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The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on the quality of sperm obtained from healthy male volunteers.
CZP is a PEGylated humanized Fab' fragment with specificity for human tumor necrosis factor alpha (TNFα). Evidence suggests that modulation of TNFα signaling may affect male spermatogenesis. Therefore, this study will compare semen quality parameters before and after a single 400mg dose of CZP, or matched placebo.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Certolizumab pegol, Placebo
Published on BioPortfolio: 2014-08-27T03:15:04-0400
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...
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, 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...
This is a multi-centre, randomized, double-blind, dose response clinical study of CDP870 in patients with Crohn's disease.
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...
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 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...
We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava®, an electromechanical device (e-Device) for self-injecting the anti-tumor necros...
The quality of SEMEN, an indicator of male fertility, can be determined by semen volume, pH, sperm concentration (SPERM COUNT), total sperm number, sperm viability, sperm vigor (SPERM MOTILITY), normal sperm morphology, ACROSOME integrity, and the concentration of WHITE BLOOD CELLS.
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.
An assisted fertilization technique consisting of the microinjection of a single viable sperm into an extracted ovum. It is used principally to overcome low sperm count, low sperm motility, inability of sperm to penetrate the egg, or other conditions related to male infertility (INFERTILITY, MALE).
Interactive processes between the oocyte (OVUM) and the sperm (SPERMATOZOA) including sperm adhesion, ACROSOME REACTION, sperm penetration of the ZONA PELLUCIDA, and events leading to FERTILIZATION.
The structural and functional changes by which SPERMATOZOA become capable of oocyte FERTILIZATION. It normally requires exposing the sperm to the female genital tract for a period of time to bring about increased SPERM MOTILITY and the ACROSOME REACTION before fertilization in the FALLOPIAN TUBES can take place.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Cytokine Tumour Necrosis Factor (TNF)
TNF is a compound that is classified as a cytokine which plays a central role in the cellular mechanisms of apoptosis or cell death. However, there are a number of different kinds of TNF, just under twenty, but the family of molecules have very similar a...