Status:
TERMINATED
AMG 827 in Subjects With Psoriatic Arthritis
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis
Detailed Description
The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid that does not ha...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT01516957
Start Date
October 1 2011
End Date
September 1 2015
Last Update
August 27 2020
Active Locations (31)
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1
Research Site
Peoria, Arizona, United States, 85381
2
Research Site
Scottsdale, Arizona, United States, 85258
3
Research Site
Tucson, Arizona, United States, 85711
4
Research Site
Hemet, California, United States, 92543