Status:
TERMINATED
Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases
Lead Sponsor:
University Hospital, Lille
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 immun...
Eligibility Criteria
Inclusion
- patients with ulcerative colitis or crohn's disease
- treated with infliximab (5mg/kg per 8 weeks) and with loss of response after at least 4 infusions of infliximab
- active disease ( HBI \> 5 for CD patients or SCCAI\> 6 for UC patients)
- patients treated with infliximab only at the time of loss of response
Exclusion
- Patients with CD with ano perineal lesions and without luminal activity
- patients treated with cortico steroids and having had history of intolerance to azathioprin, 6-mercaptopurine or methotrexate
- patients with acute severe flare (HBI\>12 for CD patients and Lichtiger score \> 10 for UC patients)
- pregnant female
- patients with anal disease alone
Key Trial Info
Start Date :
January 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03370601
Start Date
January 3 2017
End Date
January 1 2019
Last Update
February 15 2019
Active Locations (1)
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1
CHRU, Hôpital Claude Huriez
Lille, France