Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases

NCT03370601 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-02-15

No results posted yet for this study

Summary

This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DRUG

Infliximab

Infliximab 10mg/kg every 8 weeks

DRUG

Mercaptopurine

6-mercaptopurine 1 à 1,5 mg/kg

DRUG

Azathioprine

Azathioprine 2 à 2.5mg/kg/j

DRUG

Infliximab

Infliximab 5mg/kg every 8 weeks

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Benjamin Pariente, MD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-03
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03370601 on ClinicalTrials.gov