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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01970488
Registration number
NCT01970488
Ethics application status
Date submitted
23/10/2013
Date registered
28/10/2013
Date last updated
3/04/2019
Titles & IDs
Public title
Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis
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Scientific title
A Phase 3, Multicenter, Randomized, Double-blind Study Evaluating the Efficacy and Safety of ABP 501 Compared With Adalimumab in Subjects With Moderate to Severe Plaque Psoriasis
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Secondary ID [1]
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2013-000537-12
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Secondary ID [2]
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20120263
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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:
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
Other interventions - Adalimumab
Other interventions - ABP 501
Experimental: ABP 501 - Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48.
Active Comparator: Adalimumab - Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16.
At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48.
Other interventions: Adalimumab
Administered by subcutaneous injection
Other interventions: ABP 501
Administered by subcutaneous injection
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Intervention code [1]
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Other interventions
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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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Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16
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Assessment method [1]
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The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline was calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [1]
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Percentage of Participants With a PASI 75 Response at Week 16
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Assessment method [1]
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A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score. The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
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Timepoint [1]
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Baseline and Week 16
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Secondary outcome [2]
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Percentage of Participants With a PASI 75 Response at Week 32
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Assessment method [2]
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A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
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Timepoint [2]
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Baseline and week 32
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Secondary outcome [3]
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Percentage of Participants With a PASI 75 Response at Week 50
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Assessment method [3]
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A PASI 75 response is a 75% or greater improvement (reduction) from baseline in PASI score.
The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
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Timepoint [3]
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Baseline and week 50
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Secondary outcome [4]
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Percent Improvement From Baseline in PASI at Week 32
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Assessment method [4]
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The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
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Timepoint [4]
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Baseline and week 32
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Secondary outcome [5]
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Percent Improvement From Baseline in PASI at Week 50
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Assessment method [5]
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The PASI measures the average redness (erythema), thickness (induration), and scaliness (each graded on a 0 to 4 scale) of psoriasis lesions, weighted by the area of involvement in the four main body areas (i.e., head and neck, trunk, upper extremities, and lower extremities). PASI scores can range from 0.0 to 72.0, with higher scores indicating greater severity and/or more extensive psoriasis.
Percent improvement from baseline is calculated as (value at baseline - value at post-baseline visit) × 100 / (value at baseline).
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Timepoint [5]
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Baseline and week 50
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Secondary outcome [6]
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Percentage of Participants With a Static Physician's Global Assessment (sPGA) Response at Week 16
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Assessment method [6]
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The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
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Timepoint [6]
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Week 16
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Secondary outcome [7]
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Percentage of Participants With a sPGA Response at Week 32
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Assessment method [7]
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The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
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Timepoint [7]
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Week 32
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Secondary outcome [8]
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Percentage of Participants With a sPGA Response at Week 50
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Assessment method [8]
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The sPGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) used to measure the severity of disease (induration, scaling, and erythema). A sPGA response is defined as a sPGA value of clear (score 0) or almost clear (score 1).
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Timepoint [8]
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Week 50
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Secondary outcome [9]
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Change From Baseline in the Percentage of Body Surface Area (BSA) Involved With Psoriasis at Week 16
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Assessment method [9]
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A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from baseline (negative value) indicates improvement.
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Timepoint [9]
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Baseline and Week 16
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Secondary outcome [10]
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Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 32
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Assessment method [10]
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A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement.
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Timepoint [10]
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Baseline and week 32
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Secondary outcome [11]
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Change From Baseline in the Percentage of BSA Involved With Psoriasis at Week 50
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Assessment method [11]
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A measurement of psoriasis involvement, given as the physician's assessment of the percentage of the participant's total body surface area (BSA) involved with psoriasis. The percent of BSA affected was estimated by assuming that the subject's palm, excluding the fingers and thumb, represented roughly 1% of the body's surface.
Change from baseline is calculated as (value at post-baseline visit - value at baseline).
A decrease from Baseline (negative value) indicates improvement.
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Timepoint [11]
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Baseline and week 50
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Secondary outcome [12]
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Number of Participants With Adverse Events
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Assessment method [12]
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The Investigator assessed whether each adverse event (AE) was possibly related to the investigational product. AEs were graded for severity according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03.
A serious AE is defined as an AE that meets at least 1 of the following serious criteria:
fatal
life threatening
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
congenital anomaly/birth defect
other medically important serious event. Results are reported from Day 1 to week 16 for the Part 1 ABP 501 and Adalimumab groups, and from post week 16 to the end of study (week 52) for the Part 2 ABP 501/ABP 501, Adalimumab/Adalimumab and Adalimumab/ABP 501 groups.
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Timepoint [12]
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From first dose of study drug until 28 days after the last dose. Treatment was for 16 weeks in Part 1 and 32 weeks in Part 2.
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Secondary outcome [13]
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Percentage of Participants Developing Antibodies to ABP 501 or Adalimumab
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Assessment method [13]
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Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay).
Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.
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Timepoint [13]
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For 16 weeks in Part 1 and for 52 weeks for participants who were re-randomized in Part 2.
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. Men or women = 18 and = 75 years of age at time of screening
2. Stable moderate to severe plaque psoriasis for at least 6 months before baseline
3. Moderate to severe psoriasis defined at screening and baseline by:
Body surface area (BSA) affected by plaque psoriasis of 10% or greater, and PASI score
of 12 or greater, and static physician's global assessment score of 3 or greater
4. No known history of active tuberculosis
5. Subject is a candidate for systemic therapy or phototherapy procedures
6. Previous failure, inadequate response, intolerance, or contraindication to at least 1
conventional anti-psoriatic systemic therapy
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Minimum age
18
Years
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Maximum age
75
Years
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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
1. Forms of psoriasis or other skin conditions at the time of the screening visit (eg,
eczema)
2. Ongoing use of prohibited treatments
3. Prior use of 2 or more biologics for treatment of psoriasis
4. Previous receipt of adalimumab or a biosimilar of adalimumab
Other Inclusion/Exclusion criteria may apply
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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
18/10/2013
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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
18/03/2015
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Sample size
Target
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Accrual to date
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Final
350
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Research Site - Saint Leonards
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Newfoundland and Labrador
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Country [2]
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Hungary
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State/province [2]
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Szabolcs-szatmar-bereg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this research study is to compare the efficacy and safety of ABP 501 and
adalimumab (HUMIRA®) in adults with plaque psoriasis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01970488
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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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MD
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Address
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Amgen
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01970488
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