To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects

Sponsor
Celltrion (Industry)
Overall Status
Completed
CT.gov ID
NCT03970824
Collaborator
(none)
312
Enrollment
9
Locations
3
Arms
7.5
Actual Duration (Months)
34.7
Patients Per Site
4.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: CT-P17
  • Biological: US-licensed Humira
  • Biological: EU-approved Humira
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
312 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects
Actual Study Start Date :
May 31, 2019
Actual Primary Completion Date :
Nov 13, 2019
Actual Study Completion Date :
Jan 15, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: CT-P17

a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: CT-P17
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

Active Comparator: US-licensed Humira

a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: US-licensed Humira
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

Active Comparator: EU-approved Humira

a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Biological: EU-approved Humira
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

Outcome Measures

Primary Outcome Measures

  1. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) [up to Day 71]

    Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

  2. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) [up to Day 71]

    Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

  3. Maximum Serum Concentration (Cmax) [up to Day 71]

    Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

Secondary Outcome Measures

  1. Time to the Maximum Serum Concentration (Tmax) [up to Day 71]

    The secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

  2. Terminal Elimination Half-life (t1/2) [up to Day 71]

    The secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy subjects

  • BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth

Exclusion Criteria:
  • A medical history and/or condition that is considered significant

  • Clinically significant allergic reactions, hypersensitivity

  • History or current infection of hepatitis B virus (except for past resolved infection), hepatitis C virus, human immunodeficiency virus, or syphilis

  • Active or latent Tuberculosis

  • History of malignancy

  • Previous monoclonal antibody or fusion protein treatment, or current use of any biologic

  • Planning to be pregnant or father a child or donate sperm within 5 month after administration

  • Undergone treatment with an investigational drug or participated in another clinical trial within 90 days or 5 half-lives (whichever is longer)

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Chungbuk National University HospitalCheongju-siChungcheongbuk-doKorea, Republic of28644
2CHA Bundang Medical CenterSeongnam-siGyeonggi-doKorea, Republic of13520
3Seoul National University Bundang HospitalSeongnam-siGyeonggi-doKorea, Republic of13620
4Chonbuk National University HospitalJeonjuJeollabuk-doKorea, Republic of54907
5Inje University Busan Paik HospitalBusanKorea, Republic of47392
6Chungnam National University HospitalDaejeonKorea, Republic of35015
7Seoul National University HospitalSeoulKorea, Republic of03080
8Severance HospitalSeoulKorea, Republic of03722
9Asan Medical CenterSeoulKorea, Republic of05505

Sponsors and Collaborators

  • Celltrion

Investigators

  • Study Director: Sang Joon Lee, Celltrion, Inc.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Celltrion
ClinicalTrials.gov Identifier:
NCT03970824
Other Study ID Numbers:
  • CT-P17 1.1
First Posted:
Jun 3, 2019
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleCT-P17US-licensed HumiraEU-approved Humira
Arm/Group Descriptiona single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Period Title: Overall Study
STARTED103103106
COMPLETED101100102
NOT COMPLETED234

Baseline Characteristics

Arm/Group TitleCT-P17US-licensed HumiraEU-approved HumiraTotal
Arm/Group Descriptiona single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSTotal of all reporting groups
Overall Participants102102104308
Age (years) [Median (Full Range) ]
Median (Full Range) [years]
25.0
26.0
26.0
26.0
Sex: Female, Male (Count of Participants)
Female
15
14.7%
14
13.7%
15
14.4%
44
14.3%
Male
87
85.3%
88
86.3%
89
85.6%
264
85.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
0
0%
Not Hispanic or Latino
102
100%
102
100%
104
100%
308
100%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
102
100%
102
100%
104
100%
308
100%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
0
0%
0
0%
0
0%
0
0%
White
0
0%
0
0%
0
0%
0
0%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (Count of Participants)
South Korea
102
100%
102
100%
104
100%
308
100%

Outcome Measures

1. Primary Outcome
TitleArea Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
DescriptionPrimary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Time Frameup to Day 71

Outcome Measure Data

Analysis Population Description
Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab)
Arm/Group TitleCT-P17US-licensed HumiraEU-approved Humira
Arm/Group Descriptiona single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Measure Participants808689
Mean (Standard Deviation) [h•μg/mL]
2656.5
(1150.16)
2469.7
(917.47)
2690.6
(943.76)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT-P17, US-licensed Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value105.79
Confidence Interval (2-Sided) 90%
97.19 to 115.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection US-licensed Humira, EU-approved Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value92.63
Confidence Interval (2-Sided) 90%
85.29 to 100.61
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CT-P17, EU-approved Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value98.00
Confidence Interval (2-Sided) 90%
90.06 to 106.63
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
TitleArea Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
DescriptionPrimary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Time Frameup to Day 71

