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)

UCB Pharma604 enrolled

Overview

A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

604

Conditions

Crohn's Disease

Interventions

Certolizumab Pegol (CDP870)DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

In the population with CRP ≥ 10 mg/L at baseline

Clinical response at week 6

Clinical response at week 6 and week 26

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.