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AMG 827 in Subjects With Psoriatic Arthritis
A Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study With an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects With Psoriatic Arthritis.
1 other identifier
interventional
168
2 countries
31
Brief Summary
The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Typical duration for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
August 27, 2020
CompletedAugust 27, 2020
August 1, 2020
11 months
August 18, 2011
November 8, 2016
August 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an American College of Rheumatology (ACR) 20%
To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20% response at week 12. ACR20 responders are subjects with 20% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.
Baseline to week 12
Secondary Outcomes (4)
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50
Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70
Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI)
Baseline to week 12
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Disease Activity Score With a 28 Joint Count (DAS 28)
Baseline to week 12
Study Arms (4)
AMG 827 140
EXPERIMENTAL140 mg AMG 827
Placebo SC
PLACEBO COMPARATORPlacebo
AMG 827 280
EXPERIMENTAL280 mg AMG 827
AMG 827 210
EXPERIMENTALAMG 827 SC 210 mg
Interventions
Eligibility Criteria
You may qualify if:
- Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months
- Subject has ≥ 3 tender and ≥ 3 swollen joints
You may not qualify if:
- Subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic)
- Significant concurrent medical conditions
- Pregnant or breast feeding
- Significant Laboratory abnormalities
- Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days
- Use of anti-TNF therapy within 2 months
- Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months
- Prior use of rituximab
- Prior use of anti-IL-17 biologic therapy, including AMG 827
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Research Site
Peoria, Arizona, 85381, United States
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
Tucson, Arizona, 85711, United States
Research Site
Hemet, California, 92543, United States
Research Site
Huntington Beach, California, 92646, United States
Research Site
La Jolla, California, 92037, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
Palm Desert, California, 92260, United States
Research Site
Palo Alto, California, 94304, United States
Research Site
Victorville, California, 92395, United States
Research Site
Sarasota, Florida, 34239, United States
Research Site
Boise, Idaho, 83702, United States
Research Site
Lexington, Kentucky, 40504, United States
Research Site
Baton Rouge, Louisiana, 70809, United States
Research Site
Frederick, Maryland, 21702, United States
Research Site
Grand Rapids, Michigan, 49546, United States
Research Site
Lansing, Michigan, 48910, United States
Research Site
Lebanon, New Hampshire, 03756, United States
Research Site
Rochester, New York, 14642, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Duncansville, Pennsylvania, 16635, United States
Research Site
Seattle, Washington, 98122, United States
Research Site
Victoria, British Columbia, V8P 5P6, Canada
Research Site
Winnipeg, Manitoba, R3A 1M3, Canada
Research Site
St. John's, Newfoundland and Labrador, A1A 5E8, Canada
Research Site
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Research Site
Newmarket, Ontario, L3Y 3R7, Canada
Research Site
Ottawa, Ontario, K1H 8L6, Canada
Research Site
Québec, Quebec, G1V 3M7, Canada
Research Site
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Research Site
Québec, G1W 4R4, Canada
Related Publications (2)
Mease PJ, Genovese MC, Greenwald MW, Ritchlin CT, Beaulieu AD, Deodhar A, Newmark R, Feng J, Erondu N, Nirula A. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014 Jun 12;370(24):2295-306. doi: 10.1056/NEJMoa1315231.
PMID: 24918373BACKGROUNDMease PJ, Genovese MC, Mutebi A, Viswanathan HN, Chau D, Feng J, Erondu N, Nirula A. Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis. J Rheumatol. 2016 Feb;43(2):343-9. doi: 10.3899/jrheum.150182. Epub 2016 Jan 15.
PMID: 26773108DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
MD
Amgen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2011
First Posted
January 25, 2012
Study Start
October 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2015
Last Updated
August 27, 2020
Results First Posted
August 27, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will share