A Study to Assess Deucravacitinib Safety in Pregnancy
A legfontosabb adatok
- Hol
- La Jolla (Egyesült Államok)A helyszín megnézése
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat várandós nőket keres három csoportban: psoriasis deucravacitinib-kezeléssel, psoriasis más szisztémás kezeléssel, illetve psoriasis és autoimmun betegség nélkül.
- Nem
- Csak nők
- A betegség stádiuma
- Az első két csoportban psoriasis (PsO), lehetőség szerint az orvosi dokumentáció igazolja. A harmadik csoportban nincs psoriasis vagy más autoimmun betegség.
- Korábbi kezelés
- Első csoport: deucravacitinibet szedett, bármilyen adagban, a fogantatás előtti 2 naptól a terhesség végéig. Második csoport: kaphatott más szisztémás psoriasis-kezelést.
A részvétel fő kizáró okai
- Egy korábbi terhességével már részt vett ebben a vizsgálatban
- A felvétel előtt a terhesség már véget ért
- Metotrexát vagy szájon át szedett retinoid szedése (a psoriasis csoportokban)
- Másik szájon át szedett TYK2-gátló vagy JAK-gátló szedése
- A felvétel előtti diagnosztikai vizsgálat súlyos veleszületett fejlődési rendellenességet jelzett
Ez a vizsgálat csak várandós résztvevőket keres. A regiszter mondata, amelyen ez alapul: Currently pregnant during the enrollment period
Gépi kiolvasás: 2026. november 9.
Helyszínek itt: Egyesült Államok
- University of California San DiegoLa Jolla, Egyesült ÁllamokRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Bristol-Myers Squibb
- Azonosító
- NCT07017699
- A regiszteradat frissítve
- 2026. október 1.
- Eredeti leírás
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists [OTIS]) who were exposed to deucravacitinib.A teljes eredeti leírásKevesebb
The Deucravacitinib Pregnancy Exposure Study: A Prospective Observational Study of Deucravacitinib Safety in Pregnancy
The purpose of this study is to assess pregnancy and infant outcomes among pregnant participants enrolled in an established North American pregnancy registry (Organization of Teratology Information Specialists [OTIS]) who were exposed to deucravacitinib.
Bevonási feltételek: Cohort 1: Deucravacitinib-exposed cohort; Currently pregnant during the enrollment period; Diagnosed with psoriasis (PsO) validated by medical records when possible; Exposure to deucravacitinib for any number of days, at any dose, and at any time from 2 days prior to date of conception (DOC) to the end of pregnancy; Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants; Cohort 2: PsO Disease-matched unexposed comparator cohort; Currently pregnant during the enrollment period; Diagnosed with PsO validated by medical records when possible; May be exposed to systemic treatments for PsO; Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants; Cohort 3: Non-disease unexposed comparator cohort; Currently pregnant during the enrollment period; Agree to the conditions and requirements of the study including the interview schedule, release of medical records, and the dysmorphology examination of live born infants.
Kizáró feltételek: Pregnant women who have enrolled in this cohort study with a previous pregnancy; Women who do not have exposure to deucravacitinib anytime from 2 days prior to DOC to the end of pregnancy; Women who have exposure to another oral tyrosine kinase 2 (TYK2) inhibitor or any oral Janus kinase (JAK) inhibitor from within 5 half-lives of DOC to the end of pregnancy; Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment); Results of a diagnostic test are positive for an major congenital malformation(s) (MCM) prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM; Cohort 2: Disease-matched unexposed comparator cohort; Pregnant women who have enrolled in this cohort study with a previous pregnancy; Women who have exposure to deucravacitinib or any other oral TYK2 inhibitor except deucravacitinib, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy; Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment); Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM; Cohort 3: Non-disease unexposed comparator cohort; Pregnant women who have enrolled in this cohort study with a previous pregnancy; Women who have had exposure to deucravacitinib or any other oral TYK2 inhibitor, or any oral JAK inhibitor from within 5 half-lives of DOC to the end of pregnancy; Retrospective enrollment after the outcome of pregnancy is known (ie, the pregnancy has ended prior to enrollment); Results of a diagnostic test are positive for an MCM prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate an MCM; Women who are diagnosed with PsO, or any other autoimmune disease; Cohort 1: Deucravacitinib-exposed cohort; Pregnant women who have used deucravacitinib for an indication other than PsO; Women who have exposure to methotrexate or an oral retinoid; Women who have exposure to methotrexate or an oral retinoid; Women exposed to a known, possible, or suspected human teratogen during pregnancy as confirmed by the OTIS Research Center (see Appendix 3 for list of known, possible, and suspected human teratogens).