AMG 827 in Subjects With Psoriatic Arthritis

Bausch Health

Status and phase: Terminated; Phase 2

Conditions: Psoriatic Arthritis

Treatments: Drug: AMG 827 280; Drug: AMG 827 210; Drug: Placebo; Drug: AMG 827 140

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516957

20101227

Details and patient eligibility

About

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

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

Enrollment: 168 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 4 patient groups, including a placebo group

AMG 827 140

Experimental group

Description:

140 mg AMG 827

Treatment:

Drug: AMG 827 140

Placebo SC

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

AMG 827 280

Experimental group

Description:

280 mg AMG 827

Treatment:

Drug: AMG 827 280

AMG 827 210

Experimental group

Description:

AMG 827 SC 210 mg

Treatment:

Drug: AMG 827 210