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

Not Applicable

Terminated

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Mercaptopurine; Drug: Infliximab; Drug: Azathioprine

• Registration Number: NCT03370601
• Lead Sponsor: University Hospital, Lille

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 immunosuppressant may be more efficient at long term and is less expensive.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-03
• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-12
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Addition strategy	Mercaptopurine	same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine
Optimisation strategy	Infliximab	increase of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks
Addition strategy	Infliximab	same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine
Addition strategy	Azathioprine	same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine

Primary Outcome Measures

Name	Time	Method
Number of patients in Clinical remission	At Week 52	the clinical remission is defined by Harvey Bradshaw (HBI) Index \< 4 for Crohn's disease or Simple Clinical Colitis Activity Index (SCCAI)\<4 for ulcerative colitis.

Secondary Outcome Measures

Name	Time	Method
number of patient with adverse effects and allergic reactions with infliximab	At week 52
economic criteria	At week 52	medical fees in each arm
Number of patients in deep remission	At Week 52	clinical remission associated with endoscopic remission (CDEIS \<3 for CD patients or Mayo score\<2 for UC patients)
Number of patient in remission and clinical response	At week 16	clinical response is defined as a decrease of at least 3 points of HBI for CD patients or SCCAI for UC patients compared to baseline (week 0).; Simple Clinical Colitis Activity Index (SCCAI)\<4 for ulcerative colitisHBI pour MC et SCCAI pour RCH \<4 associated at CRP \< 5 mg/dl.
infliximab blood concentration	Baseline, week 16 ad week 52
infliximab antibodies concentration	Baseline, week 16 ad week 52
Inflammatory bowel disease questionnaire (score IBDQ)	Baseline and week 52	quality of life

Trial Locations

Locations (1)

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France