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A Trial for Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease

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ClinicalTrials.gov Identifier: NCT03843697
Recruitment Status : Not yet recruiting
First Posted : February 18, 2019
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tahel Ilan Ber, Oberon Sciences LTD

Brief Summary:
Trial for IBD patients non-responsive to biological drugs, using medical app reminding patients to take their physician-prescribed medications

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Device: An App for reminding patients to take their medication Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Device Feasibility
Official Title: A Controlled Trial for the Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Arm Intervention/treatment
Experimental: Patients with IBD who develop resistance to anti TNF
Patients with inflammatory bowel disease who developed partial or complete resistance to anti TNF based drugs
Device: An App for reminding patients to take their medication
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.
Other Name: Oberon APP




Primary Outcome Measures :
  1. 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;


Secondary Outcome Measures :
  1. Proportion of subjects achieving clinical remission or response without steroid rescue therapy during the study; [ Time Frame: 10 weeks ]
    The secondary efficacy outcome was the proportion of subjects with clinical response at week 10



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of CD or UC according to validated criteria, with a Crohn's Disease Activity Score (CDAI) of 200-450 at inclusion.
  2. Patients on a stable dose within the last 6 weeks of any type of anti TNF agent or any other biological agent
  3. 5-ASA (mesalamine), and immunomodulatory, or immunosuppressive agent, and symptomatic relief (anti-diarrheals) for patients are allowed in a stable dose (6 weeks).
  4. Non-smoking (by declaration) for a period of at least 6 months.
  5. 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.
  6. 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.
  7. No history of drug or alcohol abuse.
  8. 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.
  9. No clinically significant abnormalities in screening physical exam.
  10. Negative HIV, Hepatitis B and Hepatitis C serology tests within 2 years.
  11. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
  12. Patients must satisfy a medical examiner about their fitness to participate in the study.
  13. Patients must provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Patients with evidence of other serious infectious, autoimmune, hepatic, nephritic or systemic disease or compromised organ function.
  2. Patients with a present colostomy, ileostomy or subtotal colectomy with ileorectal anastomosis.
  3. Symptomatic stenosis or ileal strictures, x-ray evidence of fibrosed bowel.
  4. Patients presenting with, or with a history of persistent intestinal obstruction, bowel perforation, uncontrolled GI bleed or abdominal abscess or infection, toxic megacolon.
  5. Patients with fistulating CD.
  6. Short bowel syndrome.
  7. Patients with a history of GI tract malignancy or IBD-associated malignant changes in the intestines.
  8. Patients with any clinically significant abnormality upon physical examination or in the clinical laboratory test values.
  9. A change in the dose of the immunomodulatory or immunosuppressive drug within 6 weeks.
  10. 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
  11. Receipt of packed RBC's within 3 months prior to the first study dosing and throughout the study.
  12. Participation in another clinical trial within 30 days prior to first drug administration.
  13. Patients with an inability to communicate well with the PI and staff (i.e., language problem, poor mental development or impaired cerebral function).
  14. 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.
  15. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03843697


Contacts
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Contact: Tahel Ilan Ber, MD 972 53 803463 taheli@oberonsci.com

Sponsors and Collaborators
Tahel Ilan Ber

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Responsible Party: Tahel Ilan Ber, Chief Medical Officer, Oberon Sciences LTD
ClinicalTrials.gov Identifier: NCT03843697     History of Changes
Other Study ID Numbers: OS-002
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis