Study to Test the Effect of CDP870 in the Treatment of Crohn's Disease Over 26 Weeks, Comparing CDP870 to a Dummy Drug (Placebo), Following 3 Doses of Active Drug (CDP870).

Crohn's Disease Clinical Trial

Official title:

A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Maintenance of Clinical Response to Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed 4-weekly From Weeks 8 to 24), in the Treatment of Patients With Active Crohn's Disease Who Have Responded to Open Induction Therapy (Dosed at Weeks 0, 2 and 4) With CDP870

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152425
• Other study ID #: C87032
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: September 6, 2013
• Start date: February 2004
• Est. completion date: May 2005

Study information

• Verified date: July 2010
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationCanada: Health CanadaDenmark: Danish Medicines AgencyGermany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyIreland: Irish Medicines BoardIsrael: Israeli Health Ministry Pharmaceutical AdministrationLithuania: State Medicine Control Agency - Ministry of HealthNew Zealand: Food Safety AuthorityNorway: Norwegian Medicines AgencyPoland: Ministry of HealthSerbia and Montenegro: Agency for Drugs and Medicinal DevicesSingapore: Health Sciences AuthoritySouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesUkraine: State Pharmacological Center - Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A 26 week maintenance study of CDP870 in Crohn's disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 392
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3)*. * Vienna Classification (1998)

• Active Crohn's disease (= 220 and = 450) scored over the 7 days prior to the first dose of study drug.

• Patients aged 18 years or above at screening.

Exclusion Criteria:

• Crohn's Disease Related

• Fistula abscess present at screening.

• Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.

• Short bowel syndrome.

• Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).

• Positive stool laboratory results for enteric pathogens.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Certolizumab Pegol (CDP870)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

References & Publications (7)

Coteur G, Feagan B, Keininger DL, Kosinski M. Evaluation of the meaningfulness of health-related quality of life improvements as assessed by the SF-36 and the EQ-5D VAS in patients with active Crohn's disease. Aliment Pharmacol Ther. 2009 May 1;29(9):1032 — View Citation

Feagan BG, Coteur G, Tan S, Keininger DL, Schreiber S. Clinically meaningful improvement in health-related quality of life in a randomized controlled trial of certolizumab pegol maintenance therapy for Crohn's disease. Am J Gastroenterol. 2009 Aug;104(8): — View Citation

Feagan BG, Hanauer SB, Coteur G, Schreiber S. Evaluation of a daily practice composite score for the assessment of Crohn's disease: the treatment impact of certolizumab pegol. Aliment Pharmacol Ther. 2011 May;33(10):1143-51. doi: 10.1111/j.1365-2036.2011. — View Citation

Feagan BG, Reilly MC, Gerlier L, Brabant Y, Brown M, Schreiber S. Clinical trial: the effects of certolizumab pegol therapy on work productivity in patients with moderate-to-severe Crohn's disease in the PRECiSE 2 study. Aliment Pharmacol Ther. 2010 Jun;3 — View Citation

Hanauer SB, Panes J, Colombel JF, Bloomfield R, Schreiber S, Sandborn WJ. Clinical trial: impact of prior infliximab therapy on the clinical response to certolizumab pegol maintenance therapy for Crohn's disease. Aliment Pharmacol Ther. 2010 Aug;32(3):384 — View Citation

Lichtenstein GR, Thomsen OØ, Schreiber S, Lawrance IC, Hanauer SB, Bloomfield R, Sandborn WJ; Precise 3 Study Investigators. Continuous therapy with certolizumab pegol maintains remission of patients with Crohn's disease for up to 18 months. Clin Gastroen — View Citation

Schreiber S, Khaliq-Kareemi M, Lawrance IC, Thomsen OØ, Hanauer SB, McColm J, Bloomfield R, Sandborn WJ; PRECISE 2 Study Investigators. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007 Jul 19;357(3):239-50. Erratum in: N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response at Week 26, in the strata defined by CRP = 10 mg/L.
Secondary	In population with CRP = 10 mg/L at baseline; Time to disease progression up to and including Week 26; Proportion of patients with clinical remission at Week 26; Proportion of patients with IBDQ response at Week 26; F-36 sub-scores and change from basel

External Links

•   Clinical Study Summary on UCB.com