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/NCT01101100
Registration number
NCT01101100
Ethics application status
Date submitted
1/04/2010
Date registered
9/04/2010
Date last updated
30/07/2019
Titles & IDs
Public title
Study to Assess the Long-term Safety, Tolerability, and Efficacy of AMG 827 in Subjects With Psoriasis
Query!
Scientific title
A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects With Psoriasis
Query!
Secondary ID [1]
0
0
20090403
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
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 - AMG 827
Experimental: AMG 827 - AMG 827
Treatment: Drugs: AMG 827
210 mg SC or 140 mg SC
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Clear (0) or Clear/Almost Clear (0 or 1)
Query!
Assessment method [1]
0
0
Percentage of participants with a static physician's global assessment (sPGA) of clear (0) or clear/almost clear (0 or 1)
Query!
Timepoint [1]
0
0
264 weeks
Query!
Primary outcome [2]
0
0
Percent Change in Psoriasis Area and Severity Index (PASI)
Query!
Assessment method [2]
0
0
Mean percent change in Psoriasis Area and Severity Index (PASI). A decrease in PASI is an improvement.
Query!
Timepoint [2]
0
0
264 weeks
Query!
Eligibility
Key inclusion criteria
- Subject was randomized into Study 20090062 and completed the week 16 evaluation.
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
- Subject had any Serious Adverse Event (SAE) reported during Study 20090062 that was
considered possibly related to IP.
- Subject experienced an adverse event in Study 20090062 that, in the opinion of the
investigator, could cause extension of treatment to be detrimental to the subject.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
N/A
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
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2015
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
181
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Query!
Recruitment hospital [1]
0
0
Research Site - Kogarah
Query!
Recruitment hospital [2]
0
0
Research Site - Adelaide
Query!
Recruitment hospital [3]
0
0
Research Site - Parkville
Query!
Recruitment hospital [4]
0
0
Research Site - Prahran
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [3]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [4]
0
0
3181 - Prahran
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Georgia
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Illinois
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Missouri
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
New Mexico
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Texas
Query!
Country [6]
0
0
Canada
Query!
State/province [6]
0
0
Ontario
Query!
Country [7]
0
0
Canada
Query!
State/province [7]
0
0
Quebec
Query!
Country [8]
0
0
Denmark
Query!
State/province [8]
0
0
Aarhus
Query!
Country [9]
0
0
Denmark
Query!
State/province [9]
0
0
Hellerup
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Besançon
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Nice
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Toulouse Cedex 9
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bausch Health Americas, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study is an open-label extension of study 20090062 to evaluate extended subcutaneous
dosing.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01101100
Query!
Trial related presentations / publications
Papp K, Leonardi C, Menter A, Thompson EH, Milmont CE, Kricorian G, Nirula A, Klekotka P. Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment. J Am Acad Dermatol. 2014 Dec;71(6):1183-1190.e3. doi: 10.1016/j.jaad.2014.08.039. Epub 2014 Oct 11.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
MD
Query!
Address
0
0
Amgen
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/NCT01101100
Download to PDF