Trial Outcomes & Findings for Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA) (NCT NCT02115750)
NCT ID: NCT02115750
Last Updated: 2019-06-26
Results Overview
The primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
647 participants
Primary outcome timeframe
24-weeks
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
Enbrel (Etanercept)
Enbrel 50mg subcutaneously every week for 24 Weeks.
Etanercept: Head-to-head comparison
In part 2, all subjects received 50mg subcutaneously every week from week 25-48.
|
CHS-0214
CHS-0214 50mg subcutaneously every week for 24 Weeks.
Part 2: All subjects received CHS-0214 50mg subcutaneously every week from week 25-48.
|
|---|---|---|
|
Part 1
STARTED
|
323
|
324
|
|
Part 1
COMPLETED
|
301
|
312
|
|
Part 1
NOT COMPLETED
|
22
|
12
|
|
Part 2: All Subjects Receive CHS-0214
STARTED
|
280
|
284
|
|
Part 2: All Subjects Receive CHS-0214
COMPLETED
|
269
|
272
|
|
Part 2: All Subjects Receive CHS-0214
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Rheumatoid Arthritis (RA)
Baseline characteristics by cohort
| Measure |
Enbrel (Etanercept)
n=320 Participants
Enbrel 50mg weekly times 24 weeks.
Etanercept: Head-to-head comparison
|
CHS-0214
n=324 Participants
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
|
Total
n=644 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
|
280 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
565 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
254 Participants
n=5 Participants
|
260 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
66 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
211 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
424 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
98 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
197 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
307 Participants
n=5 Participants
|
313 Participants
n=7 Participants
|
620 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24-weeksThe primary efficacy endpoint in Part 1 was the percentage of subjects who achieved ACR20 (20% improvement according to American College of Rheumatology criteria) at week 24 compared to baseline (last non-missing value prior to first dose). Subjects were considered an ACR20 responder if when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC (Swollen joint count), 20% decrease in TJC (Tender joint count), and 20% improvement in 3 of the following 5 measures: high sensitivity C reactive protein(hs-CRP), Health Assessment Questionnaire Disability Index(HAQ-DI), subjects global assessment of pain(SPA, VAS), subject's global assessment of disease activity(SGA-VAS), physician's global assessment of disease activity(PGA-VAS)
Outcome measures
| Measure |
Enbrel (Etanercept)
n=256 Participants
Enbrel 50mg weekly times 24 weeks.
Etanercept: Head-to-head comparison
|
CHS-0214
n=256 Participants
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
|
|---|---|---|
|
ACR-20 - 20% Improvement According to American College of Rheumatology Criteria
|
232 Participants
|
233 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12 and 18Subjects were considered an ACR20 responder if, when compared to baseline (last non-missing value prior to first dose), they achieved a 20% decrease in SJC, 20% decrease in TJC, and 20% improvement in 3 of the following 5 measures: * High sensitivity C-reactive protein (hs-CRP); * Health Assessment Questionnaire-Disability Index (HAQ-DI); * Subject's global assessment of pain (ie, subject's pain assessment \[SPA\]-visual analog scale \[VAS\]); * Subject's global assessment of disease activity (SGA-VAS); and * Physician's global assessment of disease activity (PGA-VAS). In these calculations, the percent change from baseline to endpoint was used to determine ACR20. For percentage change calculations, results were rounded to 5 decimal places prior to comparing to the threshold of 20%.For SJCs and TJCs, the assessment of efficacy was based on mean change from baseline (last non-missing value prior to first dose evaluation).
Outcome measures
| Measure |
Enbrel (Etanercept)
n=323 Participants
Enbrel 50mg weekly times 24 weeks.
Etanercept: Head-to-head comparison
|
CHS-0214
n=324 Participants
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
|
|---|---|---|
|
ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18
Week 12
|
73.8 percentage of participants
|
74.6 percentage of participants
|
|
ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18
Week 4
|
48.8 percentage of participants
|
56.6 percentage of participants
|
|
ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18
Week 8
|
59.4 percentage of participants
|
71.1 percentage of participants
|
|
ACR20 - (20% Improvement According to American College of Rheumatology Criteria) at Weeks 4, 8, 12, and 18
Week 18
|
75 percentage of participants
|
77.3 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4,8,12,18,24,28,36,48Population: The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.
The average percent improvement from baseline in individual ACR response criteria: TJC (Tender joint count) the 66/68 Joint Count evaluates 68 joints for tenderness and pain with movement. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count. Hip joints can be evaluated for tenderness.
