WHO ICTRP trial
EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT…
NL-OMON51984 · Overview of Medical Research in the Netherlands (NL-OMON)
Key facts
| Trial ID | NL-OMON51984 |
|---|---|
| Public 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 |
| 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 - A3921165 |
| Primary sponsor | Syneos Health Netherlands B.V |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Study type | Interventional |
| Phase | 3 |
| Countries | Argentina;Belgium;Brazil;Canada;China;Costa Rica;Germany;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation ;Slovakia;South Africa;Spain;Sweden;Turkey;Ukraine;United… |
| Conditions | juvenile rheumatoid arthritis Still's disease;10003816;10023213;juvenile rheumatoid arthritis;Still's disease |
| Interventions | Open-label phase: All subjects <40 kg will receive tofacitinib 5 mg BID oral tablets, and all subjects <40 kg will receive a weight-based lower dose of tofacitinib oral solution (1 mg/mL) BID. Each dose must be taken two times per day… |
| Registration date | May 19, 2022 |
| Target size | 2 |
| Secondary IDs | 2017-002018-29;NL75258.041.20 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: