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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-filled Syringe | Active Comparator | pre-filled syringe (reference) |
|
| Auto-injection Device | Experimental | Auto-injection device (test) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Certolizumab pegol | Drug | Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC) | 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)) | 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) | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes | France |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
Not provided
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In total 159 subjects have been screened. Participant Flow presents all subjects randomized. Intent-to-treat and Safety population are identical to randomized population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-filled Syringe | Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given |
| FG001 | Auto-Injection Device | Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-filled Syringe | Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given |
| BG001 | Auto-Injection Device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC) | Per Protocol Population | Posted | Geometric Mean | Full Range | microgram *day/mL | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-filled Syringe | Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
Not provided
| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
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| Certolizumab pegol | Drug | Pre-filled syringe (reference) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections |
|
|
| 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) | 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) | 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) | 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) | 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) | 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 | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Immediately after injection, 1 hour and 24 hours after injection |
Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Height | Mean | Standard Deviation | cm |
|
| Body Mass Index | Mean | Standard Deviation | kilogram/square meter |
|
| Body Surface Area | Mean | Standard Deviation | Square meter |
|
| Body Weight | Mean | Standard Deviation | kilogram |
|
|
|
|
| Primary | Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t)) | Per Protocol Population | Posted | Geometric Mean | Full Range | microgram*day/mL | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) | Per Protocol Population | Posted | Geometric Mean | Full Range | microgram/mL | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
|
| Secondary | 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. | Per Protocol Population | Posted | Median | Full Range | days | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
| Secondary | Lowest Quantifiable Concentration Time (LQCT) | Per Protocol Population | Posted | Median | Full Range | days | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
| Secondary | Apparent Terminal Elimination Rate Constant (λz) | Per Protocol Population | Posted | Mean | Standard Deviation | 1/day | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
| Secondary | Apparent Terminal Elimination Half-life (t1/2) | Per Protocol Population | Posted | Median | Full Range | days | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
| Secondary | Time Corresponding to Cmax (Tmax) | Per Protocol Population | Posted | Median | Full Range | days | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
| Secondary | Apparent Total Body Clearance (CL/F) | Per Protocol Population | Posted | Geometric Mean | Full Range | mL/day | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) | Per Protocol Population | Posted | Geometric Mean | Full Range | L | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
| Secondary | Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL | Per Protocol Population | Posted | Number | Participants | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 |
|
|
|
| Secondary | 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). | Intent-to-treat population | Posted | Mean | Standard Deviation | Units on a scale | Immediately after injection and 1 hour after injection |
|
|
|
| Secondary | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Before and 24 hours post-dose |
|
|
|
| Secondary | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Before and 24 hours post-dose |
|
|
|
| Secondary | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Immediately after injection, 1 h and 24 h after injection |
|
|
|
| Secondary | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Immediately after injection, 1 hour and 24 hours after injection |
|
|
|
| Secondary | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Immediately after injection, 1 hour and 24 hours after injection |
|
|
|
| Secondary | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Immediately after injection, 1 hour and 24 hours after injection |
|
|
|
| Secondary | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Immediately after injection, 1 hour and 24 hours after injection |
|
|
|
| Secondary | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Immediately after injection, 1 hour and 24 hours after injection |
|
|
|
| Secondary | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Immediately after injection, 1 hour and 24 hours after injection |
|
|
|
