Mucosal Healing Study in Crohn's Disease (CD) (MUSIC)

UCB

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Biological: Certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00297648

EudraCT Number 2005-003977-25 (Other Identifier)

C87043

Details and patient eligibility

About

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
• Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

Exclusion criteria

• Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
• History of tuberculosis or positive tests for tuberculosis at screening
• All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
• Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

CDP870 400 mg

Experimental group

Description:

Certolizumab pegol (CDP870) 400 mg

Treatment:

Biological: Certolizumab pegol