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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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)
Secondary ID [1] 0 0
CHS-0214-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etanercept

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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

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
Timepoint [1] 0 0
12-weeks
Primary outcome [2] 0 0
Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks
Timepoint [2] 0 0
12 Weeks
Secondary outcome [1] 0 0
Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
Timepoint [1] 0 0
Weeks 4, 8, 12, 24, 36, and 48
Secondary outcome [2] 0 0
Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
Timepoint [2] 0 0
Weeks 4, 8, 12, 24, 36, and 48
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)
Timepoint [3] 0 0
Weeks 4, 8, 12, 24, 36, and 48
Secondary outcome [4] 0 0
Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
Timepoint [4] 0 0
4, 8, 12, 24, 36, and 48
Secondary outcome [5] 0 0
The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
Timepoint [5] 0 0
Weeks 4, 8, 12, 24, 36, and 48
Secondary outcome [6] 0 0
Change in Subject's Global Assessment (SGA) of PsO
Timepoint [6] 0 0
Weeks 4, 8, 12, 24, 36, and 48
Secondary outcome [7] 0 0
Change in DLQI (Dermatology Life Quality Index)
Timepoint [7] 0 0
Weeks 12, 24, and 48
Secondary outcome [8] 0 0
Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
Timepoint [8] 0 0
Weeks 12, 24, and 48
Secondary outcome [9] 0 0
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Timepoint [9] 0 0
Weeks 12, 24, and 48
Secondary outcome [10] 0 0
Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
Timepoint [10] 0 0
Weeks 12, 24, and 48
Secondary outcome [11] 0 0
The Proportion of Subjects With a Durability of Response at Week 48
Timepoint [11] 0 0
Weeks 24, 36, and 48 when compared to baseline (Week 0).

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/05/2016
Sample size
Target
Accrual to date
Final
521
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
Recruitment hospital [1] 0 0
Woden Dermatology Pty - Phillip
Recruitment hospital [2] 0 0
Dr S P Shumack (St George Dermatology and Skin Cancer Center) - Kogarah
Recruitment hospital [3] 0 0
Dr S P Shumack (Central Sydney Dermatology) - Sydney
Recruitment hospital [4] 0 0
North Eastern Health Specialists - Hectorville
Recruitment hospital [5] 0 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
2606 - Phillip
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2000 - Sydney
Recruitment postcode(s) [4] 0 0
5073 - Hectorville
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Berlin
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Luebeck
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Israel
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Afula
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Israel
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Haifa
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Bialystok
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Gdansk
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Gdynia
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Pretoria
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Western Cape
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Stellenbosch
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South Africa
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Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Coherus Biosciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Shire
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Barbara K Finck, M.D.
Address 0 0
Coherus Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02134210