Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis (OPAL BALANCE)

Pfizer

Status and phase

Completed

Phase 3

Conditions

Arthritis, Psoriatic

Treatments

Drug: Tofacitinib

Drug: Methotrexate

Drug: Placebo Methotrexate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01976364

2011-002169-39 (EudraCT Number)

A3921092

OPAL BALANCE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

686 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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