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Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02134210
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : May 13, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Coherus Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Etanercept
Drug: CHS-0214
Enrollment 521
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Period Title: Part One: Weeks 0-12
Started 260 261
Completed 241 255
Not Completed 19 6
Period Title: Part Two: Weeks 13-48
Started 241 255
Completed 211 227
Not Completed 30 28
Arm/Group Title Enbrel (Etanercept) CHS-0214 Total
Hide Arm/Group Description

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214

 Total of all reporting groups
Overall Number of Baseline Participants 260 261 521
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 260 participants 261 participants 521 participants
43.1  (13.75) 44.3  (12.86) 43.7  (13.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 261 participants 521 participants
Female
80
  30.8%
76
  29.1%
156
  29.9%
Male
180
  69.2%
185
  70.9%
365
  70.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 261 participants 521 participants
Hispanic or Latino
20
   7.7%
20
   7.7%
40
   7.7%
Not Hispanic or Latino
240
  92.3%
241
  92.3%
481
  92.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 260 participants 261 participants 521 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
11
   4.2%
5
   1.9%
16
   3.1%
Native Hawaiian or Other Pacific Islander
1
   0.4%
0
   0.0%
1
   0.2%
Black or African American
2
   0.8%
4
   1.5%
6
   1.2%
White
236
  90.8%
242
  92.7%
478
  91.7%
More than one race
7
   2.7%
9
   3.4%
16
   3.1%
Unknown or Not Reported
3
   1.2%
1
   0.4%
4
   0.8%
1.Primary Outcome
Title Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12
Hide Description

The Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis.

Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US.
Time Frame 12-weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Measure Type: Number
Unit of Measure: participants
142 147
2.Primary Outcome
Title Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks
Hide Description Mean percent changed in PASI from baseline (last non-missing value prior to first dose) at Week 12. This was the primary endpoint supporting the Marketing Authorization Application in the EU.
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 226 228
Mean (Standard Deviation)
Unit of Measure: percentage of change
-73.4  (25.0) -76.7  (21.1)
3.Secondary Outcome
Title Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Hide Description Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48
Time Frame Weeks 4, 8, 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Part 2 of the study took place from week 13-48 and not all subjects that started the study were included in analysis
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Mean (Standard Deviation)
Unit of Measure: percentage of change
Week 4 Number Analyzed 228 participants 228 participants
-42.1  (24.93) -43.2  (22.63)
Week 8 Number Analyzed 228 participants 228 participants
-62.8  (24.23) -65.7  (22.16)
Week 12 Number Analyzed 228 participants 228 participants
-76.0  (21.96) -77.0  (20.74)
Week 24 Number Analyzed 213 participants 225 participants
-83.3  (17.5) -80.8  (20.43)
Week 36 Number Analyzed 213 participants 225 participants
-82.8  (20.44) -81.9  (18.55)
Week 48 Number Analyzed 213 participants 225 participants
82.9  (18.55) -80.9  (25.08)
4.Secondary Outcome
Title Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Hide Description The proportion of subjects who achieved PASI-75 (75% Improvement in Psoriasis Area and Severity Index) from baseline at Weeks 4, 8, 12, 24, 36, and 48.
Time Frame Weeks 4, 8, 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 260 261
Measure Type: Count of Participants
Unit of Measure: Participants
Week 4
221
  85.0%
228
  87.4%
Week 8
213
  81.9%
225
  86.2%
Week 12
213
  81.9%
225
  86.2%
Week 24
204
  78.5%
221
  84.7%
Week 36
195
  75.0%
211
  80.8%
Week 48
178
  68.5%
203
  77.8%
5.Secondary Outcome
Title Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Hide Description The proportion of subjects who achieved a 50% improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% improvement in PASI (PASI-90) response rates from baseline at Weeks 4, 8, 12, 24, 36, and 48
Time Frame Weeks 4, 8, 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Measure Type: Number
Unit of Measure: participants
Week 4 PASI-50 86 89
Week 4 PASI-90 8 6
Week 8 PASI-50 155 173
Week 8 PASI-90 25 28
Week 12 PASI-50 184 200
Week 12 PASI-90 57 69
Week 24 PASI-50 194 201
Week 24 PASI-90 89 99
Week 36 PASI-50 183 197
Week 36 PASI-90 92 93
Week 48 PASI-50 169 189
Week 48 PASI-90 81 91
6.Secondary Outcome
Title Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Hide Description

Change in PSGA (Physician's Static Global Assessment) of disease activity on a scale of 0 to 5 from baseline to Weeks 4, 8, 12, 24, 36, and 48.

Minimum Value: 0 Maximum Value: 5

The PSGA of PsO (Psoriasis) was assessed on a scale of 0 to 5, with 0 indicating no PsO (clear of disease),1 (almost clear), and 2 or higher scores indicating more severe disease. Subjects with a clear (0) or almost clear (1) evaluation were considered PSGA responders.
Time Frame 4, 8, 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Mean (Standard Deviation)
Unit of Measure: score on a scale
Week 4 -1.2  (0.83) -1.2  (0.81)
Week 8 -1.8  (0.94) -1.17  (0.88)
Week 12 -2.1  (1.05) -2.1  (0.97)
Week 24 -2.2  (1.5) -2.2  (1.07)
Week 36 -2.2  (1.17) -2.1  (1.10)
Week 48 -2.1  (1.11) -2.1  (1.15)
7.Secondary Outcome
Title The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Hide Description

The proportion of subjects with a change in a PSGA (Physician's Static Global Assessment) score = 0 to 1, demonstrating clear or almost clear skin at Weeks 4, 8, 12, 24, 36, and 48;

Minimum: 0 Maximum: 1 Subjects with a clear(0) or almost clear(1) evaluation were considered PSGA responders.
Time Frame Weeks 4, 8, 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 260 261
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 17.1 17.2
Week 8 39.3 43.7
Week 12 59.1 60.7
Week 24 62.4 64.7
Week 36 64.6 60.8
Week 48 62.4 65.5
8.Secondary Outcome
Title Change in Subject's Global Assessment (SGA) of PsO
Hide Description Change in Subject's Global Assessment (SGA) of PsO from baseline to Weeks 4, 8, 12, 24, 36, and 48. The SGA of PsO was assessed using VAS (visual analog scale in the unit of millimeters) , ranging from 0 (good) to 100 (severe). The SGA was assessed at randomization (Week 0/Day 0) and Weeks 4, 8, 12, 24, 36, and 48, as well as at the Follow-up Visit, if applicable. The change in SGA is the value at baseline minus sum of values at weeks 4, 8, 12, 24, 36, and 48. Since the change in SGA is measured from baseline, a negative value indicates a decrease in overall SGA and better overall assessment of PsO.
Time Frame Weeks 4, 8, 12, 24, 36, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Part 2 of the study(weeks 13-48) did not include the full analysis population from part 1 of the study.
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 4 Number Analyzed 228 participants 228 participants
-23.0  (25.11) -24.0  (22.59)
Week 8 Number Analyzed 228 participants 228 participants
-37.1  (25.97) -35.0  (25.15)
Week 12 Number Analyzed 228 participants 228 participants
-45.7  (25.62) -45.1  (27.81)
Week 24 Number Analyzed 213 participants 225 participants
-50.1  (28.50) -47.2  (28.98)
Week 36 Number Analyzed 213 participants 225 participants
-46.9  (29.23) -47.4  (29.95)
Week 48 Number Analyzed 213 participants 225 participants
-50.0  (28.29) -48.7  (30.12)
9.Secondary Outcome
Title Change in DLQI (Dermatology Life Quality Index)
Hide Description

Change in DLQI (Dermatology Life Quality Index) from baseline to Weeks 12, 24, and 48

The DLQI is a 10-question validated questionnaire that was performed at screening, randomization (Week 0/Day 0), and Weeks 12, 24, and 48. It was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired.
Time Frame Weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Part 2 (weeks 13-48) of the study did not include the full analysis population from part 1
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline Number Analyzed 213 participants 225 participants
17.9  (5.7) 18.6  (5.86)
Week 12 Number Analyzed 228 participants 228 participants
-12.7  (6.2) -13.4  (7.18)
Week 24 Number Analyzed 213 participants 225 participants
-14.3  (6.24) -14.4  (6.85)
Week 48 Number Analyzed 213 participants 225 participants
-13.9  (6.32) -14.3  (6.81)
10.Secondary Outcome
Title Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Hide Description

Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) from baseline to Weeks 12, 24, and 48

The EQ-5D was performed at randomization (Week 0/Day 0), and Weeks 12, 24, and 48. The EQ-5D is a generic (non-disease specific), preference-based health-related quality of life measure based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions).
Time Frame Weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Part 2 (weeks 13-48) of the study did not include the full analysis population from part 1
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 - Mobility Number Analyzed 228 participants 228 participants
-0.3  (0.81) -0.3  (0.83)
Week 12 - Self Care Number Analyzed 213 participants 225 participants
-0.2  (0.70) -0.3  (0.73)
Week 12 - Usual Activities Number Analyzed 213 participants 225 participants
-0.6  (0.94) -0.4  (0.91)
Week 12 - Pain/Discomfort Number Analyzed 213 participants 225 participants
-0.9  (1.12) -0.9  (1.1)
Week 12 - Anxiety/Depression Number Analyzed 213 participants 225 participants
-0.6  (1.01) -0.7  (1.01)
Week 24 - Mobility Number Analyzed 213 participants 225 participants
-0.3  (0.93) -0.3  (0.80)
Week 24 - Self Care Number Analyzed 213 participants 225 participants
-0.2  (0.70) -0.3  (0.75)
Week 24 - Usual Activities Number Analyzed 228 participants 228 participants
-0.6  (0.96) -0.5  (0.93)
Week 24 - Pain/Discomfort Number Analyzed 213 participants 225 participants
-1.0  (1.12) -0.9  (1.08)
Week 24 - Anxiety/Depression Number Analyzed 213 participants 225 participants
-0.7  (1.10) -0.7  (1.06)
Week 48 - Mobility Number Analyzed 213 participants 225 participants
-0.4  (0.84) -0.3  (0.90)
Week 48 - Self Care Number Analyzed 213 participants 225 participants
-0.3  (0.70) -0.3  (0.76)
Week 48 - Usual Activities Number Analyzed 213 participants 225 participants
-0.7  (0.95) -0.4  (0.98)
Week 48 - Pain/Discomfort Number Analyzed 213 participants 225 participants
-1.0  (1.18) -0.8  (1.13)
Week 48 - Anxiety/Depression Number Analyzed 213 participants 225 participants
-0.7  (1.08) -0.6  (1.16)
11.Secondary Outcome
Title Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Hide Description HAQ-DI - Scales for each question range from 0-3 (0=without any difficulty; 1=with some difficulty; 2=with much difficulty; 3=Unable to do). The "total" for each category is determined by the highest score (greatest difficulty) for that category. The score for the disability index is the mean of the eight category scores. If more than 2 of the categories or 25% are missing, the scale won't be scored. If fewer than 2 or the categories are missing, the sum of the categories was divided by the number of answered categories.
Time Frame Weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Part 2 of the study(weeks-13-48) did not include the full analysis population from part 1.
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 12 Number Analyzed 228 participants 228 participants
-0.4  (0.59) -0.4  (0.39)
Week 24 Number Analyzed 213 participants 225 participants
-0.4  (0.75) -0.5  (0.42)
Week 48 Number Analyzed 213 participants 225 participants
-0.6  (0.69) -0.4  (0.59)
12.Secondary Outcome
Title Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
Hide Description

Change in highly sensitive C-reactive protein (hs-CRP; mg/L) from baseline to Weeks 12, 24, and 48 for subjects with PsA (Psoriatic arthritis) only.

Highly sensitive C-reactive protein For subjects with PsA, change in hs-CRP from baseline to Weeks 12, 24, and 48 was assessed.
Time Frame Weeks 12, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
The population from part 2(weeks 13-48) did not include the full analysis population from part 1.
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 228 228
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline Number Analyzed 228 participants 228 participants
11.8  (29.80) 6.2  (8.39)
Week 12 Number Analyzed 228 participants 228 participants
-8.9  (32.10) -3.3  (6.63)
Week 24 Number Analyzed 213 participants 225 participants
-9.1  (31.98) -1.3  (9.69)
Week 48 Number Analyzed 213 participants 225 participants
-11.2  (33.69) -2.8  (6.01)
13.Secondary Outcome
Title The Proportion of Subjects With a Durability of Response at Week 48
Hide Description The proportion of subjects with a durability of response during Part 2. Durability of response was defined as the maintenance of the PASI-50 or greater at Weeks 24, 36, and 48 when compared to baseline (Week 0).
Time Frame Weeks 24, 36, and 48 when compared to baseline (Week 0).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description:

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
Overall Number of Participants Analyzed 213 225
Measure Type: Number
Unit of Measure: percentage of participants
Durability of Response - Yes 77 77.8
Durability of Response - No 23 22.2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enbrel (Etanercept) CHS-0214
Hide Arm/Group Description

Enbrel 50mg twice weekly times 12 weeks

Etanercept: Head-to-head comparison

CHS-0214 50mg twice weekly times 12 weeks

CHS-0214
All-Cause Mortality
Enbrel (Etanercept) CHS-0214
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Enbrel (Etanercept) CHS-0214
Affected / at Risk (%) Affected / at Risk (%)
Total   10/260 (3.85%)   7/261 (2.68%) 
Cardiac disorders     
Angina Pectoris †  1/260 (0.38%)  0/261 (0.00%) 
Atrial Fibrillation †  0/260 (0.00%)  2/261 (0.77%) 
Cardiac Failure †  0/260 (0.00%)  1/261 (0.38%) 
Gastrointestinal disorders     
Fecaloma †  0/260 (0.00%)  1/261 (0.38%) 
Hemorrhoidal Hemorrhage †  1/260 (0.38%)  0/261 (0.00%) 
Inguinal Hernia †  0/260 (0.00%)  1/261 (0.38%) 
Esophageal Varices Hemorrhage †  1/260 (0.38%)  0/261 (0.00%) 
General disorders     
Chest Pain †  1/260 (0.38%)  0/261 (0.00%) 
Infections and infestations     
Bartholin's Abscess †  0/260 (0.00%)  1/261 (0.38%) 
Lobar Pneumonia †  0/260 (0.00%)  1/261 (0.38%) 
Injury, poisoning and procedural complications     
Foot Fracture †  1/260 (0.38%)  0/261 (0.00%) 
Investigations     
Transaminases Increased †  1/260 (0.38%)  0/261 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis †  1/260 (0.38%)  0/261 (0.00%) 
Back Pain †  1/260 (0.38%)  0/261 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Intraductal Proliferative Breast Lesion †  1/260 (0.38%)  0/261 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease †  0/260 (0.00%)  1/261 (0.38%) 
Epistaxis †  1/260 (0.38%)  0/261 (0.00%) 
Pickwickian Syndrome †  0/260 (0.00%)  1/261 (0.38%) 
Skin and subcutaneous tissue disorders     
Psoriasis †  1/260 (0.38%)  0/261 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Enbrel (Etanercept) CHS-0214
Affected / at Risk (%) Affected / at Risk (%)
Total   156/260 (60.00%)   106/261 (40.61%) 
Infections and infestations     
Nasopharyngitis †  42/260 (16.15%)  40/261 (15.33%) 
Upper Respiratory Infection †  27/260 (10.38%)  24/261 (9.20%) 
Urinary Tract Infection †  13/260 (5.00%)  8/261 (3.07%) 
Injury, poisoning and procedural complications     
Injection Site Reaction †  46/260 (17.69%)  11/261 (4.21%) 
Skin and subcutaneous tissue disorders     
Psoriasis †  14/260 (5.38%)  10/261 (3.83%) 
Vascular disorders     
Hypertension †  14/260 (5.38%)  13/261 (4.98%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Barbara K. Finck, MD Chief Medical Officer
Organization: Coherus BioSciences, Inc
Phone: 650-649-3529
EMail: Bfinck@coherus.com
Layout table for additonal information
Responsible Party: Coherus Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02134210    
Other Study ID Numbers: CHS-0214-04
First Submitted: May 7, 2014
First Posted: May 9, 2014
Results First Submitted: December 13, 2018
Results First Posted: May 13, 2019
Last Update Posted: June 28, 2019