Outcome measures
| Measure |
Enbrel (Etanercept)
n=256 Participants
Enbrel 50mg weekly times 24 weeks.
Etanercept: Head-to-head comparison
|
CHS-0214
n=256 Participants
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
|
|---|---|---|
|
Summary of Change in Tender Joint Count (TJC) by Study Visit
TJC - Week 4
|
-9.4 Joints
Standard Deviation 9.13
|
-10.3 Joints
Standard Deviation 9.89
|
|
Summary of Change in Tender Joint Count (TJC) by Study Visit
TJC - Week 8
|
-11.8 Joints
Standard Deviation 10.00
|
-13.2 Joints
Standard Deviation 11.21
|
|
Summary of Change in Tender Joint Count (TJC) by Study Visit
TJC - Week 12
|
-13.9 Joints
Standard Deviation 10.21
|
-14.7 Joints
Standard Deviation 11.05
|
|
Summary of Change in Tender Joint Count (TJC) by Study Visit
TJC - Week 18
|
-15.4 Joints
Standard Deviation 10.51
|
-16.4 Joints
Standard Deviation 11.91
|
|
Summary of Change in Tender Joint Count (TJC) by Study Visit
TJC - Week 24
|
-16.8 Joints
Standard Deviation 11.31
|
-18.0 Joints
Standard Deviation 12.41
|
|
Summary of Change in Tender Joint Count (TJC) by Study Visit
TJC - Week 28
|
-0.2 Joints
Standard Deviation 4.39
|
0.0 Joints
Standard Deviation 4.49
|
|
Summary of Change in Tender Joint Count (TJC) by Study Visit
TJC - Week 36
|
-0.5 Joints
Standard Deviation 4.89
|
0.2 Joints
Standard Deviation 6.39
|
|
Summary of Change in Tender Joint Count (TJC) by Study Visit
TJC - Week 48
|
-1.0 Joints
Standard Deviation 5.05
|
-0.4 Joints
Standard Deviation 4.96
|
SECONDARY outcome
Timeframe: Weeks 4,8,12,18,24,28,36,48Population: The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.
The 66/68 Joint Count evaluates 66 joints for swelling. The temporomandibular, sternoclavicular, acromioclavicular, shoulder, elbow, wrist, metacarpophalangeal (MCP), proximal interphalangeal (PIP), distal interphalangeal (DIP), hip, knee, ankle, tarsus, metatarsophalangeal (MTP), and interphalangeal of the feet are included in this joint count.
Outcome measures
| Measure |
Enbrel (Etanercept)
n=256 Participants
Enbrel 50mg weekly times 24 weeks.
Etanercept: Head-to-head comparison
|
CHS-0214
n=256 Participants
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
|
|---|---|---|
|
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Week 4
|
-7.1 Joints
Standard Deviation 7.62
|
-7.3 Joints
Standard Deviation 6.98
|
|
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Week 8
|
-8.9 Joints
Standard Deviation 7.85
|
-9.5 Joints
Standard Deviation 7.18
|
|
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Week 12
|
-10.0 Joints
Standard Deviation 8.09
|
-10.2 Joints
Standard Deviation 7.76
|
|
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Week 18
|
-10.7 Joints
Standard Deviation 8.50
|
-11.1 Joints
Standard Deviation 7.98
|
|
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Week 24
|
-11.9 Joints
Standard Deviation 8.15
|
-12.3 Joints
Standard Deviation 7.78
|
|
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Week 28
|
-0.3 Joints
Standard Deviation 2.79
|
0.1 Joints
Standard Deviation 3.50
|
|
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Week 36
|
-0.7 Joints
Standard Deviation 2.96
|
-0.1 Joints
Standard Deviation 3.83
|
|
Summary of Change in Swollen Joint Count (SJC) by Study Visit
Week 48
|
-0.9 Joints
Standard Deviation 3.47
|
-0.5 Joints
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: Weeks 4,8,12,18,24,28,36,48Population: The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.
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.
Outcome measures
| Measure |
Enbrel (Etanercept)
n=256 Participants
Enbrel 50mg weekly times 24 weeks.
