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).

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152425

Enrollment

392

Registered

2005-09-09

Start date

2004-02-29

Completion date

2005-05-31

Last updated

2013-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's disease, CDP870, CDAI, clinical response, remission, Certolizumab Pegol, Cimzia

Brief summary

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

Interventions

DRUGCertolizumab Pegol (CDP870)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Clinical response at Week 26, in the strata defined by CRP ≥ 10 mg/L.	—

Secondary

Measure	Time frame
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 7, 2026