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NCT03000439 · ClinicalTrials.gov registry record · Phase 3
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT03000439: Completed Phase 3 study, sponsored by Pfizer.
NCT03000439 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03000439, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. An interim analysis for efficacy and futility will be conducted when at least 20 flares have been observed. If either criterion is met, the study will be stopped. If neither criterion is met, the study will continue until the requisite number of flares are observed as determined by the number of flares included in the interim analysis and a statistical penalty for conducting the interim analysis.
Primary Outcome
Time to the disease flare=the number of days from randomization to flare in the DB phase and calculated as date of disease flare minus (-) date of randomization plus (+) 1. sJIA Flare=as at least one of the following criteria: Recurrence of fever \>38 degree Celsius (C)/100.4 degree Fahrenheit (F) on 2 or more consecutive days) was considered due to SJIA activity. Worsening of 30 percent (%) or more in three or more of the six variables included: Number of joints with active arthritis and limite
Interventions
- DRUG In open-label phase: treatment with tofacitinib
- DRUG In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2024-03-27 |
| Phase | Phase 3 |
What the finished NCT03000439 record still lists
NCT03000439 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which In open-label phase: treatment with tofacitinib is the first listed.
NCT03000439 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03000439 about?
NCT03000439 is a clinical study titled "A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA". A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once ...
What is the current status of trial NCT03000439?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2018-05-10. Estimated completion is 2024-03-27.
What interventions are being tested in trial NCT03000439?
The interventions under investigation include: In open-label phase: treatment with tofacitinib (DRUG), In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio (DRUG).
Who is sponsoring clinical trial NCT03000439?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03000439's enrollment target sits among peer trials
100 1681st of 2000 higher than 288 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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