Etanercept: Head-to-head comparison
|
CHS-0214
n=256 Participants
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
|
|---|---|---|
|
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Week 4
|
-0.313 Units on a Scale
Standard Deviation 0.414
|
-0.266 Units on a Scale
Standard Deviation 0.391
|
|
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Week 8
|
-0.377 Units on a Scale
Standard Deviation 0.477
|
-0.401 Units on a Scale
Standard Deviation 0.473
|
|
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Week 12
|
-0.444 Units on a Scale
Standard Deviation 0.497
|
-0.466 Units on a Scale
Standard Deviation 0.506
|
|
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Week 18
|
-0.493 Units on a Scale
Standard Deviation 0.532
|
-0.529 Units on a Scale
Standard Deviation 0.540
|
|
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Week 24
|
-0.594 Units on a Scale
Standard Deviation 0.609
|
-0.614 Units on a Scale
Standard Deviation 0.556
|
|
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Week 28
|
0.01 Units on a Scale
Standard Deviation 0.243
|
0.03 Units on a Scale
Standard Deviation 0.233
|
|
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Week 36
|
0.01 Units on a Scale
Standard Deviation 0.293
|
-0.01 Units on a Scale
Standard Deviation 0.272
|
|
Summary of Change in Health Assessment Questionnaire - Disability Index (HAQ-DI) by Study Visit
Week 48
|
-0.05 Units on a Scale
Standard Deviation 0.279
|
-0.06 Units on a Scale
Standard Deviation 0.309
|
SECONDARY outcome
Timeframe: Weeks 4,8,12,18,24,28,36,48Population: The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.
The score range for the SPA-VAS is 0-100 millimeters. One total score was reported for each assessment, no subscales exist. A lower score on the left side represents a better outcome (less pain) and the higher score is on the right side representing a worse outcome (more pain).
Outcome measures
| Measure |
Enbrel (Etanercept)
n=256 Participants
Enbrel 50mg weekly times 24 weeks.
Etanercept: Head-to-head comparison
|
CHS-0214
n=256 Participants
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
|
|---|---|---|
|
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Week 4
|
-18.5 Units on a scale
Standard Deviation 22.68
|
-20.2 Units on a scale
Standard Deviation 22.60
|
|
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Week 8
|
-23.4 Units on a scale
Standard Deviation 25.43
|
-27.1 Units on a scale
Standard Deviation 22.73
|
|
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Week 12
|
-27.7 Units on a scale
Standard Deviation 25.86
|
-29.3 Units on a scale
Standard Deviation 23.12
|
|
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Week 18
|
-31.8 Units on a scale
Standard Deviation 24.89
|
-33.3 Units on a scale
Standard Deviation 25.31
|
|
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Week 24
|
-38.2 Units on a scale
Standard Deviation 22.44
|
-38.1 Units on a scale
Standard Deviation 24.01
|
|
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Week 28
|
1.9 Units on a scale
Standard Deviation 14.25
|
1.0 Units on a scale
Standard Deviation 12.68
|
|
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Week 36
|
1.6 Units on a scale
Standard Deviation 17.16
|
-0.1 Units on a scale
Standard Deviation 15.14
|
|
Summary of Change in Subject's Pain Assessment - Visual Analog Scale (SPA-VAS) by Study Visit
Week 48
|
-0.9 Units on a scale
Standard Deviation 16.89
|
-1.8 Units on a scale
Standard Deviation 16.99
|
SECONDARY outcome
Timeframe: Weeks 4,8,12,18,24,28,36,48Population: The full analysis population differs between part one (weeks 0 to 24) and part two (weeks 25 to 48) because part two does not include the full population that began the study.
The score range for PGA-VAS is 0-100 millimeters. The patient's assessment of disease activity - with the lowest score on the left side representing "none" to the highest score on the right side representing "extremely active".
Outcome measures
| Measure |
Enbrel (Etanercept)
n=256 Participants
Enbrel 50mg weekly times 24 weeks.
Etanercept: Head-to-head comparison
|
CHS-0214
n=256 Participants
CHS-0214 50mg weekly times 24 weeks.
