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Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC)

Information source: University of Western Ontario, Canada
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcerative Colitis

Intervention: MTX 12.5 (Drug); MTX 25 (Drug); Adalimumab (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: University of Western Ontario, Canada

Official(s) and/or principal investigator(s):
Brian Feagan, MD, Principal Investigator, Affiliation: Robarts Research Institute - Western University

Summary

Assess the body's reaction to dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active ulcerative colitis.

Clinical Details

Official title: A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination With Methotrexate for the Treatment of Patients With Ulcerative Colitis

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Pharmacokinetic Analysis (PK) will measure antidrug antibodies (ADAs)and plasma concentrations of adalimumab and methotrexate.

Secondary outcome:

Clinical and Endoscopic Evaluation of the Efficacy of Combination Therapy

Identify covariates

Relationship between PK and efficacy

Detailed description: Assess the Pharmacokinetic dose-response relationship for the adalimumab/Methotrexate interaction in subjects with moderately to severely active UC.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or non-pregnant, non-lactating females. Females of child bearing potential

must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i. e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).

- Diagnosis of UC confirmed by established criteria, regardless of disease duration.

- Moderate to severely active UC, defined by a modified Mayo Score ≥6, with confirmed

endoscopic activity by central reader (Mayo endoscopic subscore ≥2).

- Require initiation with adalimumab for induction of remission.

- Ability of subject to swallow study drug capsules.

- Ability of subject to participate fully in all aspects of this clinical trial.

- Written informed consent must be obtained and documented.

Exclusion Criteria:

- Prior treatment with a TNF antagonist or biological therapy.

- Prior treatment with MTX.

- Disease limited to the rectum (proctitis).

- Documented presence of antibodies against adalimumab.

- Contraindication for anti-TNF or MTX therapy.

- Contraindication for endoscopy.

- Ostomy.

- Planned surgery.

Locations and Contacts

Additional Information

Related publications:

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. Erratum in: N Engl J Med. 2006 May 18;354(20):2200.

Rutgeerts P, Van Assche G, Sandborn WJ, Wolf DC, Geboes K, Colombel JF, Reinisch W; EXTEND Investigators, Kumar A, Lazar A, Camez A, Lomax KG, Pollack PF, D'Haens G. Adalimumab induces and maintains mucosal healing in patients with Crohn's disease: data from the EXTEND trial. Gastroenterology. 2012 May;142(5):1102-1111.e2. doi: 10.1053/j.gastro.2012.01.035. Epub 2012 Feb 8.

Reinisch W, Sandborn WJ, Hommes DW, D'Haens G, Hanauer S, Schreiber S, Panaccione R, Fedorak RN, Tighe MB, Huang B, Kampman W, Lazar A, Thakkar R. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut. 2011 Jun;60(6):780-7. doi: 10.1136/gut.2010.221127. Epub 2011 Jan 5.

Baert F, Noman M, Vermeire S, Van Assche G, D' Haens G, Carbonez A, Rutgeerts P. Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease. N Engl J Med. 2003 Feb 13;348(7):601-8.

Starting date: June 2013
Last updated: June 1, 2015

Page last updated: August 23, 2015

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