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

University Hospital, Lille

Status: Terminated

Conditions: Inflammatory Bowel Diseases

Treatments: Drug: Azathioprine; Drug: Infliximab; Drug: Mercaptopurine

Study type: Interventional

Funder types: Other

Identifiers

NCT03370601

2015-A00940-49 (Other Identifier)

2015_23

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

9 participants in 2 patient groups

Optimisation strategy

Other group

Description:

increase of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks

Treatment:

Drug: Infliximab

Addition strategy

Other group

Description:

same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine

Treatment:

Drug: Azathioprine

Drug: Mercaptopurine

Drug: Infliximab