Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
NCT ID: NCT00845663
Last Updated: 2011-08-31
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
98 participants
INTERVENTIONAL
2007-10-31
2008-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-filled Syringe
pre-filled syringe (reference)
Certolizumab pegol
Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Auto-injection Device
Auto-injection device (test)
Certolizumab pegol
Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Certolizumab pegol
Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Certolizumab pegol
Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A Body mass Index (BMI) of 18 to 28 kg/m
* Good physical and mental health status determined on the basis of the medical history and a general clinical examination
* Electrocardiogram and clinical laboratory tests interpreted as "normal"
* QuantiFERON-TB test negative
* female subjects: medically accepted method of contraception
Exclusion Criteria
* administered vaccines and immunoglobulins in the month preceding the certolizumab pegol injection
* history of significant disease, allergies
* history of drug and/or alcohol abuse
* hepatic enzyme inducing drug within 2 months before study drug administration
* any drugs having influence of the immune response and antibiotic in the month preceding the inclusion
* known to be intolerant to PEG
* previously received certolizumab pegol
* previously received an antibody product within 5-half lives of the antibody or within 3 months of the start of the study
* history of tuberculosis
* have serum hepatitis or is carrier of the Hepatitis B surface antigen (HBs Ag), or Hepatitis C antibody or who is HIV positive
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rennes, , France
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
FDA Safety Alerts and Recalls
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C87045
Identifier Type: -
Identifier Source: org_study_id