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Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

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ClinicalTrials.gov Identifier: NCT02376790
Recruitment Status : Active, not recruiting
First Posted : March 3, 2015
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

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 or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Etanercept + Oral Methotrexate Drug: Etanercept + Placebo for Methotrexate Drug: Oral Methotrexate + Placebo for Etanercept Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 851 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : March 3, 2015
Primary Completion Date : January 9, 2018
Estimated Study Completion Date : July 6, 2018


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Efficacy as measured by American College of Rheumatology (ACR) 20 response. [ Time Frame: Week 24 ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.


Secondary Outcome Measures :
  1. Minimal Disease Activity (MDA) response of arthritis activity. [ Time Frame: Week 24 ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.

  2. Minimal Disease Activity (MDA) response for measures of non-arthritic PSA disease activity. [ Time Frame: Week 24 ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.

  3. Minimal Disease Activity (MDA) response of patient reported outcomes. [ Time Frame: Week 24 ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.


Other Outcome Measures:
  1. Adverse Events (AEs) [ Time Frame: 30 days after last dose of IP ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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 or immunodeficiency syndromes, including Human Immunodeficiency Virus 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376790


  Show 138 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02376790     History of Changes
Other Study ID Numbers: 20130207
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Keywords provided by Amgen:
Psoriatic Arthritis
Arthritis, Psoriasis
Etanercept
Enbrel
Methotrexate
Minimal Disease Activity

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Etanercept
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal