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

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ClinicalTrials.gov Identifier: NCT03370601
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Drug: Infliximab Drug: Mercaptopurine Drug: Azathioprine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 28, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Addition strategy
same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine
Drug: Mercaptopurine
6-mercaptopurine 1 à 1,5 mg/kg
Other Name: addition strategy with 6-mercaptopurine in second intention

Drug: Azathioprine
Azathioprine 2 à 2.5mg/kg/j
Other Name: addition strategy with azathioprine in first intention

Drug: Infliximab
Infliximab 5mg/kg every 8 weeks




Primary Outcome Measures :
  1. Number of patients in Clinical remission [ Time Frame: 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 :
  1. Number of patients in deep remission [ Time Frame: At Week 52 ]
    clinical remission associated with endoscopic remission (CDEIS <3 for CD patients or Mayo score<2 for UC patients)

  2. Number of patient in remission and clinical response [ Time Frame: 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.


  3. infliximab blood concentration [ Time Frame: Baseline, week 16 ad week 52 ]
  4. infliximab antibodies concentration [ Time Frame: Baseline, week 16 ad week 52 ]
  5. economic criteria [ Time Frame: At week 52 ]
    medical fees in each arm

  6. number of patient with adverse effects and allergic reactions with infliximab [ Time Frame: At week 52 ]
  7. Inflammatory bowel disease questionnaire (score IBDQ) [ Time Frame: Baseline and week 52 ]
    quality of life



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370601


Contacts
Contact: Benjamin Pariente, MD + 33 3 20 44 53 21 benjamin.pariente@chru-lille.fr
Contact: Maria Nachury, MD + 33 20 44 47 14 maria.nachury@chru-lille.fr

Locations
France
CHRU, Hôpital Claude Huriez Recruiting
Lille, France
Principal Investigator: Benjamin Pariente, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Benjamin Pariente, MD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03370601     History of Changes
Other Study ID Numbers: 2015_23
2015-A00940-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 12, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
crohn's disease
ulcerative colitis
infliximab
loss of response

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Infliximab
Azathioprine
Immunosuppressive Agents
6-Mercaptopurine
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors