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

Primary Purpose

Inflammatory Bowel Diseases

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Infliximab
Mercaptopurine
Azathioprine
Infliximab
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases focused on measuring crohn's disease, ulcerative colitis, infliximab, loss of response

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHRU, Hôpital Claude Huriez

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Optimisation strategy

Addition strategy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients in deep remission
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
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
infliximab antibodies concentration
economic criteria
medical fees in each arm
number of patient with adverse effects and allergic reactions with infliximab
Inflammatory bowel disease questionnaire (score IBDQ)
quality of life

Full Information

First Posted
December 7, 2017
Last Updated
February 12, 2019
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03370601
Brief Title
Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases
Acronym
STAMP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Not enough recruitment Lack of funding CR
Study Start Date
January 3, 2017 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
Keywords
crohn's disease, ulcerative colitis, infliximab, loss of response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Optimisation strategy
Arm Type
Other
Arm Description
increase of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks
Arm Title
Addition strategy
Arm Type
Other
Arm Description
same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
Infliximab 10mg/kg every 8 weeks
Intervention Type
Drug
Intervention Name(s)
Mercaptopurine
Other Intervention Name(s)
addition strategy with 6-mercaptopurine in second intention
Intervention Description
6-mercaptopurine 1 à 1,5 mg/kg
Intervention Type
Drug
Intervention Name(s)
Azathioprine
Other Intervention Name(s)
addition strategy with azathioprine in first intention
Intervention Description
Azathioprine 2 à 2.5mg/kg/j
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
Infliximab 5mg/kg every 8 weeks
Primary Outcome Measure Information:
Title
Number of patients in Clinical remission
Description
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.
Time Frame
At Week 52
Secondary Outcome Measure Information:
Title
Number of patients in deep remission
Description
clinical remission associated with endoscopic remission (CDEIS <3 for CD patients or Mayo score<2 for UC patients)
Time Frame
At Week 52
Title
Number of patient in remission and clinical response
Description
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.
Time Frame
At week 16
Title
infliximab blood concentration
Time Frame
Baseline, week 16 ad week 52
Title
infliximab antibodies concentration
Time Frame
Baseline, week 16 ad week 52
Title
economic criteria
Description
medical fees in each arm
Time Frame
At week 52
Title
number of patient with adverse effects and allergic reactions with infliximab
Time Frame
At week 52
Title
Inflammatory bowel disease questionnaire (score IBDQ)
Description
quality of life
Time Frame
Baseline and week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Pariente, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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