A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication.
This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.
Inclusion Criteria:
Exclusion Criteria:
Sub-study Inclusion Criteria:
Sub-study Exclusion Criteria:
-Subjects who are receiving methotrexate by a route other than oral
Fullerton, California 92835, United States
Stanford, California 94305, United States
Palm Harbour, Florida 34684, United States
Plantation, Florida 33324, United States
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Juiz de Fora, Minas Gerais 36010-570, Brazil
Porto Alegre, Rio Grande do Sul 90035-903, Brazil
Frankfurt am Main, 60598, Germany
Homburg, 66421, Germany
Budapest, 1027, Hungary
Budapest, 1062, Hungary
Mérida, Yucatán 97130, Mexico
Bialystok, 15-002, Poland
Elblag, 82-300, Poland
Elblag, 82-300, Poland
Grodzisk Mazowiecki, 05-825, Poland
Torun, 87-100, Poland
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Moscow, 119049, Russia
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Yaroslavl, 150003, Russia
Yaroslavl, 150003, Russia
Goodmayes, Essex IG3 8YB, United Kingdom