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

NCT ID: NCT03843697

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-01-01

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.

Conditions

Inflammatory Bowel Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

An App for reminding patients to take their medication

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Oberon APP

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tahel Ilan Ber

INDUSTRY

Sponsor Role: lead

Responsible Party

Tahel Ilan Ber

Chief Medical Officer

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Tahel Ilan Ber, MD

Role: CONTACT

taheli@oberonsci.com

972 53 803463

References

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.

Reference Type: DERIVED

PMID: 33988944 (View on PubMed)

Other Identifiers

OS-002

Identifier Type: -

Identifier Source: org_study_id