NCT01091220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

September 5, 2011

Status Verified

March 1, 2011

Enrollment Period

1 year

First QC Date

March 19, 2010

Last Update Submit

September 2, 2011

Conditions

Sperm Quality

Keywords

certolizumab pegolCimzia®healthy male volunteerssperm

Outcome Measures

Primary Outcomes (2)

  • Total sperm motility (%)

    baseline to 99 days

  • Sperm morphology (%)

    Baseline to 99 days

Secondary Outcomes (6)

  • Progressive motility (%)

    Baseline to 99 days

  • Non-progressive motility (%)

    Baseline to 99 days

  • Sperm vitality (%)

    Baseline to 99 days

  • Semen volume (mL)

    Baseline to 99 days

  • Sperm count (millions)

    Baseline to 99 days

  • +1 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0.9% saline

Biological: Placebo

Certolizumab pegol

EXPERIMENTAL

Certolizumab pegol 400 mg

Biological: Certolizumab pegol

Interventions

Certolizumab pegolBIOLOGICAL

400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously

Also known as: Cimzia®
Certolizumab pegol
PlaceboBIOLOGICAL

2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers with normal baseline semen quality parameters

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Liège, Belgium

Location

MeSH Terms

Interventions

Certolizumab Pegol

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2010

First Posted

March 23, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

September 5, 2011

Record last verified: 2011-03

Locations

BE(1)