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

Conditions

• Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex

ALL

Age

2 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Tofacitinib — DRUG
  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.
• Tofacitinib — DRUG
  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.

Study Details

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

Key Dates

Start date

Mar 18, 2013

Status verified

Mar 2026

Primary completion

Feb 12, 2025

Completion

Feb 12, 2025

Study Design

Enrollment

302 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Tofacitinib
  All patients will be in tofacitinib treatment group.

Primary Outcome Measure

Number of Participants With Laboratory Test Abnormalities [ Time Frame: During study treatment (maximum up to 118 months) ]

Locations (43)

Related coverage on Hipa.ai

• Tofacitinib Long-Term Safety in JIA: Lab Abnormalities, TEAEs Reported
  Tofacitinib · Mar 23, 2026 · ClinicalTrials.gov

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