Healthy
Conditions
Keywords
certolizumab pegol, Cimzia, bioequivalence, Comparison Bioequivalence Study
Brief 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).
Interventions
DRUGCertolizumab pegol
Auto-injection device (test) containing 1 mL of certolizumab pegol liquid formulation, 200 mg/mL; 2 injections
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Immediately after injection and 1 hour after injection | Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain). |
| Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before and 24 hours post-dose | Categorized answer ranges from not at all to extremely. |
| Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before and 24 hours post-dose | Categorized answer ranges from not at all to extremely. |
| Time Point Where Log-linear Elimination Phase Begins (TLIN) | After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12 | TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data. |
| Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection, 1 hour and 24 hours after injection | Categorized answer ranges from not at all to extremely. |
| Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection, 1 hour and 24 hours after injection | Categorized answer ranges from not at all to extremely. |
| Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection, 1 hour and 24 hours after injection | Categorized answer ranges from not at all to extremely. |
| Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection, 1 hour and 24 hours after injection | Categorized answer ranges from not at all to extremely. |
| Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection, 1 hour and 24 hours after injection | Categorized answer ranges from not at all to extremely. |
| Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection, 1 hour and 24 hours after injection | Categorized answer ranges from not at all to extremely. |
| Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection, 1 hour and 24 hours after injection | Categorized answer ranges from not at all to extremely. |
| Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection, 1 h and 24 h after injection | Categorized answer ranges from not at all to extremely. |
| Lowest Quantifiable Concentration Time (LQCT) | 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 | — |
Countries
France
Participant flow
Recruitment details
In total 159 subjects have been screened. Participant Flow presents all subjects randomized. Intent-to-treat and Safety population are identical to randomized population.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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 | 49 |
| Total | 98 |
Baseline characteristics
| Characteristic | Pre-filled Syringe | Auto-Injection Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 49 Participants | 98 Participants |
| Age Continuous | 38.78 years STANDARD_DEVIATION 9.95 | 33.18 years STANDARD_DEVIATION 9.63 | 35.98 years STANDARD_DEVIATION 10.14 |
| Body Height | 168.64 cm STANDARD_DEVIATION 9.47 | 170.12 cm STANDARD_DEVIATION 9.04 | 169.38 cm STANDARD_DEVIATION 9.24 |
| Body Mass Index | 23.36 kilogram/square meter STANDARD_DEVIATION 2.53 | 22.93 kilogram/square meter STANDARD_DEVIATION 2.43 | 23.15 kilogram/square meter STANDARD_DEVIATION 2.48 |
| Body Surface Area | 1.759 Square meter STANDARD_DEVIATION 0.171 | 1.770 Square meter STANDARD_DEVIATION 0.172 | 1.765 Square meter STANDARD_DEVIATION 0.171 |
| Body Weight | 66.59 kilogram STANDARD_DEVIATION 10.11 | 66.58 kilogram STANDARD_DEVIATION 10.23 | 66.59 kilogram STANDARD_DEVIATION 10.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 48 Participants | 49 Participants | 97 Participants |
| Region of Enrollment France | 49 participants | 49 participants | 98 participants |
| Sex: Female, Male Female | 25 Participants | 28 Participants | 53 Participants |
| Sex: Female, Male Male | 24 Participants | 21 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 49 | 31 / 49 |
| serious Total, serious adverse events | 1 / 49 | 1 / 49 |
Outcome results
Primary
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
Population: Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pre-filled Syringe | Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC) | 1308 microgram *day/mL |
| Auto-Injection Device | Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC) | 1326 microgram *day/mL |
Comparison: Bioequivalence testing by using the 90% Confidence Interval90% CI: [92.84, 110.58]ANOVA
Primary
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
Population: Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pre-filled Syringe | Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t)) | 1269 microgram*day/mL |
| Auto-Injection Device | Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t)) | 1240 microgram*day/mL |
Comparison: Bioequivalence testing by using the 90% Confidence Interval90% CI: [89.06, 107.19]ANOVA
Primary
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
Population: Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pre-filled Syringe | Maximum Plasma Concentration (Cmax) | 61.6 microgram/mL |
| Auto-Injection Device | Maximum Plasma Concentration (Cmax) | 60.1 microgram/mL |
Comparison: Bioequivalence testing by using the 90% Confidence Interval90% CI: [87.33, 108.94]ANOVA
Secondary
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
Population: Per Protocol Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-filled Syringe | Apparent Terminal Elimination Half-life (t1/2) | 10.9 days |
| Auto-Injection Device | Apparent Terminal Elimination Half-life (t1/2) | 11.7 days |
Secondary
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
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-filled Syringe | Apparent Terminal Elimination Rate Constant (λz) | 0.0732 1/day | Standard Deviation 0.0387 |
| Auto-Injection Device | Apparent Terminal Elimination Rate Constant (λz) | 0.0639 1/day | Standard Deviation 0.0189 |
Secondary
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
Population: Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pre-filled Syringe | Apparent Total Body Clearance (CL/F) | 306 mL/day |
| Auto-Injection Device | Apparent Total Body Clearance (CL/F) | 302 mL/day |
Secondary
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
Population: Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Pre-filled Syringe | Apparent Volume of Distribution (Vz/F) | 4.58 L |
| Auto-Injection Device | Apparent Volume of Distribution (Vz/F) | 4.92 L |
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).
