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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 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 100 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03000439
The ClinicalTrials.gov registry entry for NCT03000439 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which In open-label phase: treatment with tofacitinib is the first listed.
NCT03000439 reports 0 study locations.
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.
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