Inflammatory Bowel DiseasesNCT03843697
A Trial for Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease
A study testing An App for reminding patients to take their medication in people with Inflammatory Bowel Diseases, run by Tahel Ilan Ber.
Trial summary
Trial for IBD patients non-responsive to biological drugs, using medical app reminding patients to take their physician-prescribed medications Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- An App for reminding patients to take their medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2019to 1 Jan 2020
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CD or UC according to validated criteria, with a Crohn's Disease Activity Score (CDAI) of 200-450 at inclusion.
- Patients on a stable dose within the last 6 weeks of any type of anti TNF agent or any other biological agent
- 5-ASA (mesalamine), and immunomodulatory, or immunosuppressive agent, and symptomatic relief (anti-diarrheals) for patients are allowed in a stable dose (6 weeks).
- Non-smoking (by declaration) for a period of at least 6 months.
- Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
- No known history of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, primary hematopoietic disease, neoplasm, or any other clinically significant medical disorder other than Crohn's disease and its complications, which in the investigator's judgment contraindicate administration of the study medications.
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- No history of drug or alcohol abuse.
- Screening tests must meet the following criteria: HGB ≥8.5 g/dL, platelets ≥ 100,000/ mm³, WBC: 3500-12,000/mm³, serum albumin above 2.5 g/dL, amylase, lipase and total bilirubin within normal limits. ALT, AST, alkaline phosphatase up to 1.5 times normal limits.
- No clinically significant abnormalities in screening physical exam.
- Negative HIV, Hepatitis B and Hepatitis C serology tests within 2 years.
- Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Patients must satisfy a medical examiner about their fitness to participate in the study.
- Patients must provide written informed consent to participate in the study.
Who cannot join
- Patients with evidence of other serious infectious, autoimmune, hepatic, nephritic or systemic disease or compromised organ function.
- Patients with a present colostomy, ileostomy or subtotal colectomy with ileorectal anastomosis.
- Symptomatic stenosis or ileal strictures, x-ray evidence of fibrosed bowel.
- Patients presenting with, or with a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection, toxic megacolon.
- Patients with fistulating CD.
- Short bowel syndrome.
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- Patients with a history of GI tract malignancy or IBD-associated malignant changes in the intestines.
- Patients with any clinically significant abnormality upon physical examination or in the clinical laboratory test values.
- A change in the dose of the immunomodulatory or immunosuppressive drug within 6 weeks.
- Over-the-counter drugs, including herbal medications, and prescription drugs (other than those listed above) are not allowed for 7 days prior to first study dosing and throughout the duration of the study
- Receipt of packed RBC's within 3 months prior to the first study dosing and throughout the study.
- Participation in another clinical trial within 30 days prior to first drug administration.
- Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function).
- Patients with any acute medical situation (e.g. acute infection) within 48 hours of first dosing session, which is considered of significance by the Principal Investigator.
- Patients who will be unavailable for the duration of the trial, are likely to be noncompliant with the protocol, or who are felt to be unsuitable by the PI for any other reason.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Controlled Trial for the Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease
Trial for IBD patients non-responsive to biological drugs, using medical app reminding patients to take their physician-prescribed medications
Read the detailed description
Patients with IBD who developed loss of response to anti-TNF based medications will receive a cell phone based app that will remind them to take the drug with an approved dosing range.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- An App for reminding patients to take their medication
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An App for reminding patients to take their medicationDevice
Also called Oberon APP
Open-label, single-center study, up to 20 adults (>18) male and female with inflammatory bowel disease (chorn's disease, ulcerative colitis), unresponsive to biological drugs, will participate in a 4-week observation period during which no change in drugs is permitted. The patients will then begin 10-week treatment by taking their medications according to a semi-random schedule that is pre-set for them by the physician using the same drugs the patient is taking and only changing the dose and times of taking them each day while keeping the drugs within their therapeutic window.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IBD who develop resistance to anti TNF | Experimental | Patients with inflammatory bowel disease who developed partial or complete resistance to anti TNF based drugs Receives: Device: An App for reminding patients to take their medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study;
Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study;
Measured: 10 weeks
Secondary outcomes (1)
Proportion of subjects achieving clinical remission or response without steroid rescue therapy during the study;
The secondary efficacy outcome was the proportion of subjects with clinical response at week 10
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will assess the effect of adding an app which reminds to take an approved therapy in patients who are already on the drug without a change of the physician's predetermined regimen
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tahel Ilan Ber
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Tahel Ilan Ber, Oberon Sciences LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843697
- Sponsor's protocol ID
- OS-002
- Status last verified
- Feb 2019
- First submitted
- 21 Dec 2018
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azmanov H, Ross EL, Ilan Y. Establishment of an Individualized Chronotherapy, Autonomic Nervous System, and Variability-Based Dynamic Platform for Overcoming the Loss of Response to Analgesics. Pain Physician. 2021 May;24(3):243-252.
