Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis

PHASE3RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

August 12, 2021

Primary Completion Date

February 23, 2027

Study Completion Date

May 15, 2029

Conditions
Ulcerative Colitis
Interventions
DRUG

tofacitinib

Open label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID.

Trial Locations (77)

1020

RECRUITING

Hôpital Universitaire Des Enfants Reine Fabiola, Brussels

1090

RECRUITING

Universitair Ziekenhuis Brussel, Brussels

1200

RECRUITING

Cliniques Universitaires Saint-Luc, Brussels

3000

RECRUITING

Universitaire Ziekenhuizen Leuven, Leuven

3052

ACTIVE_NOT_RECRUITING

The Royal Children's Hospital, Parkville

4032

RECRUITING

Debreceni Egyetem Klinikai Kozpont, Debrecen

6720

RECRUITING

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont, Szeged

10032

RECRUITING

Columbia University Irving Medical Center, New York

RECRUITING

CUIMC Research Pharmacy - Milstein Hospital (Pharmacy Only), New York

RECRUITING

Morgan Stanley Children's Hospital, CUIMC, New York

11040

ACTIVE_NOT_RECRUITING

Northwell Health - Cohen Children's Medical Center, New Hyde Park

11042

ACTIVE_NOT_RECRUITING

Northwell Health - Cohen Children's Medical Center, Lake Success

19104

ACTIVE_NOT_RECRUITING

Buerger Center for Advanced Pediatric Care, Philadelphia

ACTIVE_NOT_RECRUITING

Children's Hospital of Philadelphia, Philadelphia

19146

ACTIVE_NOT_RECRUITING

Roberts Center for Pediatric Research, Philadelphia

24127

RECRUITING

ASST Papa Giovanni XXIII Epatologia e Gastroenterologia Pediatrica e dei Trapianti, Bergamo

28009

RECRUITING

Hospital Infantil Universitario Niño Jesus, Madrid

30329

RECRUITING

Center for Advanced Pediatrics, Atlanta

RECRUITING

Children's Healthcare of Atlanta - Arthur M. Blank Hospital, Atlanta

33155

RECRUITING

Nicklaus Children's Hospital, Miami

33520

RECRUITING

Tampereen yliopistollinen sairaala, Tampere

40133

ACTIVE_NOT_RECRUITING

Azienda USL di Bologna - IRCCS ISNB - Programma Gastroenterologia Pediatrica, Bologna

45229

RECRUITING

Cincinnati Children's Hospital Medical Center, Cincinnati

69677

RECRUITING

CHU de Lyon - Hôpital Femme Mère Enfant, Bron

75015

RECRUITING

Hôpital Necker Enfants Malades, Paris

77030

RECRUITING

Texas Children's Hospital - RRO Regulatory (Administrative Offices - Regulatory Location), Houston

RECRUITING

Texas Children's Hospital, Houston

80131

RECRUITING

A.O.U. Federico II, Napoli

80337

RECRUITING

Dr. von Haunersches Kinderspital, LMU, Munich

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

94158

RECRUITING

University of California, San Francisco Benioff Children's Hospital, San Francisco

RECRUITING

University of California, San Francisco Pediatric Clinical Research Center (PCRC), San Francisco

98105

RECRUITING

Seattle Children's Hospital, Seattle

3436212

RECRUITING

Lady Davis Carmel Medical Center, Haifa

4920235

RECRUITING

Schneider Children's Medical Center of Israel, Petah Tikva

6423906

RECRUITING

Tel-Aviv Sourasky Medical Center, Tel Aviv

7033001

RECRUITING

Shamir Medical Center (Assaf Harofeh), Be’er Ya‘aqov

9103102

RECRUITING

Shaare Zedek Medical Center, Jerusalem

06032

ACTIVE_NOT_RECRUITING

Connecticut Children's Ambulatory Surgical Center, Farmington

ACTIVE_NOT_RECRUITING

Connecticut Children's Infusion Center, Farmington

06106

ACTIVE_NOT_RECRUITING

Connecticut Children's Medical Center, Hartford

02115

RECRUITING

Boston Children's Hospital, Boston

07960

RECRUITING

Atlantic Children's Health-Pediatric Gastroenterology & Nutrition, Morristown

RECRUITING

Goryeb Children's Hospital (Endoscopy only), Morristown

07962

RECRUITING

Atlantic Health System- Morristown Medical Center (Pharmacy), Morristown

T6G 1C9

RECRUITING

Stollery Children's Hospital University of Alberta, Edmonton

V6H 3N1

RECRUITING

British Columbia Children's Hospital, Vancouver

B3K 6R8

RECRUITING

IWK Health Centre, Halifax

N6A 5W9

RECRUITING

London Health Sciences Centre - Children's Hospital, London

M5G 1X8

ACTIVE_NOT_RECRUITING

The Hospital for Sick Children - Division of Gastroenterology, Hepatology and Nutrition, Toronto

H3T 1C5

RECRUITING

CHU Sainte-Justine, Montreal

00161

RECRUITING

Azienda Ospedaliero - Universitaria Policlinico Umberto I di Roma, Roma

474-8710

RECRUITING

Aichi Children's Health and Medical Center, Obu-shi

830-0011

RECRUITING

Kurume University Hospital, Kurume-shi

371-8511

RECRUITING

Gunma University Hospital, Maebashi

989-3126

RECRUITING

Miyagi Children's Hospital, Sendai

594-1101

RECRUITING

Osaka Women's and Children's Hospital, Izumi

569-8686

RECRUITING

Osaka Medical and Pharmaceutical University Hospital, Takatsuki-shi

330-8777

RECRUITING

Saitama Prefectural Children's Medical Center, Saitama-shi

329 0498

RECRUITING

Jichi Medical University Hospital, Shimotsuke

113-8431

RECRUITING

Juntendo University Hospital, Bunkyo-ku

157-8535

RECRUITING

National Center for Child Health and Development, Setagaya-ku

1081 HV

RECRUITING

Amsterdam UMC, location VUmc Boelelaan, Amsterdam

3015 GD

RECRUITING

Erasmus Medical Center - Sophia Children's Hospital, Rotterdam

93-338

RECRUITING

"Instytut Centrum Zdrowia Matki Polki", Lodz

35-302

RECRUITING

Korczowski Bartosz, Gabinet Lekarski, Rzeszów

04-501

RECRUITING

WIP Warsaw IBD Point Profesor Kierkus, Warsaw

04-730

RECRUITING

"Instytut Pomnik - Centrum Zdrowia Dziecka", Warsaw

50-369

RECRUITING

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu, Wroclaw

833 40

ACTIVE_NOT_RECRUITING

Narodny ustav detskych chorob, Bratislava

416 50

RECRUITING

Sahlgrenska Universitetssjukhuset, Gothenburg

118 83

RECRUITING

Sachsska Children's and Youth Hospital/South General Hospital, Stockholm

171 76

RECRUITING

Karolinska Universitetssjukhuset Barngastroenterologi, hepatologi och nutrition, Stockholm

SE5 9RS

RECRUITING

King's College Hospital NHS Foundation Trust, London

B4 6NH

RECRUITING

Birmingham Women's and Children's NHS Foundation Trust, Birmingham

EH16 4TJ

RECRUITING

NHS Lothian, Edinburgh

E1 1BB

RECRUITING

Bart's Health NHS Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT04624230 - Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | Biotech Hunter | Biotech Hunter