NCT01500551

Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

Detailed description

This is a Phase 2/3, long term, open-label, follow-up study. Subjects will have previously participated in qualifying/index JIA studies of tofacitinib. Those who have already completed such participation and enroll outside the 14 day window following completion of the End of Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to determine eligibility. A Baseline Visit will then occur within 28 days after the Screening Visit. For subjects who are completing participation in a qualifying study of tofacitinib and enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of the qualifying/index study can be combined with the Screening and Baseline Visits for this study. The subjects who enroll within the 14 day window following completion of the EOS Visit of the qualifying/index study will participate in a combined Screening and Baseline Visit for this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3 months, then every 3 months thereafter as long as the subject remains in the study. Approximately 340 participants are projected to enroll into this open label extension study after completing a qualifying/index study in the JIA program. For subjects who entered this study from the A3921103 and A3921104 qualifying/index studies, their participation in this study ends after the first marketing approval of tofacitinib for the treatment of polyarticular course Juvenile Idiopathic Arthritis (pJIA) in any country. This study will end once the last subject, and all other subjects, who entered from index study A3921165 have completed approximately 1 year in this study, or after the first marketing approval of tofacitinib for the treatment of systemic JIA, whichever comes first. The total duration of an individual subject's participation may vary depending upon when they enter the trial.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Tofacitinib	Tofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight for all subjects for all three index studies (A3921103, A3921104, and A3921165) 5 mg BID Dose Level: Body Weight (Dose in tablet \[mg BID\] or solution \[ml BID\]) 5 - \< 7 kg (2 mg or 2 ml) 7 - \< 10 kg (2.5 mg or 2.5 ml) 10 - \<15 kg (3 mg or 3 ml) 15 - \<25 kg (3.5 mg or 3.5 ml) 25 - \<40 kg (4 mg or 4 ml) \>=40 kg (5 mg or 5 ml) Oral solution (1 mg/mL concentration) will be used for subjects weighing \<40 kg. Oral tablets (5 mg) will be used for subjects weighing \>=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution. Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing.
DRUG	Tofacitinib	For subjects rolling over from study A3921103 and actively participating in this study at the time of Protocol Amendment 6 and receiving a dosage of tofacitinib in accordance with the dosing scheme specified in Protocol Amendment 5, investigators will have the option of maintaining the subject's current dosage regimen from index study A3921103 (if the desired clinical response has been attained with no safety concern) or adjusting the dosage regimen in accordance with the dosing scheme specified in this section.

Timeline

• Start date: 2013-03-18
• Primary completion: 2025-02-12
• Completion: 2025-02-12
• First posted: 2011-12-28
• Last updated: 2026-03-23
• Results posted: 2026-03-23

Locations

104 sites across 19 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Germany, India, Israel, Mexico, Poland, Russia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine, United Kingdom