Back to Search Results
Study Complete
Sponsor ID
20130207

Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

Sponsor ID
20130207
Clinicaltrials.gov ID
NCT02376790
EUCTIS ID
N/A
EudraCT ID
2014-004869-24
Contact Us

Study Details

The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.

Additional Study Details

Phase
Phase 3
Product
etanercept
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
851
Additional Study Details

Protocol Summary

Primary Outcome Measures

Efficacy as measured by American College of Rheumatology (ACR) 20 response.

Timeframe: Week 24

Secondary Outcome Measures

Minimal Disease Activity (MDA) response of arthritis activity.

Timeframe: Week 24

Minimal Disease Activity (MDA) response for measures of non-arthritic PSA disease activity.

Timeframe: Week 24

Minimal Disease Activity (MDA) response of patient reported outcomes.

Timeframe: Week 24

Study Documents

Plain Language Summary of Results
Available Language(s): English, Bulgarian, Czech, French (Canadian), French, Greek, Hungarian, Latvian, Polish, Portuguese, Russian, Spanish (Argentina), Spanish (Chile), Spanish (Mexico), Spanish, English (UK), Afrikaans
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Quebec, QC, Canada, G1V 3M7
Status
Recruiting
Location
Research Site
Aventura, FL, United States, 33180
Status
Recruiting
Location
Research Site
Charlotte, NC, United States, 28204
Status
Recruiting
Location
Research Site
Duncansville, PA, United States, 16635
Status
Recruiting
Location
Research Site
Clearwater, FL, United States, 33765
Status
Recruiting
Location
Research Site
Lansing, MI, United States, 48910
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18+ years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Mar 2015 - Jan 2018
    Inclusion and Exclusion Criteria
    Key Inclusion Criteria: - Subject must have a diagnosis of psoriatic arthritis (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 (HIV) 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.