Trial · NCT02134210
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
NCT02134210, Phase 3, Completed, Coherus Oncology, Inc.; results first posted 2019-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO). Trials, record NCT02134210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02134210
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
- NCT number
- NCT02134210
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 521 participants, actual
- Lead sponsor
- Coherus Oncology, Inc.
- Conditions
- Plaque Psoriasis
- Interventions
- Etanercept, CHS-0214
- First posted
- 2014-05-09
- Last updated
- 2019-06-28
- Results first posted
- 2019-05-13
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 | 12-weeks | The Psoriasis Area and Severity Index (PASI) is well established in the medical literature and is internationally the most widely used instrument to assess the severity of Psoriasis. Proportion of subjects achieving PASI-75 from baseline at Week 12. This was the primary endpoint supporting a Biologics Licensing Application in the US. |
| Primary | Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks | 12 Weeks | Mean percent changed in PASI from baseline (last non-missing value prior to first dose) at Week 12. This was the primary endpoint supporting the Marketing Authorization Application in the EU. |
| Secondary | Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline | Weeks 4, 8, 12, 24, 36, and 48 | Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48 |
| Secondary | Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index) | Weeks 4, 8, 12, 24, 36, and 48 | The proportion of subjects who achieved PASI-75 (75% Improvement in Psoriasis Area and Severity Index) from baseline at Weeks 4, 8, 12, 24, 36, and 48. |
| Secondary | Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90) | Weeks 4, 8, 12, 24, 36, and 48 | The proportion of subjects who achieved a 50% improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% improvement in PASI (PASI-90) response rates from baseline at Weeks 4, 8, 12, 24, 36, and 48 |
| Secondary | Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5 | 4, 8, 12, 24, 36, and 48 | Change in PSGA (Physician's Static Global Assessment) of disease activity on a scale of 0 to 5 from baseline to Weeks 4, 8, 12, 24, 36, and 48. Minimum Value: 0 Maximum Value: 5 The PSGA of PsO (Psoriasis) was assessed on a scale of 0 to 5, with 0 indicating no PsO (clear of disease),1 (almost clear), and 2 or higher scores indicating more severe disease. Subjects with a clear (0) or almost clear (1) evaluation were considered PSGA responders. |
| Secondary | The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1 | Weeks 4, 8, 12, 24, 36, and 48 | The proportion of subjects with a change in a PSGA (Physician's Static Global Assessment) score = 0 to 1, demonstrating clear or almost clear skin at Weeks 4, 8, 12, 24, 36, and 48; Minimum: 0 Maximum: 1 Subjects with a clear(0) or almost clear(1) evaluation were considered PSGA responders. |
| Secondary | Change in Subject's Global Assessment (SGA) of PsO | Weeks 4, 8, 12, 24, 36, and 48 | Change in Subject's Global Assessment (SGA) of PsO from baseline to Weeks 4, 8, 12, 24, 36, and 48. The SGA of PsO was assessed using VAS (visual analog scale in the unit of millimeters) , ranging from 0 (good) to 100 (severe). The SGA was assessed at randomization (Week 0/Day 0) and Weeks 4, 8, 12, 24, 36, and 48, as well as at the Follow-up Visit, if applicable. The change in SGA is the value at baseline minus sum of values at weeks 4, 8, 12, 24, 36, and 48. Since the change in SGA is measured from baseline, a negative value indicates a decrease in overall SGA and better overall assessment of PsO. |
| Secondary | Change in DLQI (Dermatology Life Quality Index) | Weeks 12, 24, and 48 | Change in DLQI (Dermatology Life Quality Index) from baseline to Weeks 12, 24, and 48 The DLQI is a 10-question validated questionnaire that was performed at screening, randomization (Week 0/Day 0), and Weeks 12, 24, and 48. It was calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired. |
| Secondary | Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) | Weeks 12, 24, and 48 | Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) from baseline to Weeks 12, 24, and 48 The EQ-5D was performed at randomization (Week 0/Day 0), and Weeks 12, 24, and 48. The EQ-5D is a generic (non-disease specific), preference-based health-related quality of life measure based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 | 12-weeks | participants | NUMBER | |
| PRIMARY | Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks | 12 Weeks | percentage of change | MEAN | |
| SECONDARY | Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline | Weeks 4, 8, 12, 24, 36, and 48 | Part 2 of the study took place from week 13-48 and not all subjects that started the study were included in analysis | percentage of change | MEAN |
| SECONDARY | Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index) | Weeks 4, 8, 12, 24, 36, and 48 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90) | Weeks 4, 8, 12, 24, 36, and 48 | participants | NUMBER | |
| SECONDARY | Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5 | 4, 8, 12, 24, 36, and 48 | score on a scale | MEAN | |
| SECONDARY | The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1 | Weeks 4, 8, 12, 24, 36, and 48 | percentage of participants | NUMBER | |
| SECONDARY | Change in Subject's Global Assessment (SGA) of PsO | Weeks 4, 8, 12, 24, 36, and 48 | Part 2 of the study(weeks 13-48) did not include the full analysis population from part 1 of the study. | units on a scale | MEAN |
| SECONDARY | Change in DLQI (Dermatology Life Quality Index) | Weeks 12, 24, and 48 | Part 2 (weeks 13-48) of the study did not include the full analysis population from part 1 | score on a scale | MEAN |
| SECONDARY | Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D) | Weeks 12, 24, and 48 | Part 2 (weeks 13-48) of the study did not include the full analysis population from part 1 | units on a scale | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 | Enbrel (Etanercept) | 142 | participants | ||
| Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 | CHS-0214 | 147 | participants | ||
| Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks | Enbrel (Etanercept) | -73.4 | Standard Deviation 25.0 | percentage of change | |
| Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks | CHS-0214 | -76.7 | Standard Deviation 21.1 | percentage of change | |
| Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline | Enbrel (Etanercept) | Week 4 | -42.1 | Standard Deviation 24.93 | percentage of change |
| Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline | CHS-0214 | Week 4 | -43.2 | Standard Deviation 22.63 | percentage of change |
| Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline | Enbrel (Etanercept) | Week 8 | -62.8 | Standard Deviation 24.23 | percentage of change |
| Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline | CHS-0214 | Week 8 | -65.7 | Standard Deviation 22.16 | percentage of change |
| Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline | Enbrel (Etanercept) | Week 12 | -76.0 | Standard Deviation 21.96 | percentage of change |
| Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline | CHS-0214 | Week 12 | -77.0 | Standard Deviation 20.74 | percentage of change |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part One: Weeks 0-12 | STARTED | Enbrel (Etanercept) | 260 | |
| Part One: Weeks 0-12 | STARTED | CHS-0214 | 261 | |
| Part One: Weeks 0-12 | COMPLETED | Enbrel (Etanercept) | 241 | |
| Part One: Weeks 0-12 | COMPLETED | CHS-0214 | 255 | |
| Part One: Weeks 0-12 | NOT COMPLETED | Enbrel (Etanercept) | 19 | |
| Part One: Weeks 0-12 | NOT COMPLETED | CHS-0214 | 6 | |
| Part Two: Weeks 13-48 | STARTED | Enbrel (Etanercept) | 241 | |
| Part Two: Weeks 13-48 | STARTED | CHS-0214 | 255 | |
| Part Two: Weeks 13-48 | COMPLETED | Enbrel (Etanercept) | 211 | |
| Part Two: Weeks 13-48 | COMPLETED | CHS-0214 | 227 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events50
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Enbrel (Etanercept) | 42 | 260 | |
| other | Nasopharyngitis | Infections and infestations | CHS-0214 | 40 | 261 | |
| other | Upper Respiratory Infection | Infections and infestations | Enbrel (Etanercept) | 27 | 260 | |
| other | Upper Respiratory Infection | Infections and infestations | CHS-0214 | 24 | 261 | |
| other | Hypertension | Vascular disorders | Enbrel (Etanercept) | 14 | 260 | |
| other | Hypertension | Vascular disorders | CHS-0214 | 13 | 261 | |
| other | Injection Site Reaction | Injury, poisoning and procedural complications | Enbrel (Etanercept) | 46 | 260 | |
| other | Injection Site Reaction | Injury, poisoning and procedural complications | CHS-0214 | 11 | 261 | |
| other | Psoriasis | Skin and subcutaneous tissue disorders | Enbrel (Etanercept) | 14 | 260 | |
| other | Psoriasis | Skin and subcutaneous tissue disorders | CHS-0214 | 10 | 261 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enbrel (Etanercept) | ||
| Total, all-cause mortality | CHS-0214 | ||
| Total, other adverse events | Enbrel (Etanercept) | 156 | 260 |
| Total, other adverse events | CHS-0214 | 106 | 261 |
| Total, serious adverse events | Enbrel (Etanercept) | 10 | 260 |
| Total, serious adverse events | CHS-0214 | 7 | 261 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enbrel (Etanercept) vs CHS-0214: Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12 | Trial comparisons |
| Enbrel (Etanercept) vs CHS-0214: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02134210
GET https://conductscience.org/api/trials/v1/NCT02134210/results?page=2