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

A Phase III Multi-national, Multi-centre, Double-blind Placebo-controlled Parallel Group, 26 Week Study to Assess the Safety and Efficacy of the Humanised Anti-TNF PEG Conjugate, CDP870 400 mg sc, (Dosed at Weeks 0, 2, 4 Then 4-weekly to Week 24), in the Treatment of Patients With Active Crohn's Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00152490

Enrollment

604

Registered

2005-09-09

Start date

2003-12-31

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 study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

Detailed description

Receiving immunosuppressants (azathioprine/6-MP/methotrexate) at Week 0 or not. 604 patients will be enrolled with 1006 patients screened (to allow for 25% screen failures between screening and Week 0 and expected presentation at Screening of 60% of patients with CRP \< 10 mg/L and 40% of patients with CRP ≥ 10 mg/L).

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. * Male and female aged 18 years or above at screening. * Patients who meet all concomitant medication criteria in the protocol specified table. For all drugs being taken at screening, the patient should be able to remain on a stable dose throughout the duration of the study, although steroids may be tapered starting at Weeks 8 to 12.

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
In the population with CRP ≥ 10 mg/L at baseline	—
Clinical response at week 6	—
Clinical response at week 6 and week 26	—

Secondary

Measure	Time frame
In the population with CRP ≥ 10 mg/L at baseline - % patients in clinical remission at Week 6; % patients in clinical remission at both Week 6 and Week 26; % patients with IBDQ response at Week 6; % patients with IBDQ response at both Week 6 and Week 2	—

Outcome results

None listed

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