Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
Status: | Active, not recruiting |
---|---|
Conditions: | Arthritis, Psoriasis |
Therapuetic Areas: | Dermatology / Plastic Surgery, Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/24/2019 |
Start Date: | February 17, 2014 |
End Date: | July 11, 2019 |
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.
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:
- Previous participation in qualifying PsA study involving tofacitinib
Exclusion Criteria:
- Time from End of Study visit of qualifying study is >3 months.
- Pregnant female, breastfeeding female or female of childbearing potential unwilling or
unable to use highly effective birth control for duration of study and one ovulatory
cycle thereafter.
Sub-study Inclusion Criteria:
- Subjects who have completed at least 24 months of treatment with tofacitinib in the
extension study
- Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)
Sub-study Exclusion Criteria:
-Subjects who are receiving methotrexate by a route other than oral
We found this trial at
42
sites
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Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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