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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00676988
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : June 14, 2012
Information provided by (Responsible Party):
University of Western Ontario, Canada

Brief Summary:
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 or disease
Crohn's Disease

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 ).

Study Type : Observational
Actual Enrollment : 327 participants
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
Study Start Date : May 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Subjects with Luminal Crohn's Disease receiving infliximab

Biospecimen Retention:   Samples Without DNA
Serum infliximab concentrations and CRP levels.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with Luminal Crohn's disease receiving infliximab at Canadian Infusion Centres

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

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 identifier (NCT number): NCT00676988

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
Principal Investigator: Brian G Feagan, MD Director Clinical Trials
Principal Investigator: Gordon R Greenberg, MD co-principal investigator

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Western Ontario, Canada Identifier: NCT00676988     History of Changes
Other Study ID Numbers: RP0701
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers