Overview

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

Status:
Terminated
Trial end date:
2019-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Lille
Treatments:
Azathioprine
Infliximab
Mercaptopurine
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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