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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 : Unknown
Verified February 2019 by Tahel Ilan Ber, Oberon Sciences LTD.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE December 21, 2018
First Posted Date  ICMJE February 18, 2019
Last Update Posted Date February 18, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
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;
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial for Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease
Official Title  ICMJE A Controlled Trial for the Prevention of Loss of the Effect of Biological Drugs in Patients With Inflammatory Bowel Disease
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
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
Condition  ICMJE Inflammatory Bowel Diseases
Intervention  ICMJE 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
Study Arms  ICMJE 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
Intervention: Device: An App for reminding patients to take their medication
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 13, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03843697
Other Study ID Numbers  ICMJE OS-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tahel Ilan Ber, Oberon Sciences LTD
Study Sponsor  ICMJE Tahel Ilan Ber
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oberon Sciences LTD
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP