Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01976364
Status:
COMPLETED
Last Update Posted:
2020-05-21
First Post:
2013-10-29
Brief Title:
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A LONG-TERM OPEN-LABEL EXTENSION STUDY OF TOFACITINIB CP-690550 FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPAL BALANCE
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OPAL BALANCE | OTHER | Alias Study Number | None |
| 2011-002169-39 | EUDRACT_NUMBER | None | None |