Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02134210
Registration number
NCT02134210
Ethics application status
Date submitted
7/05/2014
Date registered
9/05/2014
Date last updated
28/06/2019
Titles & IDs
Public title
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)
Query!
Scientific title
A Double-Blind, Randomized, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of CHS-0214 Versus Enbrel in Subjects With Chronic Plaque Psoriasis (RaPsOdy)
Query!
Secondary ID [1]
0
0
CHS-0214-04
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
0
0
Query!
Condition category
Condition code
Skin
0
0
0
0
Query!
Dermatological conditions
Query!
Skin
0
0
0
0
Query!
Other skin conditions
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Etanercept
Treatment: Drugs - CHS-0214
Active Comparator: Enbrel (etanercept) - Enbrel 50mg twice weekly times 12 weeks
Experimental: CHS-0214 - CHS-0214 50mg twice weekly times 12 weeks
Treatment: Drugs: Etanercept
Head-to-head comparison
Treatment: Drugs: CHS-0214
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
12-weeks
Query!
Primary outcome [2]
0
0
Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
12 Weeks
Query!
Secondary outcome [1]
0
0
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Query!
Assessment method [1]
0
0
Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48
Query!
Timepoint [1]
0
0
Weeks 4, 8, 12, 24, 36, and 48
Query!
Secondary outcome [2]
0
0
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Weeks 4, 8, 12, 24, 36, and 48
Query!
Secondary outcome [3]
0
0
Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
Query!
Assessment method [3]
0
0
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
Query!
Timepoint [3]
0
0
Weeks 4, 8, 12, 24, 36, and 48
Query!
Secondary outcome [4]
0
0
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
4, 8, 12, 24, 36, and 48
Query!
Secondary outcome [5]
0
0
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Weeks 4, 8, 12, 24, 36, and 48
Query!
Secondary outcome [6]
0
0
Change in Subject's Global Assessment (SGA) of PsO
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Weeks 4, 8, 12, 24, 36, and 48
Query!
Secondary outcome [7]
0
0
Change in DLQI (Dermatology Life Quality Index)
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Weeks 12, 24, and 48
Query!
Secondary outcome [8]
0
0
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Query!
Assessment method [8]
0
0
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).
Query!
Timepoint [8]
0
0
Weeks 12, 24, and 48
Query!
Secondary outcome [9]
0
0
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Query!
Assessment method [9]
0
0
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.
Query!
Timepoint [9]
0
0
Weeks 12, 24, and 48
Query!
Secondary outcome [10]
0
0
Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
Query!
Assessment method [10]
0
0
Change in highly sensitive C-reactive protein (hs-CRP; mg/L) from baseline to Weeks 12, 24, and 48 for subjects with PsA (Psoriatic arthritis) only.
Highly sensitive C-reactive protein For subjects with PsA, change in hs-CRP from baseline to Weeks 12, 24, and 48 was assessed.
Query!
Timepoint [10]
0
0
Weeks 12, 24, and 48
Query!
Secondary outcome [11]
0
0
The Proportion of Subjects With a Durability of Response at Week 48
Query!
Assessment method [11]
0
0
The proportion of subjects with a durability of response during Part 2. Durability of response was defined as the maintenance of the PASI-50 or greater at Weeks 24, 36, and 48 when compared to baseline (Week 0).
Query!
Timepoint [11]
0
0
Weeks 24, 36, and 48 when compared to baseline (Week 0).
Query!
Eligibility
Key inclusion criteria
- Male or female adults
- PsO diagnosis for 6 months
- Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment
(PSGA) score greater than or equal to 3 (based on a scale or 0-5),
- Body Surface Area (BSA) involved with PsO greater than or equal to 10%
- Dermatology Life Quality Index (DQLI) greater than or equal to 10
- Previously received phototherapy or systemic non-biologic therapy for PsO
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Forms of Psoriasis other than PsO
- Drug induced Psoriasis
- Positive QuantiFERON-tuberculosis (TB) Gold Test
- Presence of significant comorbid conditions
- Chemistry and hematology values outside protocol specified range
- Major systemic infections
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
16/06/2014
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
12/05/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
521
Query!
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Woden Dermatology Pty - Phillip
Query!
Recruitment hospital [2]
0
0
Dr S P Shumack (St George Dermatology and Skin Cancer Center) - Kogarah
Query!
Recruitment hospital [3]
0
0
Dr S P Shumack (Central Sydney Dermatology) - Sydney
Query!
Recruitment hospital [4]
0
0
North Eastern Health Specialists - Hectorville
Query!
Recruitment hospital [5]
0
0
Sinclair Dermatology - East Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2606 - Phillip
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [4]
0
0
5073 - Hectorville
Query!
Recruitment postcode(s) [5]
0
0
3002 - East Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Minnesota
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Missouri
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
New Jersey
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New York
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
North Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Ohio
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Oklahoma
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Pennsylvania
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
South Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Tennessee
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Texas
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Washington
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
West Virginia
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Alberta
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Ontario
Query!
Country [27]
0
0
Germany
Query!
State/province [27]
0
0
Berlin
Query!
Country [28]
0
0
Germany
Query!
State/province [28]
0
0
Dresden
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Erlangen
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Frankfurt
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Hamburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Luebeck
Query!
Country [33]
0
0
Israel
Query!
State/province [33]
0
0
Afula
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
Haifa
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
Petah Tikva
Query!
Country [36]
0
0
Israel
Query!
State/province [36]
0
0
Tel Aviv
Query!
Country [37]
0
0
Poland
Query!
State/province [37]
0
0
Bialystok
Query!
Country [38]
0
0
Poland
Query!
State/province [38]
0
0
Gdansk
Query!
Country [39]
0
0
Poland
Query!
State/province [39]
0
0
Gdynia
Query!
Country [40]
0
0
Poland
Query!
State/province [40]
0
0
Katowice
Query!
Country [41]
0
0
Poland
Query!
State/province [41]
0
0
Krakow
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Lodz
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Poznan
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Rzeszow
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Stalowa Wola
Query!
Country [46]
0
0
Poland
Query!
State/province [46]
0
0
Szczecin
Query!
Country [47]
0
0
Poland
Query!
State/province [47]
0
0
Torun
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Warszawa
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Wroclaw
Query!
Country [50]
0
0
South Africa
Query!
State/province [50]
0
0
Cape Town
Query!
Country [51]
0
0
South Africa
Query!
State/province [51]
0
0
Pretoria
Query!
Country [52]
0
0
South Africa
Query!
State/province [52]
0
0
Western Cape
Query!
Country [53]
0
0
South Africa
Query!
State/province [53]
0
0
Stellenbosch
Query!
Country [54]
0
0
South Africa
Query!
State/province [54]
0
0
Worcester
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Coherus Biosciences, Inc.
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Shire
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who
have not yet received any biologic therapy for any indication (other than insulin or
hormones).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02134210
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Barbara K Finck, M.D.
Query!
Address
0
0
Coherus Biosciences, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02134210
Download to PDF