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Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

2010-07-15 17:00:00 | BioPortfolio

Summary

The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of certolizumab pegol (CZP) in subjects with active axial spondyloarthritis (axial SpA).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Spondolyarthropathies

Intervention

Certolizumab pegol, Certolizumab pegol, Placebo

Location

Birmingham
Alabama
United States

Status

Recruiting

Source

UCB, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

Clinical Trials [78 Associated Clinical Trials listed on BioPortfolio]

Optimizing Cimzia in Crohn's Patients

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 m...

Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease

This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blin...

Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease

This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.

Efficacy and Safety Study of Certolizumab Pegol (CZP) Versus Active Comparator and Placebo in Subjects With Plaque Psoriasis (PSO)

The purpose of this study is to investigate the efficacy and safety of two dose levels of certolizumab pegol compared to active comparator and placebo in adults with moderate to severe chr...

Pilot Study Evaluating the Efficacy of Certolizumab Pegol for Interstitial Cystitis

Randomized, double-blind, placebo controlled study evaluating the efficacy of certolizumab pegol in the treatment of interstitial cystitis/ bladder pain syndrome.

PubMed Articles [887 Associated PubMed Articles listed on BioPortfolio]

Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results Through 48 Weeks of a Phase 3, Multicenter, Randomized, Double-Blinded, Etanercept- and Placebo-Controlled Study (CIMPACT).

Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity.

Certolizumab Pegol for the Treatment of Patients with Moderate-to-Severe Chronic Plaque Psoriasis: Pooled Analysis of Week 16 Data from 3 Randomized Controlled Trials.

Certolizumab pegol, an Fc-free, PEGylated, anti-tumor necrosis factor (TNF) biologic, has demonstrated favorable results in three ongoing, phase 3, randomized, double-blinded, placebo-controlled trial...

Certolizumab pegol in the treatment of Takayasu arteritis.

Certolizumab pegol (CZP) is a PEGylated antigen-binding fragment-fragment of a humanized mAb neutralizing TNF. It lacks Fc-fragment and has a very low potential to cross the placenta. We aimed to repo...

Certolizumab Pegol for the Treatment of Chronic Plaque Psoriasis: Results through 48 Weeks from Two Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Studies (CIMPASI-1 and CIMPASI-2).

Certolizumab pegol, the only Fc-Free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements and suggested a positive risk-benefit balance in phase 2 studies in...

Treatment of Rheumatoid Arthritis with Certolizumab Pegol: Results from PROACTIVE, a Non-Interventional Study in the UK and Ireland.

The objective of this non-interventional study was to investigate the long-term safety and effectiveness of certolizumab pegol (CZP) in patients with rheumatoid arthritis (RA) in the UK and Ireland.

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.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

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