Trial Outcomes & Findings for Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test) (NCT NCT00845663)
NCT ID: NCT00845663
Last Updated: 2011-08-31
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
98 participants
Primary outcome timeframe
After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12
Results posted on
2011-08-31
Participant Flow
In total 159 subjects have been screened. Participant Flow presents all subjects randomized. Intent-to-treat and Safety population are identical to randomized population.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
Baseline characteristics by cohort
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
38.78 years
STANDARD_DEVIATION 9.95 • n=5 Participants
|
33.18 years
STANDARD_DEVIATION 9.63 • n=7 Participants
|
35.98 years
STANDARD_DEVIATION 10.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
49 participants
n=5 Participants
|
49 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Body Height
|
168.64 cm
STANDARD_DEVIATION 9.47 • n=5 Participants
|
170.12 cm
STANDARD_DEVIATION 9.04 • n=7 Participants
|
169.38 cm
STANDARD_DEVIATION 9.24 • n=5 Participants
|
|
Body Mass Index
|
23.36 kilogram/square meter
STANDARD_DEVIATION 2.53 • n=5 Participants
|
22.93 kilogram/square meter
STANDARD_DEVIATION 2.43 • n=7 Participants
|
23.15 kilogram/square meter
STANDARD_DEVIATION 2.48 • n=5 Participants
|
|
Body Surface Area
|
1.759 Square meter
STANDARD_DEVIATION 0.171 • n=5 Participants
|
1.770 Square meter
STANDARD_DEVIATION 0.172 • n=7 Participants
|
1.765 Square meter
STANDARD_DEVIATION 0.171 • n=5 Participants
|
|
Body Weight
|
66.59 kilogram
STANDARD_DEVIATION 10.11 • n=5 Participants
|
66.58 kilogram
STANDARD_DEVIATION 10.23 • n=7 Participants
|
66.59 kilogram
STANDARD_DEVIATION 10.12 • n=5 Participants
|
PRIMARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Area Under the Plasma Drug Concentration-time Curve From Time 0 to Infinity (AUC)
|
1308 microgram *day/mL
Interval 731.0 to 2364.0
|
1326 microgram *day/mL
Interval 691.0 to 2708.0
|
PRIMARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Area Under the Plasma Drug Concentration-time Curve From Time 0 to the Last Quantifiable Point (AUC(0-t))
|
1269 microgram*day/mL
Interval 716.0 to 2293.0
|
1240 microgram*day/mL
Interval 592.0 to 2696.0
|
PRIMARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax)
|
61.6 microgram/mL
Interval 32.4 to 121.0
|
60.1 microgram/mL
Interval 29.1 to 105.0
|
SECONDARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
TLIN describes timepoint for start of elimination phase determined on the basis of a linear regression model of the log-transformed concentration data.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Time Point Where Log-linear Elimination Phase Begins (TLIN)
|
21.0 days
Full Range 9.05 • Interval 9.0 to 42.0
|
21.0 days
Full Range 8.89 • Interval 6.0 to 42.0
|
SECONDARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Lowest Quantifiable Concentration Time (LQCT)
|
56.0 days
Full Range 16.3 • Interval 28.0 to 84.0
|
84.0 days
Full Range 17.0 • Interval 28.0 to 84.0
|
SECONDARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Apparent Terminal Elimination Rate Constant (λz)
|
0.0732 1/day
Standard Deviation 0.0387
|
0.0639 1/day
Standard Deviation 0.0189
|
SECONDARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Apparent Terminal Elimination Half-life (t1/2)
|
10.9 days
Interval 2.57 to 21.3
|
11.7 days
Interval 5.99 to 24.1
|
SECONDARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Time Corresponding to Cmax (Tmax)
|
5.00 days
Interval 3.0 to 9.0
|
5.00 days
Interval 2.04 to 14.0
|
SECONDARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Apparent Total Body Clearance (CL/F)
|
306 mL/day
Interval 169.0 to 547.0
|
302 mL/day
Interval 148.0 to 579.0
|
SECONDARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Apparent Volume of Distribution (Vz/F)
|
4.58 L
Interval 1.39 to 13.0
|
4.92 L
Interval 2.07 to 10.9
|
SECONDARY outcome
Timeframe: After 12 and 24 hours, on day 3, 4, 5, 6, 7, 10, after week 2, 3, 4, 6, 8, 12Population: Per Protocol Population
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Number of Subjects With Anti-certolizumab Pegol Antibody Plasma Level >2.4 Units/mL
|
22 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection and 1 hour after injectionPopulation: Intent-to-treat population
Visual Analog Scale (VAS) ranges from 0 (no pain at all) to 100 mm (max. pain).
