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

Inflammatory Bowel Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03370601
• Other study ID #: 2015_23
• Secondary ID: 2015-A00940-49
• Status: Terminated
• Phase: N/A
• Start date: January 3, 2017
• Est. completion date: January 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Drug:
• Infliximab
Infliximab 10mg/kg every 8 weeks
• Mercaptopurine
6-mercaptopurine 1 à 1,5 mg/kg
• Azathioprine
Azathioprine 2 à 2.5mg/kg/j
• Infliximab
Infliximab 5mg/kg every 8 weeks

Locations

Country	Name	City	State
France	CHRU, Hôpital Claude Huriez	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	infliximab blood concentration		Baseline, week 16 ad week 52
Secondary	infliximab antibodies concentration		Baseline, week 16 ad week 52
Secondary	economic criteria	medical fees in each arm	At week 52
Secondary	number of patient with adverse effects and allergic reactions with infliximab		At week 52
Secondary	Inflammatory bowel disease questionnaire (score IBDQ)	quality of life	Baseline and week 52