A study comparing the use of etanercept and methotrexate, used either alone or in combination for the treatment of Psoriatic Arthritis.
- Conditions
- Psoriatic arthritisMedDRA version: 19.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2014-004869-24-LV
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 840
•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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method