Outcome Measure Data

Analysis Population Description
Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab)
Arm/Group TitleCT-P17US-licensed HumiraEU-approved Humira
Arm/Group Descriptiona single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Measure Participants969398
Mean (Standard Deviation) [h•μg/mL]
2372.7
(954.82)
2185.0
(795.91)
2394.7
(866.95)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT-P17, US-licensed Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value107.30
Confidence Interval (2-Sided) 90%
98.29 to 117.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection US-licensed Humira, EU-approved Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value93.93
Confidence Interval (2-Sided) 90%
86.08 to 102.50
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CT-P17, EU-approved Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value100.79
Confidence Interval (2-Sided) 90%
92.42 to 109.92
Parameter Dispersion Type:
Value:
Estimation Comments
3. Primary Outcome
TitleMaximum Serum Concentration (Cmax)
DescriptionPrimary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Time Frameup to Day 71

Outcome Measure Data

Analysis Population Description
Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab)
Arm/Group TitleCT-P17US-licensed HumiraEU-approved Humira
Arm/Group Descriptiona single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Measure Participants969398
Mean (Standard Deviation) [μg/mL]
3.619
(1.3522)
3.556
(1.1972)
3.660
(1.2212)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection CT-P17, US-licensed Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value101.89
Confidence Interval (2-Sided) 90%
95.33 to 108.89
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection US-licensed Humira, EU-approved Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value98.20
Confidence Interval (2-Sided) 90%
91.91 to 104.92
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection CT-P17, EU-approved Humira
Comments Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight.
Type of Statistical Test Equivalence
Comments PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%.
Statistical Test of Hypothesisp-Value
Comments
Method
Comments
Method of EstimationEstimation ParameterRatio of geometric least squares means
Estimated Value100.05
Confidence Interval (2-Sided) 90%
93.69 to 106.85
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
TitleTime to the Maximum Serum Concentration (Tmax)
DescriptionThe secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Time Frameup to Day 71

Outcome Measure Data

Analysis Population Description
Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab)
Arm/Group TitleCT-P17US-licensed HumiraEU-approved Humira
Arm/Group Descriptiona single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Measure Participants969398
Median (Full Range) [h]
167.433
166.833
144.000
5. Secondary Outcome
TitleTerminal Elimination Half-life (t1/2)
DescriptionThe secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose.
Time Frameup to Day 71

Outcome Measure Data

Analysis Population Description
Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab)
Arm/Group TitleCT-P17US-licensed HumiraEU-approved Humira
Arm/Group Descriptiona single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Measure Participants808689
Mean (Standard Deviation) [h]
340.3
(163.61)
331.3
(165.05)
339.5
(151.04)

Adverse Events

Time FrameAdverse events were assessed from the time the ICF was signed and until the end of the subject's participation in the study (up to Day 71).
Adverse Event Reporting Description Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized.
Arm/Group TitleCT-P17US-licensed HumiraEU-approved Humira
Arm/Group Descriptiona single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFSa single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
All Cause Mortality
CT-P17US-licensed HumiraEU-approved Humira
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/102 (0%) 0/102 (0%) 0/104 (0%)
Serious Adverse Events
CT-P17US-licensed HumiraEU-approved Humira
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total2/102 (2%) 0/102 (0%) 1/104 (1%)
Ear and labyrinth disorders
Tympanic membrane perforation1/102 (1%) 0/102 (0%) 0/104 (0%)
Injury, poisoning and procedural complications
Road traffic accident1/102 (1%) 0/102 (0%) 1/104 (1%)
Other (Not Including Serious) Adverse Events
CT-P17US-licensed HumiraEU-approved Humira
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total26/102 (25.5%) 27/102 (26.5%) 27/104 (26%)
General disorders
Injection site reaction20/102 (19.6%) 16/102 (15.7%) 19/104 (18.3%)
Infections and infestations
Nasopharyngitis3/102 (2.9%) 7/102 (6.9%) 3/104 (2.9%)
Nervous system disorders
Headache6/102 (5.9%) 6/102 (5.9%) 7/104 (6.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleSungHyun Kim
OrganizationCELLTRION, Inc.
Phone+82 32 850 5778
EmailSungHyun.Kim@celltrion.com
Responsible Party:
Celltrion
ClinicalTrials.gov Identifier:
NCT03970824
Other Study ID Numbers:
  • CT-P17 1.1
First Posted:
Jun 3, 2019
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021