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

Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies (Increasing the Infliximab Dose or Introduction of Immunosuppressive Therapy) in Patients Chronic Inflammatory Bowel Diseases in Loss of Response to Infliximab

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.

Study Overview

• Status: Terminated
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Drug: Infliximab; Drug: Infliximab; Drug: Mercaptopurine; Drug: Azathioprine

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHRU, Hôpital Claude Huriez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Optimisation strategy; increase of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks	Drug: Infliximab; Infliximab 10mg/kg every 8 weeks; Drug: Infliximab; Infliximab 5mg/kg every 8 weeks
Other: Addition strategy; same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine	Drug: Infliximab; Infliximab 10mg/kg every 8 weeks; Drug: Infliximab; Infliximab 5mg/kg every 8 weeks; Drug: Mercaptopurine; 6-mercaptopurine 1 à 1,5 mg/kg; Other Names: addition strategy with 6-mercaptopurine in second intention; Drug: Azathioprine; Azathioprine 2 à 2.5mg/kg/j; Other Names: addition strategy with azathioprine in first intention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients in Clinical remission	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.	At Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients in deep remission	clinical remission associated with endoscopic remission (CDEIS <3 for CD patients or Mayo score<2 for UC patients)	At Week 52
Number of patient in remission and clinical response	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.	At week 16
infliximab blood concentration		Baseline, week 16 ad week 52
infliximab antibodies concentration		Baseline, week 16 ad week 52
economic criteria	medical fees in each arm	At week 52
number of patient with adverse effects and allergic reactions with infliximab		At week 52
Inflammatory bowel disease questionnaire (score IBDQ)	quality of life	Baseline and week 52

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Benjamin Pariente, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2017
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 12, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: ulcerative colitis; infliximab; crohn's disease; loss of response
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Dermatologic Agents; Infliximab; Mercaptopurine; Azathioprine
• Other Study ID Numbers: 2015_23; 2015-A00940-49 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No