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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)
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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)
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Secondary ID [1]
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CHS-0214-04
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Subjects Achieving PASI-75(75% Improvement in Psoriasis Area and Severity Index) From Baseline at Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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12-weeks
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Primary outcome [2]
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Mean Percent Change in PASI (Psoriasis Area and Severity Index) at 12 Weeks
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Assessment method [2]
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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.
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Timepoint [2]
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12 Weeks
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Secondary outcome [1]
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Mean Percent Change in PASI (Psoriasis Area and Severity Index) From Baseline
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Assessment method [1]
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Mean percent change in PASI from baseline at Weeks 4, 8, 12, 24, 36, and 48
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Timepoint [1]
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Weeks 4, 8, 12, 24, 36, and 48
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Secondary outcome [2]
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Number of Participants Who Achieved PASI - 75 (75% Improvement in Psoriasis Area and Severity Index)
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Assessment method [2]
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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.
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Timepoint [2]
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Weeks 4, 8, 12, 24, 36, and 48
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Secondary outcome [3]
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Number of Subjects Who Achieved a 50% Improvement in Psoriasis Area and Severity Index (PASI-50) and a 90% Improvement in PASI (PASI-90)
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Assessment method [3]
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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
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Timepoint [3]
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Weeks 4, 8, 12, 24, 36, and 48
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Secondary outcome [4]
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Change in PSGA (Physician's Static Global Assessment) of Disease Activity on a Scale of 0 to 5
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Assessment method [4]
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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.
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Timepoint [4]
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4, 8, 12, 24, 36, and 48
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Secondary outcome [5]
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The Proportion of Subjects With a Change in a PSGA (Physician's Static Global Assessment) Score = 0 to 1
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Assessment method [5]
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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.
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Timepoint [5]
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Weeks 4, 8, 12, 24, 36, and 48
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Secondary outcome [6]
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Change in Subject's Global Assessment (SGA) of PsO
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Assessment method [6]
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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.
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Timepoint [6]
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Weeks 4, 8, 12, 24, 36, and 48
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Secondary outcome [7]
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Change in DLQI (Dermatology Life Quality Index)
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Assessment method [7]
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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.
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Timepoint [7]
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Weeks 12, 24, and 48
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Secondary outcome [8]
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Change in EuroQol 5-Dimension Health Status Questionnaire (EQ-5D)
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Assessment method [8]
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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).
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Timepoint [8]
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Weeks 12, 24, and 48
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Secondary outcome [9]
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Change in Health Assessment Questionnaire-Disability Index (HAQ-DI)
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Assessment method [9]
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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.
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Timepoint [9]
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Weeks 12, 24, and 48
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Secondary outcome [10]
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Change in Highly Sensitive C-reactive Protein (Hs-CRP; mg/L)
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Assessment method [10]
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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.
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Timepoint [10]
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Weeks 12, 24, and 48
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Secondary outcome [11]
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The Proportion of Subjects With a Durability of Response at Week 48
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Assessment method [11]
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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).
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Timepoint [11]
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Weeks 24, 36, and 48 when compared to baseline (Week 0).
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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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/06/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/05/2016
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Sample size
Target
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Accrual to date
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Final
521
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
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Recruitment hospital [1]
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Woden Dermatology Pty - Phillip
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Recruitment hospital [2]
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Dr S P Shumack (St George Dermatology and Skin Cancer Center) - Kogarah
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Recruitment hospital [3]
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Dr S P Shumack (Central Sydney Dermatology) - Sydney
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Recruitment hospital [4]
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North Eastern Health Specialists - Hectorville
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Recruitment hospital [5]
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Sinclair Dermatology - East Melbourne
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Recruitment postcode(s) [1]
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2606 - Phillip
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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2000 - Sydney
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Recruitment postcode(s) [4]
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5073 - Hectorville
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Recruitment postcode(s) [5]
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3002 - East Melbourne
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Recruitment outside Australia
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Arizona
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California
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Stellenbosch
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Worcester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Coherus Biosciences, Inc.
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Address
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Shire
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Ethics approval
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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).
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Trial website
https://clinicaltrials.gov/study/NCT02134210
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Barbara K Finck, M.D.
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Address
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Coherus Biosciences, Inc.
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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
Download to PDF