Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease

This study has been terminated.
(terminated due to poor enrollment)
Sponsor:
Collaborator:
Prometheus Laboratories
Information provided by (Responsible Party):
Shradha Agarwal, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01438151
First received: September 20, 2011
Last updated: March 4, 2014
Last verified: March 2014

September 20, 2011
March 4, 2014
December 2011
December 2013   (final data collection date for primary outcome measure)
Remicade Dose Escalation [ Time Frame: 2/16/12-3/22/13 ] [ Designated as safety issue: No ]
At visit 1 and 2, Remicade given at 5mg/kg. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Clinical responsiveness of Crohn's disease to infliximab as it relates to serum infliximab and ATI levels [ Time Frame: Prior to each infliximab infusion-every 6-8 weeks for a total of 8 infusion visits up to average of 1 year ] [ Designated as safety issue: No ]
Serum infliximab and ATI titers will be measured prior to patient's infliximab infusion over the course of 8 infusion visits (approximately 1 year). Treating physicians will be blinded to these results throughout the study. Results of these measurements will be correlated retrospectively to the patient's clinical response to infliximab.
Complete list of historical versions of study NCT01438151 on ClinicalTrials.gov Archive Site
Not Provided
Efficacy of dose escalation in nonresponders [ Time Frame: Prior to each infliximab infusion-every 6-8 weeks for a total of 8 infusion visits up to average of 1 year ] [ Designated as safety issue: No ]
Assessment of the patient's clinical response to infliximab will be done at each visit using the Harvey Bradshaw Index (HBI). Patients defined as nonresponders or with disease flare will have escalation in dose or dosing frequency according to a stepwise algorithm. Patients with a response (or in remission) will be maintained at the dose where response was achieved.
Not Provided
Not Provided
 
Understanding the Relationship Between Infliximab Levels to Clinical Response of Remicade in Crohn's Disease
Association of Serum Infliximab and Antibodies Toward Infliximab (ATI) to Clinical Outcomes in Crohn's Disease

The purpose of this study is to improve the investigators understanding of the relationship between Crohn's disease and blood levels of the drug infliximab (Remicade). The investigators want to determine whether measuring drug levels can be helpful in understanding how patients respond to this treatment.

The efficacy of infliximab to maintain remission in Crohn's disease has been confirmed by randomized, controlled trials, however the utility of serum infliximab and ATI titers is less clearly described in the clinical practice setting to manage dose and interval levels.

The primary objective of this study is to evaluate the clinical responsiveness of active (HBI >10) Crohn's disease to infliximab as it relates to serum infliximab levels. Though the assay for an infliximab level is commercially available, current dosing practices rely on the assessment of clinical data (laboratory data, symptoms, colonoscopy, etc). In order to understand this relationship, serum infliximab and ATI titers will be collected over the course of 8 (approximately 1 year) infusions. The results of these levels will be retrospectively correlated to the patient's clinical response to treatment.

The secondary objective is to identify predictors of poor response to infliximab by evaluating the efficacy of a dose escalation strategy in patients classified as primary or secondary non-responders.

Understanding the association of serum infliximab levels to disease response may be a useful objective tool to optimize and individualize dosing amount and frequency especially in patients with incomplete or loss of response to therapy.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Crohn's Disease
Drug: Remicade
The first potential for dose augmentation will be at infusion #3 (visit 1 and 2 patients will receive 5 mg/kg). Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Other Name: Dose escalation
Experimental: Remicade
Subjects will begin with receiving infliximab at 5 mg/kg for the first visits. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
Intervention: Drug: Remicade
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
11
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with active (HBI >10) refractory inflammatory and/or perianal fistulizing Crohn's disease who are prescribed infliximab as standard of care by their gastroenterologist.

Exclusion Criteria:

  • Pregnant women.
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01438151
11-0693
No
Shradha Agarwal, Mount Sinai School of Medicine
Shradha Agarwal
Prometheus Laboratories
Principal Investigator: Shradha Agarwal, MD Mount Sinai School of Medicine
Principal Investigator: Lloyd Mayer, MD Mount Sinai School of Medicine
Mount Sinai School of Medicine
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP