Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

Amgen

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Placebo to Etanercept; Drug: Placebo to Methotrexate; Drug: Etanercept; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02376790

20130207

2014-004869-24 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.

Full description

The study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period.

At or after week 24, participants with an inadequate response could receive rescue therapy with etanercept plus methotrexate until the end of the treatment period.

Enrollment: 851 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
• Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.
• Subject has an active psoriatic skin lesion
• Subject is naïve to etanercept and any other biologic for the treatment for PsA or psoriasis.
• Subject has no prior use of methotrexate for PsA.
• Subject has no history of tuberculosis
• Subject has a negative test for tuberculosis, hepatitis B and C.

Exclusion Criteria:

• Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.
• Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product.
• Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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851 participants in 3 patient groups

Methotrexate Monotherapy

Active Comparator group

Description:

Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.

Treatment:

Drug: Methotrexate

Drug: Placebo to Etanercept

Etanercept Monotherapy

Experimental group

Description:

Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.

Treatment:

Drug: Placebo to Methotrexate

Drug: Etanercept

Methotrexate + Etanercept

Experimental group

Description:

Participants received etanercept 50 mg a week by subcutaneous injection plus oral methotrexate 20 mg weekly for 48 weeks.

Treatment:

Drug: Methotrexate

Drug: Etanercept