| Secondary | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Categorized answer ranges from not at all to extremely. | Intent-to-treat population | Posted | Number | Participants | Immediately after injection, 1 hour and 24 hours after injection |
|
|
|
| 1 |
| 49 |
| 30 |
| 49 |
| EG001 | Auto-Injection Device | Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given | 1 | 49 | 31 | 49 |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 9.0 | Non-systematic Assessment |
|
| Abortion induced | Surgical and medical procedures | MedDRA 9.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 9.0 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
|
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
| D007128 |
| Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Change over time (1 hour after injection) |
|
| Before - moderately |
|
| Before - very |
|
| Before - extremely |
|
| 24 hours post-dose - not at all |
|
| 24 hours post-dose - a little |
|
| 24 hours post-dose - moderately |
|
| 24 hours post-dose - very |
|
| 24 hours post-dose - extremely |
|
| Before - moderately |
|
| Before - very |
|
| Before - extremely |
|
| 24 hours post-dose - not at all |
|
| 24 hours post-dose - a little |
|
| 24 hours post-dose - moderately |
|
| 24 hours post-dose - very |
|
| 24 hours post-dose - extremely |
|
| Immediately after injection - moderately |
|
| Immediately after injection - very |
|
| Immediately after injection - extremely |
|
| 1 hour after injection - not at all |
|
| 1 hour after injection - a little |
|
| 1 hour after injection - moderately |
|
| 1 hour after injection - very |
|
| 1 hour after injection - extremely |
|
| 24 hours after injection - not at all |
|
| 24 hours after injection - a little |
|
| 24 hours after injection - moderately |
|
| 24 hours after injection - very |
|
| 24 hours after injection - extremely |
|
| Immediately after injection - moderately |
|
| Immediately after injection - very |
|
| Immediately after injection - extremely |
|
| 1 hour after injection - not at all |
|
| 1 hour after injection - a little |
|
| 1 hour after injection - moderately |
|
| 1 hour after injection - very |
|
| 1 hour after injection - extremely |
|
| 24 hours after injection - not at all |
|
| 24 hours after injection - a little |
|
| 24 hours after injection - moderately |
|
| 24 hours after injection - very |
|
| 24 hours after injection - extremely |
|
| Immediately after injection - moderately |
|
| Immediately after injection - very |
|
| Immediately after injection - extremely |
|
| 1 hour after injection - not at all |
|
| 1 hour after injection - a little |
|
| 1 hour after injection - moderately |
|
| 1 hour after injection - very |
|
| 1 hour after injection - extremely |
|
| 24 hours after injection - not at all |
|
| 24 hours after injection - a little |
|
| 24 hours after injection - moderately |
|
| 24 hours after injection - very |
|
| 24 hours after injection - extremely |
|
| Immediately after injection - moderately |
|
| Immediately after injection - very |
|
| Immediately after injection - extremely |
|
| 1 hour after injection - not at all |
|
| 1 hour after injection - a little |
|
| 1 hour after injection - moderately |
|
| 1 hour after injection - very |
|
| 1 hour after injection - extremely |
|
| 24 hours after injection - not at all |
|
| 24 hours after injection - a little |
|
| 24 hours after injection - moderately |
|
| 24 hours after injection - very |
|
| 24 hours after injection - extremely |
|
| Immediately after injection - moderately |
|
| Immediately after injection - very |
|
| Immediately after injection - extremely |
|
| 1 hour after injection - not at all |
|
| 1 hour after injection - a little |
|
| 1 hour after injection - moderately |
|
| 1 hour after injection - very |
|
| 1 hour after injection - extremely |
|
| 24 hours after injection - not at all |
|
| 24 hours after injection - a little |
|
| 24 hours after injection - moderately |
|
| 24 hours after injection - very |
|
| 24 hours after injection - extremely |
|
| Immediately after injection - moderately |
|
| Immediately after injection - very |
|
| Immediately after injection - extremely |
|
| 1 hour after injection - not at all |
|
| 1 hour after injection - a little |
|
| 1 hour after injection - moderately |
|
| 1 hour after injection - very |
|
| 1 hour after injection - extremely |
|
| 24 hours after injection - not at all |
|
| 24 hours after injection - a little |
|
| 24 hours after injection - moderately |
|
| 24 hours after injection - very |
|
| 24 hours after injection - extremely |
|
| Immediately after injection - moderately |
|
| Immediately after injection - very |
|
| Immediately after injection - extremely |
|
| 1 hour after injection - not at all |
|
| 1 hour after injection - a little |
|
| 1 hour after injection - moderately |
|
| 1 hour after injection - very |
|
| 1 hour after injection - extremely |
|
| 24 hours after injection - not at all |
|
| 24 hours after injection - a little |
|
| 24 hours after injection - moderately |
|
| 24 hours after injection - very |
|
| 24 hours after injection - extremely |
|
| Immediately after injection - moderately |
|
| Immediately after injection - very |
|
| Immediately after injection - extremely |
|
| 1 hour after injection - not at all |
|
| 1 hour after injection - a little |
|
| 1 hour after injection - moderately |
|
| 1 hour after injection - very |
|
| 1 hour after injection - extremely |
|
| 24 hours after injection - not at all |
|
| 24 hours after injection - a little |
|
| 24 hours after injection - moderately |
|
| 24 hours after injection - very |
|
| 24 hours after injection - extremely |
|