CHS-0214
|
|---|---|---|
|
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Week 4
|
-24.1 Units on a Scale
Standard Deviation 19.04
|
-24.3 Units on a Scale
Standard Deviation 18.23
|
|
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Week 8
|
-29.6 Units on a Scale
Standard Deviation 19.76
|
-31.7 Units on a Scale
Standard Deviation 19.96
|
|
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Week 12
|
-33.5 Units on a Scale
Standard Deviation 20.99
|
-35.4 Units on a Scale
Standard Deviation 19.57
|
|
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Week 18
|
-36.3 Units on a Scale
Standard Deviation 20.69
|
-38.8 Units on a Scale
Standard Deviation 19.60
|
|
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Week 24
|
-40.5 Units on a Scale
Standard Deviation 19.31
|
-43.2 Units on a Scale
Standard Deviation 17.73
|
|
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Week 28
|
0.3 Units on a Scale
Standard Deviation 11.47
|
0.7 Units on a Scale
Standard Deviation 8.74
|
|
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Week 36
|
-1.4 Units on a Scale
Standard Deviation 10.75
|
-0.5 Units on a Scale
Standard Deviation 11.80
|
|
Summary of Change in Physician's Global Assessment- Visual Assessment Scale (PGA-VAS) by Study Visit
Week 48
|
-1.9 Units on a Scale
Standard Deviation 13.28
|
-0.5 Units on a Scale
Standard Deviation 11.47
|
Adverse Events
Enbrel-CHS-0214 (Etanercept)
Serious events: 27 serious events
Other events: 245 other events
Deaths: 0 deaths
CHS-0214-CHS-0214
Serious events: 20 serious events
Other events: 241 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enbrel-CHS-0214 (Etanercept)
n=320 participants at risk
Enbrel 50mg weekly times 24 weeks and CHS-0214 for weeks 25 to 48.
Etanercept: Head-to-head comparison
|
CHS-0214-CHS-0214
n=604 participants at risk
CHS-0214 50mg weekly times 48 weeks.
CHS-0214
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Abscess Limb
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Gastroenteritis
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Pilonidal Cyst
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Pyelonephritis
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Sepsis
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.33%
2/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Cardiac disorders
Angina Unstable
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix Carcinoma
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive Ductal Breast Carcinoma
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Ovarian Tumor
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Neoplasma
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.62%
2/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary Thyroid Cancer
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Injury, poisoning and procedural complications
Peripheral Nerve Injury
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Injury, poisoning and procedural complications
Facial Bones Fracture
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Cardiac disorders
Myocardial Ischemia
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis Allergic
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disorder
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Vascular disorders
Hypertension
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Investigations
Blood Creatine Phosphokinase Increase
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
0.00%
0/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.17%
1/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Nervous system disorders
Ischemic Stroke
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Eye disorders
Age-Related Macular Degeneration
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.31%
1/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.00%
0/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
Other adverse events
| Measure |
Enbrel-CHS-0214 (Etanercept)
n=320 participants at risk
Enbrel 50mg weekly times 24 weeks and CHS-0214 for weeks 25 to 48.
Etanercept: Head-to-head comparison
|
CHS-0214-CHS-0214
n=604 participants at risk
CHS-0214 50mg weekly times 48 weeks.
CHS-0214
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.2%
39/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
7.6%
46/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Urinary Tract Infection
|
5.3%
17/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
3.6%
22/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.0%
32/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
2.6%
16/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Bronchitis
|
4.1%
13/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.8%
11/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Sinusitis
|
3.1%
10/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.5%
9/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Cystitis
|
2.2%
7/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.3%
8/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Respiratory Tract Infection - Viral
|
0.94%
3/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.3%
8/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Herpes Zoster
|
1.6%
5/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.2%
7/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Infections and infestations
Oral Herpes
|
3.1%
10/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.2%
7/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
3.4%
11/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.7%
10/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
3.1%
10/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.3%
8/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.2%
7/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.83%
5/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
5/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.5%
9/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Gastrointestinal disorders
Diarrhea
|
2.2%
7/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
0.99%
6/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Investigations
Alanine Aminotransferase Increased
|
4.7%
15/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
2.2%
13/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Investigations
Aspartate Aminotransferase Increase
|
4.1%
13/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.2%
7/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
7.8%
25/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
5.6%
34/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
General disorders
injection Site Reaction
|
13.8%
44/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.5%
9/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Nervous system disorders
Headache
|
2.5%
8/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
3.3%
20/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
4/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.2%
7/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.4%
11/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
2.0%
12/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Vascular disorders
Hypertension
|
4.1%
13/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
2.0%
12/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
8/320 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
1.2%
7/604 • In part one, subjects were randomized to receive either Enbrel or CHS-0214 for 24 weeks. In part two, all participants receive CHS-0214 for the remainder of the study (Weeks 25-48)
Adverse events were reported for CHS-0214 and Enbrel using two arms. Part 1 (Weeks 1-24) and 2 (Weeks 25-48) were combined in reporting of adverse events, given that all subjects received CHS-0214 in Part 2. Adverse events were reported for both arms with the first arm being CHS-0214 in both parts of the study and the second arm being patients who received Enbrel in Part 1 of the study and switched to CHS-0214.
|
Additional Information
Barbara K. Finck, MD Chief Medical Officer
Coherus BioSciences, Inc
Phone: 650-649-3529
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place