Time frame: Immediately after injection and 1 hour after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pre-filled Syringe | 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 | Immediately after injection | 28.9 Units on a scale | Standard Deviation 22.8 |
| Pre-filled Syringe | 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 | 1 hour after injection | 2.3 Units on a scale | Standard Deviation 4 |
| Pre-filled Syringe | 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 | Change over time (1 hour after injection) | -26.6 Units on a scale | Standard Deviation 22.8 |
| Auto-Injection Device | 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 | Immediately after injection | 20.9 Units on a scale | Standard Deviation 15.6 |
| Auto-Injection Device | 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 | 1 hour after injection | 1.1 Units on a scale | Standard Deviation 2.3 |
| Auto-Injection Device | 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 | Change over time (1 hour after injection) | -19.8 Units on a scale | Standard Deviation 15.6 |
Secondary
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
Categorized answer ranges from not at all to extremely.
Time frame: Before and 24 hours post-dose
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - not at all | 11 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - a little | 21 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - moderately | 16 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - very | 0 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - extremely | 1 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - not at all | 13 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - a little | 21 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - moderately | 14 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - very | 0 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - extremely | 1 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - moderately | 19 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - not at all | 13 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - not at all | 13 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - a little | 17 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - extremely | 0 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - moderately | 19 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - a little | 17 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - very | 0 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | 24 hours post-dose - very | 0 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections | Before - extremely | 0 Participants |
Secondary
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
Categorized answer ranges from not at all to extremely.
Time frame: Before and 24 hours post-dose
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - not at all | 13 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - a little | 17 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - moderately | 17 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - very | 0 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - extremely | 1 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - not at all | 15 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - a little | 19 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - moderately | 14 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - very | 0 Participants |
| Pre-filled Syringe | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - extremely | 1 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - moderately | 14 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - not at all | 18 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - not at all | 18 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - a little | 16 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - extremely | 0 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - moderately | 14 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - a little | 16 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - very | 1 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | 24 hours post-dose - very | 1 Participants |
| Auto-Injection Device | Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles | Before - extremely | 0 Participants |
Secondary
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
Categorized answer ranges from not at all to extremely.
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - a little | 3 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - not at all | 49 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - not at all | 45 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - a little | 4 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - a little | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - not at all | 46 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - not at all | 47 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - a little | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | Immediately after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - not at all | 47 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - a little | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 1 hour after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - not at all | 46 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - a little | 3 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising | 24 hours after injection - very | 0 Participants |
Secondary
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
Categorized answer ranges from not at all to extremely.
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - extremely | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - very | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - a little | 12 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - extremely | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - not at all | 42 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - not at all | 39 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - very | 7 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - a little | 5 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - a little | 4 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - moderately | 2 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - moderately | 6 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - very | 2 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - moderately | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - extremely | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - not at all | 23 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - not at all | 23 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - a little | 13 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - moderately | 11 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - very | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | Immediately after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - not at all | 41 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - a little | 8 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 1 hour after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - not at all | 38 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - a little | 9 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - moderately | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation | 24 hours after injection - very | 0 Participants |
Secondary
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
Categorized answer ranges from not at all to extremely.
