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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091220
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : September 5, 2011
Information provided by (Responsible Party):
UCB Pharma

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.

Condition or disease Intervention/treatment Phase
Sperm Quality Biological: Certolizumab pegol Biological: Placebo Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Randomized, Single-center, Double-blind, Placebo-controlled Study to Explore the Effect of a Single Dose of Certolizumab Pegol 400 mg on Semen Quality in Healthy Male Volunteers
Study Start Date : March 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
0.9% saline
Biological: Placebo
2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously
Experimental: Certolizumab pegol
Certolizumab pegol 400 mg
Biological: Certolizumab pegol
400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously
Other Name: Cimzia®

Primary Outcome Measures :
  1. Total sperm motility (%) [ Time Frame: baseline to 99 days ]
  2. Sperm morphology (%) [ Time Frame: Baseline to 99 days ]

Secondary Outcome Measures :
  1. Progressive motility (%) [ Time Frame: Baseline to 99 days ]
  2. Non-progressive motility (%) [ Time Frame: Baseline to 99 days ]
  3. Sperm vitality (%) [ Time Frame: Baseline to 99 days ]
  4. Semen volume (mL) [ Time Frame: Baseline to 99 days ]
  5. Sperm count (millions) [ Time Frame: Baseline to 99 days ]
  6. Sperm concentration (millions/mL) [ Time Frame: Baseline to 99 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091220

Liège, Belgium
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Responsible Party: UCB Pharma Identifier: NCT01091220     History of Changes
Other Study ID Numbers: CR0001
2009-015216-17 ( EudraCT Number )
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: September 5, 2011
Last Verified: March 2011

Keywords provided by UCB Pharma:
certolizumab pegol
healthy male volunteers

Additional relevant MeSH terms:
Certolizumab Pegol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents