Evaluation of the Effects of Certolizumab Pegol on Semen... | NCT01091220

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

NCT01091220

Sponsor

UCB Pharma

Status

Completed

Last Update Posted

Sep 5, 2011Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Sperm Quality

Interventions

Certolizumab pegol
Placebo

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-015216-17	EudraCT Number

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Mar 19, 2010

First Submission Date that Met QC Criteria

Mar 22, 2010

First Posted Date

Mar 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 2, 2011

Last Update Posted Date

Sep 5, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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 400 mg dose of CZP, or matched placebo.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	0.9% saline	Biological: Placebo
Certolizumab pegol	Experimental	Certolizumab pegol 400 mg	Biological: Certolizumab pegol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Certolizumab pegol	Biological	400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously	Certolizumab pegol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total sperm motility (%)		baseline to 99 days
Sperm morphology (%)		Baseline to 99 days

Secondary Outcomes

Measure	Description	Time Frame
Progressive motility (%)		Baseline to 99 days
Non-progressive motility (%)		Baseline to 99 days
Sperm vitality (%)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male volunteers with normal baseline semen quality parameters

Exclusion Criteria:

Previous participation in studies involving TNF inhibitors
Prior treatment with biologic response modifiers within 5 half-lives
History of trauma or surgery to the pelvis/genital area
Tests positive for tuberculosis, HIV, Hepatitis B or C

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Liège			Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D000068582	Certolizumab Pegol

Ancestor Terms

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments

Browse Leaves

Not provided

Browse Branches

Not provided