Study to Determine Relationship Between Serum Infliximab and Efficacy in Luminal Crohn's Disease Patients (X-Sectional)

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT00676988
First received: May 8, 2008
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

To assess the relationship between the change in Crohn's Disease Activity Index (CDAI) scores and trough serum infliximab concentration in subjects who are scheduled to receive infliximab infusions at an interval of 8 weeks.


Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Cross Sectional Study To Determine The Relationship Between Serum Infliximab Concentration And Efficacy In Patients With Luminal Crohn's Disease

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Biospecimen Retention:   Samples Without DNA

Serum infliximab concentrations and CRP levels.


Enrollment: 327
Study Start Date: May 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
Subjects with Luminal Crohn's Disease receiving infliximab

Detailed Description:

This cross sectional study will evaluate a sample of 360 subjects with luminal Crohn's disease who are receiving infliximab in 15-20 Canadian infusion centres. The sample will be stratified by disease activity [mild = CDAI <150, moderate/severe = CDAI ≥150] and whether or not subjects are on concomitant immunosuppressive therapy. Thus 4 strata will be created consisting of 90 subjects each. Consent will be obtained prior to or at Visit 1, subjects will retrospectively complete a CDAI diary card for the preceding 7 days and blood work will be drawn prior to infliximab infusion. Four weeks thereafter at Visit 2, subjects will provide an additional blood sample to measure serum infliximab concentrations and CRP levels. Between Visits 1 and 3, subjects will complete daily CDAI diary entries. Visit 3 will take place at the next scheduled infusion, 8 weeks after Visit 1 (+/- 7 days ).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with Luminal Crohn's disease receiving infliximab at Canadian Infusion Centres

Criteria

Inclusion Criteria:

  • Adult subjects (18 years of age or older at time of consent)
  • Confirmed diagnosis of inflammatory luminal Crohn's Disease
  • Receive infliximab therapy and have received a minimum of 5 consecutive infusions at prescribed intervals (minimum of 24 weeks and maximum of 156 weeks on infliximab therapy)
  • Plan to receive the next 2 infliximab infusions at 8-weekly intervals (+/- 7 days)
  • Able to provide written consent

Exclusion Criteria:

  • Active draining fistulizing Crohn's Disease
  • Presence of an ostomy
  • Diagnosis of ulcerative colitis
  • Infliximab dose of >5mg/kg
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676988

Locations
Canada, Ontario
MedEmerg Infusion Clinics
Mississauga, Ontario, Canada, L5N 2W3
Canada, Quebec
CIM - Centre d'Intervention Medicales Inc.
Pointe-Claire, Quebec, Canada, H9R 4S2
Sponsors and Collaborators
University of Western Ontario, Canada
Schering-Plough
Investigators
Principal Investigator: Brian G Feagan, MD Director Clinical Trials
Principal Investigator: Gordon R Greenberg, MD co-principal investigator
  More Information

No publications provided by University of Western Ontario, Canada

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT00676988     History of Changes
Other Study ID Numbers: RP0701
Study First Received: May 8, 2008
Last Updated: June 13, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Western Ontario, Canada:
Luminal Crohn's Disease
Infliximab

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014