Advertisement

Topics

Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers

2014-08-27 03:15:04 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Conditions

Sperm Quality

Intervention

Certolizumab pegol, Placebo

Location

Liège
Belgium

Status

Recruiting

Source

UCB, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:04-0400

Clinical Trials [320 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...

Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis

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...

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...

PubMed Articles [8165 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 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...

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.

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...

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

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.

More From BioPortfolio on "Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
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...


Searches Linking to this Trial