WHO ICTRP trial
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric…
CTRI/2022/03/040770 · Clinical Trials Registry India (CTRI) · Recruiting
Key facts
| Trial ID | CTRI/2022/03/040770 |
|---|---|
| Public title | A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With systemic juvenile idiopathic arthritis (sJIA) |
| Scientific title | Efficacy, safety, tolerability and pharmacokinetics of tofacitinib for treatment of systemic juvenile idiopathic arthritis (sJIA) with active systemic features in children and adolescent subjects |
| Primary sponsor | Pfizer Inc |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | Phase 3 |
| Countries | Argentina;Belgium;Brazil;Canada;Costa Rica;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Slovakia;South Africa;Spain;Sweden;Turkey;Ukraine;United Kingdom;United… |
| Conditions | Health Condition 1: M082- Juvenile rheumatoid arthritis withsystemic onset |
| Interventions | Intervention1: Tofacitinib: 5 mg BID oral, twice daily, tablet or solution In open-label phase: treatment with tofacitinib Treatment with investigational drug. Duration of therapy will be 12 to 40 Weeks Control Intervention1: Placebo: In… |
| Registration date | Mar 3, 2022 |
| Target size | 100 |
| Secondary IDs | 2017-002018-29;A3921165_Final_Protocol_Amendment5_21July2021;NCT03000439 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: