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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.
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.
Allocation: Non-Randomized, Control: Dose Comparison, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
certolizumab pegol, certolizumab pegol, certolizumab pegol, certolizumab pegol
Atlanta Gastroenterology Associates
Not yet recruiting
Atlanta Gastroenterology Associates
Published on BioPortfolio: 2014-08-27T03:17:33-0400
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...
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 wit...
This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.
The primary objective of the study is to assess the safety of long term therapy with certolizumab pegol in those subjects participating in study C87085.
The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA pati...
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...
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.
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...
Efficacy and safety of certolizumab pegol in combination with methotrexate in methotrexate-inadequate responder Chinese patients with active rheumatoid arthritis: 24-week results from a randomised, double-blind, placebo-controlled phase 3 study.
To evaluate the efficacy and safety of certolizumab pegol (CZP) in combination with methotrexate (MTX) in Chinese patients with active rheumatoid arthritis (RA) and an inadequate response to MTX.
Qualitative methods such as semi-structured interviews and focus-groups are used to evaluate the applicability and relevance of device technologies in clinical practice, but when used alone, often lac...
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.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Crohn's Disease (CD)
Crohn’s disease (CD) is a long-term condition that causes inflammation of the lining of the digestive system. Inflammation can affect any part of the digestive system, from the mouth to the back passage, but most commonly occurs in the last s...