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

This study is currently recruiting participants.
Verified by Amgen, April 2017

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 subjects with psoriatic arthritis.
To do this, etanercept alone will be compared to methotrexate alone or to combination etanercept and methotrexate.This study will last approximately 1 year (52 weeks) for an individual subject.
Subjects will be randomized into 1 of 3 groups. Subjects will have a 1 in 3 chance of receiving etanercept plus methotrexate, etanercept alone or methotrexate alone. Neither the subject nor the study doctor can choose the group to which the subject will be randomized into. Subjects will take one study medication by injection under their skin and a second medication taken by mouth. After the first 24 weeks of the study, if the doctor evaluates the subject and determines that their condition has not improved, the subject may qualify to receive etanercept plus methotrexate.


Condition Intervention Phase
Psoriatic Arthritis
Drug: Etanercept + Oral Methotrexate
Drug: Etanercept + Placebo for Methotrexate
Drug: Oral Methotrexate + Placebo for Etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind   (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Estimated Enrollment: 840
Study Start Date:2015 March DDDD Study Start Date Type: Actual

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

Arms Assigned Interventions
Active Comparator: Etanercept & Methotrexate Combo
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 20 mg weekly.
Drug: Etanercept + Oral Methotrexate
Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 20 mg weekly.
Other Name: Enbrel
Placebo Comparator: Etanercept Mono
Etanercept 50 mg weekly by subcutaneous injection plus oral placebo for methotrexate.
Drug: Etanercept + Placebo for Methotrexate
Etanercept 50 mg weekly by subcutaneous injection plus oral placebo for methotrexate.
Other Name: Enbrel
Placebo Comparator: Methotrexate Mono
Oral methotrexate 20 mg weekly plus placebo for etanercept.
Drug: Oral Methotrexate + Placebo for Etanercept
Oral methotrexate 20 mg weekly plus placebo for etanercept.
Other Name: Enbrel

Detailed Description:
This is a multicenter, randomized, double-blind controlled study to evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy, in subjects with PsA as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response and Minimal Disease Activity (MDA) at week 24.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. Approximately 840 subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment groups (280 per group): etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 20 mg weekly, etanercept 50 mg weekly by subcutaneous injection plus oral placebo for methotrexate, and oral methotrexate 20 mg weekly plus placebo for etanercept. Starting at week 24 visit, subjects who have an inadequate response will be provided rescue treatment of etanercept plus methotrexate for the remainder of the study.


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 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 orimmunodeficiency syndromes, including Human Immunodeficiency Virusinfection.
• Subject has any active infection (including chronic or localized infections) for
• infectives were indicated within 4 weeks prior to the first dose ofinvestigational product.
• Subject has a serious infection, defined as requiring hospitalization or intravenous
• infectives within 8 weeks prior to the first dose of investigational product.


Contacts and Locations

Contacts
Contact: Amgen Call Center 866-572-6436

 Show 139 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

http://www.amgentrials.com

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
Other Study ID Numbers: 20130207
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