Clinical Trial Summary : 20130207
Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis FDA Regulated: Yes

This study has been completed.
Verified by Amgen, March 2019

Sponsored by: Amgen
Information provided by: Amgen

Purpose

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.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Etanercept
Drug: Methotrexate
Drug: Placebo to Etanercept
Drug: Placebo to Methotrexate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
No Masking: false
Official Title: A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis


Further study details as provided by Amgen

Primary Outcome Measures:
  • Efficacy as measured by American College of Rheumatology (ACR) 20 response. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.

Secondary Outcome Measures:
  • Minimal Disease Activity (MDA) response of arthritis activity. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.

  • Minimal Disease Activity (MDA) response for measures of non-arthritic PSA disease activity. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.

  • Minimal Disease Activity (MDA) response of patient reported outcomes. [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.

Enrollment: 851
Study Start Date:2015 March DDDD Study Start Date Type: Actual

Study Completion Date: July 2018
Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Methotrexate Monotherapy
Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
Drug: Methotrexate
Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.
Drug: Placebo to Etanercept
Placebo to etanercept was administered by subcutaneous injection once a week.
Experimental: Etanercept Monotherapy
Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
Drug: Etanercept
Etanercept was administered by subcutaneous injection once a week
Other Name: Enbrel
Drug: Placebo to Methotrexate
Placebo to methotrexate capsules taken orally once a week.
Experimental: Methotrexate + Etanercept
Participants received etanercept 50 mg a week by subcutaneous injection plus oral methotrexate 20 mg weekly for 48 weeks.
Drug: Etanercept
Etanercept was administered by subcutaneous injection once a week
Other Name: Enbrel
Drug: Methotrexate
Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.

Detailed 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.


Eligibility

Ages Eligible for Study:  18 Years and older
Genders Eligible for Study:  Both
Gender Based: 
Gender Eligibility Description: 
Accepts Healthy Volunteers:  No

Criteria

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.


Contacts and Locations

Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

 Show 140 Study Locations

Sponsors and Collaborators
Amgen
Oversight
Is FDA Regulated Intervention: Yes
U.S. FDA IND/IDE Study: Yes
Section 801 Trial: Yes
Unapproved/Uncleared Device: No

Investigators
Study Director: MD   Amgen

More Information
Responsible Party: Global Development Leader, Amgen Inc.
Other Study ID Numbers: 20130207, 2014-004869-24
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Bulgarian Drug Agency
Czech Republic: State Institute for Drug Control
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Latvia: State Agency of Medicines
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Mexico: Federal Commission for Protection Against Health Risks
U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Post Prior to Approval/Clearance
Pediatric Postmarket Surveillance
Product Exported From U.S.

Keywords provided by Amgen:

Psoriatic Arthritis
Arthritis, Psoriasis
Etanercept
Enbrel
Methotrexate
Minimal Disease Activity