Optimizing Cimzia in Crohn's Patients

Atlanta Gastroenterology Associates

Status and phase: Unknown; Phase 4

Conditions: Crohn's Disease

Treatments: Biological: certolizumab pegol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01024647

CMZ-2010

Details and patient eligibility

About

The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.

Full description

This open label study for patients with moderate to severe Crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (Cimzia). It is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. The following dosing options will be tested: 1) Re-induction (one supplemental dose of 400mg) 2) Dose splitting (200mgQ2W) and 3) Dose Escalation (400mg Q2W. The highest dose in the study, 400mg Q2W, has been used in a large phase III trial (WELCOME) without any new safety signals. Efficacy and safety measures will be monitored.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ileal and/or colonic Crohn's disease
• moderate to severe Crohn's disease

Exclusion criteria

• short bowel syndrome
• ostomy
• anti-TNF therapy within 4 weeks
• prior certolizumab therapy

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 4 patient groups

Loss of Reponse Reinduction Responders

Active Comparator group

Description:

Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks

Treatment:

Biological: certolizumab pegol

Biological: certolizumab pegol

Biological: certolizumab pegol

Biological: certolizumab pegol

Response loss Reinduction Non-Responders

Active Comparator group

Description:

Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks

Treatment:

Biological: certolizumab pegol

Biological: certolizumab pegol

Biological: certolizumab pegol

Biological: certolizumab pegol

Responders

Active Comparator group

Description:

Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks

Treatment:

Biological: certolizumab pegol

Biological: certolizumab pegol

Biological: certolizumab pegol

Biological: certolizumab pegol

Non-Responders

Active Comparator group

Description:

Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks

Treatment:

Biological: certolizumab pegol

Biological: certolizumab pegol

Biological: certolizumab pegol

Biological: certolizumab pegol