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - a little | 6 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - not at all | 47 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - not at all | 46 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - a little | 3 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - a little | 2 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - moderately | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - not at all | 42 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - not at all | 37 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - a little | 11 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - moderately | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | Immediately after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - not at all | 49 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - a little | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 1 hour after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - not at all | 46 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - a little | 3 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation | 24 hours after injection - very | 0 Participants |
Secondary
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
Categorized answer ranges from not at all to extremely.
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - a little | 11 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - not at all | 38 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - not at all | 38 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - a little | 11 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - a little | 9 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - moderately | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - moderately | 2 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - not at all | 37 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - not at all | 34 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - a little | 12 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - moderately | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - very | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | Immediately after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - not at all | 34 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - a little | 12 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - moderately | 3 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 1 hour after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - not at all | 38 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - a little | 10 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - moderately | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening | 24 hours after injection - very | 0 Participants |
Secondary
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
Categorized answer ranges from not at all to extremely.
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - a little | 3 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - not at all | 46 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - not at all | 47 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - a little | 2 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - a little | 3 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - not at all | 46 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - not at all | 44 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - a little | 5 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | Immediately after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - not at all | 47 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - a little | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 1 hour after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - not at all | 46 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - a little | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching | 24 hours after injection - very | 0 Participants |
Secondary
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
Categorized answer ranges from not at all to extremely.
Time frame: Immediately after injection, 1 h and 24 h after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - very | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - a little | 16 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - not at all | 35 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - not at all | 33 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - very | 4 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - a little | 9 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - a little | 10 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - moderately | 5 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - moderately | 18 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - very | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - moderately | 2 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - extremely | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - not at all | 11 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - not at all | 7 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - a little | 26 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - moderately | 13 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - very | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | Immediately after injection - extremely | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - not at all | 32 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - a little | 14 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - moderately | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - very | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 1 hour after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - not at all | 28 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - a little | 16 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - moderately | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain | 24 hours after injection - very | 2 Participants |
Secondary
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
Categorized answer ranges from not at all to extremely.
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - a little | 19 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - not at all | 28 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - not at all | 39 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - a little | 10 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - a little | 19 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - moderately | 6 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - moderately | 2 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - not at all | 24 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - not at all | 39 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - a little | 8 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - moderately | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | Immediately after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - not at all | 47 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - a little | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 1 hour after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - not at all | 46 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - a little | 3 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - moderately | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness | 24 hours after injection - very | 0 Participants |
Secondary
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
Categorized answer ranges from not at all to extremely.
Time frame: Immediately after injection, 1 hour and 24 hours after injection
Population: Intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - a little | 11 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - not at all | 39 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - not at all | 40 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - a little | 8 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - a little | 10 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - moderately | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - moderately | 1 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - very | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - moderately | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - extremely | 0 Participants |
| Pre-filled Syringe | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - not at all | 37 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - not at all | 34 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - a little | 14 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - moderately | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | Immediately after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - not at all | 40 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - a little | 7 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - moderately | 2 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - very | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 1 hour after injection - extremely | 0 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - not at all | 37 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - a little | 11 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - moderately | 1 Participants |
| Auto-Injection Device | Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling | 24 hours after injection - very | 0 Participants |
Secondary
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
Population: Per Protocol Population
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Pre-filled Syringe | Lowest Quantifiable Concentration Time (LQCT) | 56.0 days | Full Range 16.3 |
| Auto-Injection Device | Lowest Quantifiable Concentration Time (LQCT) | 84.0 days | Full Range 17 |
Secondary
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
Population: Per Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pre-filled Syringe | Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL | 22 Participants |
| Auto-Injection Device | Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL | 15 Participants |
Secondary
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
Population: Per Protocol Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-filled Syringe | Time Corresponding to Cmax (Tmax) | 5.00 days |
| Auto-Injection Device | Time Corresponding to Cmax (Tmax) | 5.00 days |
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.
Time frame: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Population: Per Protocol Population
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Pre-filled Syringe | Time Point Where Log-linear Elimination Phase Begins (TLIN) | 21.0 days | Full Range 9.05 |
| Auto-Injection Device | Time Point Where Log-linear Elimination Phase Begins (TLIN) | 21.0 days | Full Range 8.89 |