Improving Treatment of Inflammatory Bowel Diseases Through Better Understanding Infliximab Drug and Antibody Levels

NCT01787786 | Withdrawn

• 1 other identifier: RP1207
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to develop a predictive model that will allow optimized dosing of infliximab for individual patients

Conditions

Crohn's Disease; Ulcerative Colitis

Keywords

Crohn's Disease; Ulcerative Colitis; Optimal Use of infliximab

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic Analysis of Infliximab in patients with moderate to severely active ulcerative colitis and Crohn's Disease

  The primary objective of this study is to define the PK profile of IFX in patients with CD and UC and to determine covariates influencing drug clearance.

  24 weeks

Secondary Outcomes (1)

• Quantification of relative strengths of individual determinants of infliximab pharmacokinetics

  24 weeks

Other Outcomes (1)

• Identification of patients at baseline that would benefit from receiving higher does of infliximab due to accelerated drug clearance

  24 weeks

Study Arms (1)

Irritable Bowel Disease

Infliximab administered according to current FDA and EMS approved doses and intervals.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

50 patients with Crohn's Disease and 50 patients with Ulcerative Colitis from 10 centres (Canada, United States, Netherlands and Spain).

You may qualify if:

• a diagnosis of CD or UC by usual criteria,
• moderate to severely active CD defined by a CDAI ≥ 220, with confirmed endoscopic activity (CDEIS ≥ 6) or moderate to severely active UC, defined by a Mayo Score ≥ 6, with a Mayo endoscopic subscore ≥ 2,
• a need for treatment with IFX for induction of remission as clinically indicated
• patients previously exposed to adalimumab and/or certolizumab who are naïve to infliximab will be allowed to participate.

You may not qualify if:

• perianal CD exclusively
• disease limited to the rectum in patients with UC (i.e., disease must extend ≥ 15 cm from the anal verge)
• patients with known antibodies to IFX (ADAs) at baseline
• a contraindication to infliximab therapy
• a contraindication to endoscopy
• an ostomy
• planned surgery
• evidence of severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological or renal disease at the discretion of the investigator,
• Pregnancy or breastfeeding,
• treatment with any investigational drug in the past 30 days, or 5 half lives (whichever is longer).

Sponsors & Collaborators

• University of Western Ontario, Canada: lead

Related Publications (5)

• Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516.

  PMID: 16339095 BACKGROUND

• Hanauer SB, Feagan BG, Lichtenstein GR, Mayer LF, Schreiber S, Colombel JF, Rachmilewitz D, Wolf DC, Olson A, Bao W, Rutgeerts P; ACCENT I Study Group. Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial. Lancet. 2002 May 4;359(9317):1541-9. doi: 10.1016/S0140-6736(02)08512-4.

  PMID: 12047962 BACKGROUND

• Reinisch W, Sandborn WJ, Rutgeerts P, Feagan BG, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Blank M, Lang Y, Johanns J, Colombel JF, Present D, Sands BE. Long-term infliximab maintenance therapy for ulcerative colitis: the ACT-1 and -2 extension studies. Inflamm Bowel Dis. 2012 Feb;18(2):201-11. doi: 10.1002/ibd.21697. Epub 2011 Apr 11.

  PMID: 21484965 BACKGROUND

• Gisbert JP, Panes J. Loss of response and requirement of infliximab dose intensification in Crohn's disease: a review. Am J Gastroenterol. 2009 Mar;104(3):760-7. doi: 10.1038/ajg.2008.88. Epub 2009 Jan 27.

  PMID: 19174781 BACKGROUND

• Maser EA, Villela R, Silverberg MS, Greenberg GR. Association of trough serum infliximab to clinical outcome after scheduled maintenance treatment for Crohn's disease. Clin Gastroenterol Hepatol. 2006 Oct;4(10):1248-54. doi: 10.1016/j.cgh.2006.06.025. Epub 2006 Aug 22.

  PMID: 16931170 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Brian Feagan, MD

  Robarts Clinical Trials - Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 11, 2013
• Primary Completion: March 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 3, 2015

Record last verified: 2015-12