143
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease
- Keywords
- Corticosteroid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Dec 2016 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective randomized comparative effectiveness trial designed to compare fixed dosing and weight-based dosing of corticosteroids in patients with Crohn's disease flares.
Detailed description
- Determine if weight-based corticosteroid (1mg/kg daily) induces remission at a greater rate than fixed corticosteroid dosage.
- Determine if weight-based corticosteroid is associated with greater rate of adverse events than fixed corticosteroid dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-based | Active comparator | Drug: CorticosteroidCorticosteroid dose weight-based at equivalent to 1mg/kg prednisone daily. |
| Fixed dose | Active comparator | Drug: CorticosteroidCorticosteroid dose fixed at equivalent to 40mg prednisone daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18
- Established diagnosis of Crohn's disease
- Diagnosis of Crohn's flare
- Decision by treating gastroenterologist to start corticosteroid therapy
Key exclusion criteria (10 listed)
- Patients in whom corticosteroid therapy is contraindicated: immunocompromised (active cancer on chemotherapy or radiation treatment), severe liver disease (decompensated cirrhosis, active alcoholic hepatitis), end-stage renal disease on dialysis, AIDS or AIDS-defining illness; myocardial infarction within the past year; NYHA Class 4 heart failure
- Patients on systemic corticosteroid therapy currently or within the past 8 weeks
- Patients not on stable doses of immunomodulators or biologics for at least 8 weeks
- Infectious colitis (e.g., C. difficile, CMV, HSV)
- Systemic infections (bacteremia, fungal infections)
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 |
|---|---|---|
| CorticosteroidAlso: Prednisone, MethylprednisoloneSubjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy. | Drug | Fixed dose, Weight-based |
Primary outcome
Number of Participants in Remission at End of 2 Weeks
Time frame: 2 weeks
Number of participants with Harvey Bradshaw Index < 5 at end of 2 weeks. The minimum score obtainable is 0, suggesting absence of disease or remission, while the maximum score obtainable goes beyond 18 points, depending on the number of stools the patient identifies per day (because 1 point is given for each stool in a day, there is no specific maximum score. A higher score represents more severe disease. <5 is determined to be remission.
5 secondary outcomes
Number of Participants With Response at End of 2 Weeks
Time frame: 2 weeks
Number of Participants With Response or Remission at End of 1 Week
Time frame: 1 week
Number of Participants With Response or Remission at End of 4 Weeks
Time frame: 4 weeks
Number of Participants With Response or Remission at End of 12 Weeks
Time frame: 12 weeks
Number of Participants With Corticosteroid-associated Side Effects
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Loren Laine, MD principal investigator
Yale University, Section of Digestive Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corticosteroid in people with Crohn's Disease and Inflammatory Bowel Disease, run by Yale University 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 4 inclusion and 10 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 9 Aug 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants in Remission at End of 2 Weeks (time frame: 2 weeks). 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 9 Aug 2021.