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Optimizing Cimzia in Crohn's Patients

2014-08-27 03:17:33 | BioPortfolio

Summary

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.

Description

This open label 26 week clinical trial will evaluate treatment options in patients with moderate to severe Crohn's disease who have had insufficient initial response or who have lost response to certolizumab pegol (Cimzia). 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.

Study Design

Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Crohn's Disease

Intervention

certolizumab pegol, certolizumab pegol, certolizumab pegol, certolizumab pegol

Location

Atlanta Gastroenterology Associates
Atlanta
Georgia
United States
30342

Status

Not yet recruiting

Source

Atlanta Gastroenterology Associates

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:33-0400

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PubMed Articles [14 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

A polyethylene-glycolated Fab' fragment of TUMOR NECROSIS FACTOR antibody that binds specifically to TNF-ALPHA and neutralises it in a dose-dependent manner. It also inhibits the production of lipopolysaccharide-induced TNF-ALPHA and IL-1 BETA and is used to treat RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.

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