Status:
COMPLETED
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
Lead Sponsor:
Pfizer
Conditions:
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone s...
Eligibility Criteria
Inclusion
- Males or females, aged \>= 18 years at time of consent.
- Have a diagnosis of Psoriatic arthritis (PsA) of \>= 6 months
- Meet the Classification Criteria of PsA (CASPAR) at time of screening
- Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
- Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
- Must not have taken a biologic Tumour Necrosis Factor Inhibitor
- Must have 3 or more swollen joints AND 3 or more tender joints
- Must have active psoriasis skin lesions
Exclusion
- Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
- Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
- New York Heart Association Class III and IV congestive heart failure
- History of hypersensitivity or infusion reaction to biologic agents
- Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
Key Trial Info
Start Date :
January 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2015
Estimated Enrollment :
422 Patients enrolled
Trial Details
Trial ID
NCT01877668
Start Date
January 20 2014
End Date
December 18 2015
Last Update
July 6 2017
Active Locations (123)
Enter a location and click search to find clinical trials sorted by distance.
1
Rheumatology Associates, PC
Birmingham, Alabama, United States, 35205
2
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States, 35801
3
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, United States, 85306
4
Medvin Clinical Research
Covina, California, United States, 91723