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
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
|
20.9 Units on a scale
Standard Deviation 15.6
|
|
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 4.0
|
1.1 Units on a scale
Standard Deviation 2.3
|
|
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
|
-19.8 Units on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Before and 24 hours post-dosePopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
Before - not at all
|
13 Participants
|
18 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
Before - a little
|
17 Participants
|
16 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
Before - moderately
|
17 Participants
|
14 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
Before - very
|
0 Participants
|
1 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
Before - extremely
|
1 Participants
|
0 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
24 hours post-dose - not at all
|
15 Participants
|
18 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
24 hours post-dose - a little
|
19 Participants
|
16 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
24 hours post-dose - moderately
|
14 Participants
|
14 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
24 hours post-dose - very
|
0 Participants
|
1 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Needles
24 hours post-dose - extremely
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Before and 24 hours post-dosePopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
Before - not at all
|
11 Participants
|
13 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
Before - a little
|
21 Participants
|
17 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
Before - moderately
|
16 Participants
|
19 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
Before - very
|
0 Participants
|
0 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
Before - extremely
|
1 Participants
|
0 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
24 hours post-dose - not at all
|
13 Participants
|
13 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
24 hours post-dose - a little
|
21 Participants
|
17 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
24 hours post-dose - moderately
|
14 Participants
|
19 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
24 hours post-dose - very
|
0 Participants
|
0 Participants
|
|
Injection Questionnaire Per Formulation and Per Time Point - Afraid of Having Injections
24 hours post-dose - extremely
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection, 1 h and 24 h after injectionPopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
Immediately after injection - not at all
|
11 Participants
|
7 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
Immediately after injection - a little
|
16 Participants
|
26 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
Immediately after injection - moderately
|
18 Participants
|
13 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
Immediately after injection - very
|
4 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
Immediately after injection - extremely
|
0 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
1 hour after injection - not at all
|
35 Participants
|
32 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
1 hour after injection - a little
|
10 Participants
|
14 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
1 hour after injection - moderately
|
2 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
1 hour after injection - very
|
1 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
1 hour after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
24 hours after injection - not at all
|
33 Participants
|
28 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
24 hours after injection - a little
|
9 Participants
|
16 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
24 hours after injection - moderately
|
5 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
24 hours after injection - very
|
1 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Pain
24 hours after injection - extremely
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection, 1 hour and 24 hours after injectionPopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
Immediately after injection - not at all
|
23 Participants
|
23 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
Immediately after injection - a little
|
12 Participants
|
13 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
Immediately after injection - moderately
|
6 Participants
|
11 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
Immediately after injection - very
|
7 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
Immediately after injection - extremely
|
1 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
1 hour after injection - not at all
|
42 Participants
|
41 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
1 hour after injection - a little
|
4 Participants
|
8 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
1 hour after injection - moderately
|
1 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
1 hour after injection - very
|
1 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
1 hour after injection - extremely
|
1 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
24 hours after injection - not at all
|
39 Participants
|
38 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
24 hours after injection - a little
|
5 Participants
|
9 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
24 hours after injection - moderately
|
2 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
24 hours after injection - very
|
2 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Burning Sensation
24 hours after injection - extremely
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection, 1 hour and 24 hours after injectionPopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
Immediately after injection - not at all
|
42 Participants
|
37 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
Immediately after injection - a little
|
6 Participants
|
11 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
Immediately after injection - moderately
|
1 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
Immediately after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
Immediately after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
1 hour after injection - not at all
|
47 Participants
|
49 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
1 hour after injection - a little
|
2 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
1 hour after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
1 hour after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
1 hour after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
24 hours after injection - not at all
|
46 Participants
|
46 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
24 hours after injection - a little
|
3 Participants
|
3 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
24 hours after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
24 hours after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Cold Sensation
24 hours after injection - extremely
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection, 1 hour and 24 hours after injectionPopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
Immediately after injection - not at all
|
46 Participants
|
44 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
Immediately after injection - a little
|
3 Participants
|
5 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
Immediately after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
Immediately after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
Immediately after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
1 hour after injection - not at all
|
46 Participants
|
47 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
1 hour after injection - a little
|
3 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
1 hour after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
1 hour after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
1 hour after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
24 hours after injection - not at all
|
47 Participants
|
46 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
24 hours after injection - a little
|
2 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
24 hours after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
24 hours after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Itching
24 hours after injection - extremely
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection, 1 hour and 24 hours after injectionPopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
Immediately after injection - not at all
|
24 Participants
|
39 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
Immediately after injection - a little
|
19 Participants
|
8 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
Immediately after injection - moderately
|
6 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
Immediately after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
Immediately after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
1 hour after injection - not at all
|
28 Participants
|
47 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
1 hour after injection - a little
|
19 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
1 hour after injection - moderately
|
2 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
1 hour after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
1 hour after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
24 hours after injection - not at all
|
39 Participants
|
46 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
24 hours after injection - a little
|
10 Participants
|
3 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
24 hours after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
24 hours after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Redness
24 hours after injection - extremely
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection, 1 hour and 24 hours after injectionPopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
Immediately after injection - not at all
|
37 Participants
|
34 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
Immediately after injection - a little
|
11 Participants
|
14 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
Immediately after injection - moderately
|
1 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
Immediately after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
Immediately after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
1 hour after injection - not at all
|
39 Participants
|
40 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
1 hour after injection - a little
|
10 Participants
|
7 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
1 hour after injection - moderately
|
0 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
1 hour after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
1 hour after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
24 hours after injection - not at all
|
40 Participants
|
37 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
24 hours after injection - a little
|
8 Participants
|
11 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
24 hours after injection - moderately
|
1 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
24 hours after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Swelling
24 hours after injection - extremely
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection, 1 hour and 24 hours after injectionPopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
Immediately after injection - not at all
|
46 Participants
|
47 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
Immediately after injection - a little
|
3 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
Immediately after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
Immediately after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
Immediately after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
1 hour after injection - not at all
|
49 Participants
|
47 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
1 hour after injection - a little
|
0 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
1 hour after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
1 hour after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
1 hour after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
24 hours after injection - not at all
|
45 Participants
|
46 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
24 hours after injection - a little
|
4 Participants
|
3 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
24 hours after injection - moderately
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
24 hours after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Bruising
24 hours after injection - extremely
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately after injection, 1 hour and 24 hours after injectionPopulation: Intent-to-treat population
Categorized answer ranges from not at all to extremely.
Outcome measures
| Measure |
Pre-filled Syringe
n=49 Participants
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
|
Auto-Injection Device
n=49 Participants
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
|
|---|---|---|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
24 hours after injection - not at all
|
38 Participants
|
38 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
Immediately after injection - not at all
|
37 Participants
|
34 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
Immediately after injection - a little
|
11 Participants
|
12 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
Immediately after injection - moderately
|
1 Participants
|
2 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
Immediately after injection - very
|
0 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
Immediately after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
1 hour after injection - not at all
|
38 Participants
|
34 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
1 hour after injection - a little
|
9 Participants
|
12 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
1 hour after injection - moderately
|
2 Participants
|
3 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
1 hour after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
1 hour after injection - extremely
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
24 hours after injection - a little
|
11 Participants
|
10 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
24 hours after injection - moderately
|
0 Participants
|
1 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
24 hours after injection - very
|
0 Participants
|
0 Participants
|
|
Injection Site Reaction Questionnaire Per Formulation and Per Time Point - Hardening
24 hours after injection - extremely
|
0 Participants
|
0 Participants
|
Adverse Events
Pre-filled Syringe
Serious events: 1 serious events
Other events: 30 other events
Deaths: 0 deaths
Auto-Injection Device
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pre-filled Syringe
n=49 participants at risk
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
|
Auto-Injection Device
n=49 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
2.0%
1/49 • Number of events 1
|
0.00%
0/49
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/49
|
2.0%
1/49 • Number of events 1
|
Other adverse events
| Measure |
Pre-filled Syringe
n=49 participants at risk
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
|
Auto-Injection Device
n=49 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.1%
3/49
|
4.1%
2/49
|
|
Gastrointestinal disorders
Nausea
|
4.1%
2/49
|
12.2%
6/49
|
|
General disorders
Asthenia
|
6.1%
3/49
|
2.0%
1/49
|
|
General disorders
Influenza like illness
|
0.00%
0/49
|
10.2%
5/49
|
|
Infections and infestations
Nasopharyngitis
|
20.4%
10/49
|
14.3%
7/49
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
3/49
|
2.0%
1/49
|
|
Nervous system disorders
Headache
|
44.9%
22/49
|
38.8%
19/49
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
8.2%
4/49
|
2.0%
1/49
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
6.1%
3/49
|
2.0%
1/49
|
Additional Information
UCB Clinical Trial Call Center
UCB Pharma
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER