AMG 827 in Subjects With Psoriatic Arthritis

Status:	Terminated
Conditions:	Arthritis, Psoriasis
Therapuetic Areas:	Dermatology / Plastic Surgery, Rheumatology
Healthy:	No
Age Range:	18 - 75
Updated:	10/14/2017
Start Date:	October 2011
End Date:	September 2015

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.

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 have any drug in it) and neither the doctor nor the patient will know what
treatment is being given.

Inclusion Criteria:

- 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 Criteria:

- 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

We found this trial at

sites

Clinical Trial Facility in Rochester New York

Rochester, New York

from

Rochester, NY