HealthyPhase 1NCT00845663

Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)

A Phase 1 study testing Certolizumab pegol in people with Healthy, run by UCB Pharma at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Certolizumab pegol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 98 participants
Where: 1 siteFrance
Study dates: Oct 2007to Apr 2008
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age: 18-55 years.
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

Who cannot join

prohibited concomitant medication
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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

France1 site

Study site
Rennes

Other trials in France

About this study

Official title: Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.

Conditions: Healthy
Being tested: Certolizumab pegol
Keywords: certolizumab pegol, Cimzia, bioequivalence, Comparison Bioequivalence Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Certolizumab pegolDrug
Also called Cimzia®, CDP870, CZP
Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Certolizumab pegolDrug
Also called Cimzia®, CDP870, CZP
Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections

Study groups in NCT00845663
Study group	Role	What they receive
Pre-filled Syringe	Active comparator	pre-filled syringe (reference) Receives: Drug: Certolizumab pegol
Auto-injection Device	Experimental	Auto-injection device (test) Receives: Drug: Certolizumab pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Maximum Plasma Concentration (Cmax)
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

Secondary outcomes (19)

Time Point Where Log-linear Elimination Phase Begins (TLIN)
TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data.
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Lowest Quantifiable Concentration Time (LQCT)
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Apparent Terminal Elimination Rate Constant (λz)
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Apparent Terminal Elimination Half-life (t1/2)
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Time Corresponding to Cmax (Tmax)
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Apparent Total Body Clearance (CL/F)
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Apparent Volume of Distribution (Vz/F)
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL
Measured: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Injection Pain Assessment on a Visual Analog Scale (VAS) Per Formulation and Per Time Point as Well as Change From Baseline (=Immediately After Injection) at One Hour After Injection
Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain).
Measured: Immediately after injection and 1 hour after injection
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
Categorized answer ranges from not at all to extremely.
Measured: Before and 24 hours post-dose
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
Categorized answer ranges from not at all to extremely.
Measured: Before and 24 hours post-dose
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
Categorized answer ranges from not at all to extremely.
Measured: Immediately after injection, 1 h and 24 h after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
Categorized answer ranges from not at all to extremely.
Measured: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
Categorized answer ranges from not at all to extremely.
Measured: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
Categorized answer ranges from not at all to extremely.
Measured: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
Categorized answer ranges from not at all to extremely.
Measured: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
Categorized answer ranges from not at all to extremely.
Measured: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
Categorized answer ranges from not at all to extremely.
Measured: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
Categorized answer ranges from not at all to extremely.
Measured: Immediately after injection, 1 hour and 24 hours after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Apr 2008

First posted18 Feb 2009 (estimated)
Study startOct 2007
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00845663
Sponsor's protocol ID: C87045
Status last verified: Dec 2009
First submitted: 13 Feb 2009
Last updated: 31 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label, Randomized, Parallel Group, Single Dose, 2-way Comparison Bioequivalence Study of Certolizumab Pegol Solution Injected Either by a Pre-filled Syringe (Reference) or by an Auto-injection Device (Test) to Healthy Volunteers.
ClinicalTrials.gov ID: NCT00845663
Acronym / sponsor ID: C87045
Conditions: Healthy
Keywords: certolizumab pegol, Cimzia, bioequivalence, Comparison Bioequivalence Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 98 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 18 Feb 2009 (estimated)
Results: Posted 17 Nov 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pre-filled Syringe	Active comparator	Drug: Certolizumab pegolpre-filled syringe (reference)
Auto-injection Device	Experimental	Drug: Certolizumab pegolAuto-injection device (test)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Age: 18-55 years.
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

Key exclusion criteria (11 listed)

prohibited concomitant medication
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Certolizumab pegolAlso: Cimzia®, CDP870, CZPAuto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections	Drug	Auto-injection Device
Certolizumab pegolAlso: Cimzia®, CDP870, CZPPre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections	Drug	Pre-filled Syringe

Primary outcome

Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Maximum Plasma Concentration (Cmax)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12

19 secondary outcomes

Time Point Where Log-linear Elimination Phase Begins (TLIN)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Lowest Quantifiable Concentration Time (LQCT)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Apparent Terminal Elimination Rate Constant (λz)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Apparent Terminal Elimination Half-life (t1/2)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Time Corresponding to Cmax (Tmax)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Apparent Total Body Clearance (CL/F)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Apparent Volume of Distribution (Vz/F)
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Injection Pain Assessment on a Visual Analog Scale (VAS) Per Formulation and Per Time Point as Well as Change From Baseline (=Immediately After Injection) at One Hour After Injection
Time frame: Immediately after injection and 1 hour after injection
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
Time frame: Before and 24 hours post-dose
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
Time frame: Before and 24 hours post-dose
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
Time frame: Immediately after injection, 1 h and 24 h after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
Time frame: Immediately after injection, 1 hour and 24 hours after injection

Results and safety

Results posted to the registry on 17 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-filled Syringe	49	49
Auto-Injection Device	49	49

Primary outcome: Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)

Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12. Geometric mean (Full Range). Unit: microgram *day/mL

Measure	Pre-filled Syringe n = 49	Auto-Injection Device n = 49
Value	1308 (731 to 2364)	1326 (691 to 2708)

Pre-filled Syringe vs Auto-Injection Device: ratio of geometric LS Means (percent): 101.33 (90% CI 92.84 to 110.58), ANOVA

Population analysed: Per Protocol Population

Primary outcome: Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))

Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12. Geometric mean (Full Range). Unit: microgram*day/mL

Measure	Pre-filled Syringe n = 49	Auto-Injection Device n = 49
Value	1269 (716 to 2293)	1240 (592 to 2696)

Pre-filled Syringe vs Auto-Injection Device: ratio of geometric LS Means (percent): 97.70 (90% CI 89.06 to 107.19), ANOVA

Population analysed: Per Protocol Population

Primary outcome: Maximum Plasma Concentration (Cmax)

Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12. Geometric mean (Full Range). Unit: microgram/mL

Measure	Pre-filled Syringe n = 49	Auto-Injection Device n = 49
Value	61.6 (32.4 to 121.0)	60.1 (29.1 to 105.0)

Pre-filled Syringe vs Auto-Injection Device: ratio of geometric LS Means (percent): 97.54 (90% CI 87.33 to 108.94), ANOVA

Population analysed: Per Protocol Population

19 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-filled Syringe	1 of 49 (2%)	30 of 49 (61.2%)	Not reported
Auto-Injection Device	1 of 49 (2%)	31 of 49 (63.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Certolizumab pegol in people with Healthy, run by UCB Pharma at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC) (time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00845663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2011.