AMG 827 in Subjects With Psoriatic Arthritis

NCT ID: NCT01516957

Last Updated: 2020-08-27

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-09-30

Brief Summary

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The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

Detailed Description

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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.

Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AMG 827 140

140 mg AMG 827

Group Type EXPERIMENTAL

AMG 827 140

Intervention Type DRUG

140 mg AMG 827 SC (subcutaneous)

Placebo SC

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo SC (subcutaneous)

AMG 827 280

280 mg AMG 827

Group Type EXPERIMENTAL

AMG 827 280

Intervention Type DRUG

280 mg AMG 827 SC (subcutaneous)

AMG 827 210

AMG 827 SC 210 mg

Group Type EXPERIMENTAL

AMG 827 210

Intervention Type DRUG

210 mg AMG 827 SC (subcutaneous)

Interventions

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AMG 827 140

140 mg AMG 827 SC (subcutaneous)

Intervention Type DRUG

Placebo

Placebo SC (subcutaneous)

Intervention Type DRUG

AMG 827 280

280 mg AMG 827 SC (subcutaneous)

Intervention Type DRUG

AMG 827 210

210 mg AMG 827 SC (subcutaneous)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Peoria, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Hemet, California, United States

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Huntington Beach, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Palm Desert, California, United States

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Palo Alto, California, United States

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Victorville, California, United States

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Sarasota, Florida, United States

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Boise, Idaho, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Frederick, Maryland, United States

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Grand Rapids, Michigan, United States

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Lansing, Michigan, United States

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Lebanon, New Hampshire, United States

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Rochester, New York, United States

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Portland, Oregon, United States

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Duncansville, Pennsylvania, United States

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Seattle, Washington, United States

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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St. John's, Newfoundland and Labrador, Canada

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St. John's, Newfoundland and Labrador, Canada

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Newmarket, Ontario, Canada

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Ottawa, Ontario, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Québec, , Canada

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Countries

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United States Canada

References

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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.

Reference Type BACKGROUND
PMID: 24918373 (View on PubMed)

Mease 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.

Reference Type DERIVED
PMID: 26773108 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101227

Identifier Type: -

Identifier Source: org_study_id

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