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

Tahel Ilan Ber0 sites20 target enrollmentMarch 1, 2019

ConditionsInflammatory Bowel Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inflammatory Bowel Diseases
Sponsor: Tahel Ilan Ber
Enrollment: 20
Primary Endpoint: Proportion of subjects with reduction chron's disease activity index score more than 100 points during the study;
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2019

End Date

January 1, 2020

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Tahel Ilan Ber

Responsible Party

Sponsor Investigator

Principal Investigator

Tahel Ilan Ber

Chief Medical Officer

Oberon Sciences LTD

Eligibility Criteria

Inclusion Criteria

•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.
•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.

Exclusion Criteria

•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.
•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