Psoriatic arthritis MedDRA version: 19.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 689 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 151
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy, in subjects with psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology 20 response at week 24.;Secondary Objective: To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy as measured by the proportion of subjects achieving Minimal Disease Activity. To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy on the following: •Other measures of arthritis activity •Measures of non-arthritic psoriatic arthritis disease activity •Key patient reported outcomes related to physical function and quality of life;Primary end point(s): American College of Rheumatology (ACR 20) response at week 24;Timepoint(s) of evaluation of this end point: ACR 20 response at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy on the following: •Other measures of arthritis activity •Measures of non-arthritic PsA disease activity •Key patient reported outcomes (PRO) related to physical function and quality of life ;Timepoint(s) of evaluation of this end point: • Minimal Disease Activity (MDA) response of arthritis activity at week 24 •Minimal Disease Activity (MDA) response for measures of non-arthritic PSA disease activity at week 24 •Minimal Disease Activity (MDA) response of patient reported outcomes at week 24. | — |
Countries
Argentina, Bulgaria, Canada, Chile, Czech Republic, France, Greece, Hungary, Latvia, Mexico, Poland, Portugal, Russian Federation, South Africa, Spain, United States
Contacts
Public ContactMedical Information
Amgen (EUROPE) GmbH
Outcome results
None listed