A Study of Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Must have a diagnosis of PsA by the Classification Criteria for Psoriatic Arthritis (CASPAR)
Has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline
Has an active psoriatic skin lesion
Is naïve to etanercept and any other biologic for the treatment for PsA or Psoriasis
Has no prior use of methotrexate for PsA
Has no history of tuberculosis
Has a negative test for tuberculosis, hepatitis B and C

Exclusion Criteria

Has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including Human Immunodeficiency Virus infection
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
Has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Eric Matteson, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Eric Matteson, M.D.

Closed for enrollment

More information

Publications

To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA. Read More on PubMed
To examine the efficacy of methotrexate monotherapy relative to etanercept monotherapy and the value of combining methotrexate and etanercept for the treatment of patients with psoriatic arthritis (PsA). Read More on PubMed
To evaluate the efficacy of etanercept and methotrexate as monotherapies and as combination therapy in subjects with active psoriatic arthritis (PsA). Read More on PubMed

Clinical Trials