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

U

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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