At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)
In Brief
A Phase 3 clinical trial evaluating Tofacitinib for Juvenile Idiopathic Arthritis. Completed, enrolled 302 participants across 104 sites in 19 countries.
Detailed Summary
Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.
Study Details
Timeline
Interventions
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.
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.