PubMed 33988944
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial for the Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03843697
- Acronym / sponsor ID
- OS-002
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tahel Ilan BerIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 18 Feb 2019 (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.
Trial for IBD patients non-responsive to biological drugs, using medical app reminding patients to take their physician-prescribed medications
Detailed description
Patients with IBD who developed loss of response to anti-TNF based medications will receive a cell phone based app that will remind them to take the drug with an approved dosing range.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will assess the effect of adding an app which reminds to take an approved therapy in patients who are already on the drug without a change of the physician's predetermined regimen
| Arm | Type | Receives |
|---|---|---|
| Patients with IBD who develop resistance to anti TNF | Experimental | Device: An App for reminding patients to take their medicationPatients with inflammatory bowel disease who developed partial or complete resistance to anti TNF based drugs |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Diagnosis of CD or UC according to validated criteria, with a Crohn's Disease Activity Score (CDAI) of 200-450 at inclusion.
- Patients on a stable dose within the last 6 weeks of any type of anti TNF agent or any other biological agent
- 5-ASA (mesalamine), and immunomodulatory, or immunosuppressive agent, and symptomatic relief (anti-diarrheals) for patients are allowed in a stable dose (6 weeks).
- Non-smoking (by declaration) for a period of at least 6 months.
- Females of childbearing potential must be non-pregnant (as determined by a serum pregnancy test at screening and again, prior to each dosing session) and agree to use adequate contraceptive means throughout the study.
Key exclusion criteria (15 listed)
- Patients with evidence of other serious infectious, autoimmune, hepatic, nephritic or systemic disease or compromised organ function.
- Patients with a present colostomy, ileostomy or subtotal colectomy with ileorectal anastomosis.
- Symptomatic stenosis or ileal strictures, x-ray evidence of fibrosed bowel.
- Patients presenting with, or with a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection, toxic megacolon.
- Patients with fistulating CD.
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 |
|---|---|---|
| An App for reminding patients to take their medicationAlso: Oberon APPOpen-label, single-center study, up to 20 adults (>18) male and female with inflammatory bowel disease (chorn's disease, ulcerative colitis), unresponsive to biological drugs, will participate in a 4-week observation period during which no change in drugs is permitted. The patients will then begin 10-week treatment by taking their medications according to a semi-random schedule that is pre-set for them by the physician using the same drugs the patient is taking and only changing the dose and times of taking them each day while keeping the drugs within their therapeutic window. | Device | Patients with IBD who develop resistance to anti TNF |
Primary outcome
Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study;
Time frame: 10 weeks
Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study;
1 secondary outcome
Proportion of subjects achieving clinical remission or response without steroid rescue therapy during the study;
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Derived from this study: PubMed 33988944Azmanov H, Ross EL, Ilan Y. Establishment of an Individualized Chronotherapy, Autonomic Nervous System, and Variability-Based Dynamic Platform for Overcoming the Loss of Response to Analgesics. Pain Physician. 2021 May;24(3):243-252.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing An App for reminding patients to take their medication in people with Inflammatory Bowel Diseases, run by Tahel Ilan Ber.
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 13 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tahel Ilan Ber, MD (972 53 803463, taheli@oberonsci.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study; (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03843697, which also lists 1 linked publication.
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 18 Feb 2019.