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

Ulcerative Colitis Clinical Trial

Official title:

OPEN-LABEL INDUCTION AND MAINTENANCE STUDY OF ORAL CP-690,550 (TOFACITINIB) IN CHILDREN WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04624230
• Other study ID #: A3921210
• Secondary ID: 2018-002378-30OV
• Status: Recruiting
• Phase: Phase 3
• Start date: August 12, 2021
• Est. completion date: December 21, 2026

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving 5 mg BID with the option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation criteria are met. The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The study Design is an open-label Phase 3 study that includes a screening period of up to 4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24-month extension phase for pediatric participants with moderately to severely active UC. Participants will have a follow-up visit 4 weeks after the last dose of study intervention and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 21, 2026
• Est. primary completion date: December 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

Inclusion Criteria:

• Evidence of a personally signed and dated informed consent document and assent document.
• Males and females 2 to less than18 years old and weighing at least 10 kg.
• Having a pathology report that confirms colonic inflammation consistent with UC with a clinical diagnosis of UC for at least 12 weeks prior to baseline, with biopsy report supporting the diagnosis of UC.
• Participants diagnosed with UC at age less than 6 years old, must have had testing and be negative for monogenic disorders associated with very early onset IBD.
• Moderately to severely active UC as defined (via screening colonoscopy) by a Mayo score of at least 6, with a rectal bleeding score of at least 1 and an endoscopic subscore of at least 2.
• Pediatric Ulcerative Colitis Activity Index (PUCAI) score greater or equal to 35 .
• No history of dysplasia or colon cancer.
• No evidence or history of untreated or inadequately treated active or latent infection with Mycobacterium Tuberculosis.
• For participants outside of the United States or the European Union: have had an inadequate response or been intolerant to at least one prior therapy as listed below

or have a medical contraindication to such therapies:

• Oral or intravenous (IV) corticosteroids;
• Azathioprine or 6-mercaptopurine;
• TNF inhibitors or anti integrin therapy.
• For participants in the United States and the European Union: have had an inadequate response or intolerance to TNF inhibitors.
• Stable doses of the following therapies for UC:
• Oral 5 Aminosalicyclic acids (ASA) or sulfasalazine
• Oral corticosteroids equivalent to prednisone at most 1 mg/kg up to a maximum of 20 mg/day or budesonide up to 9 mg/day.
• female participant is eligible if she is not pregnant or breastfeeding, If she is a woman of child bearing potential, she needs to be using a contraceptive method that is highly effective (with a failure rate of <1% per year).

Exclusion Criteria:

• Diagnosis of indeterminate colitis, isolated proctitis, microscopic colitis, infectious colitis, Crohn's disease, or clinical findings suggestive of Crohn's disease.
• History of symptomatic obstructive intestinal strictures or active ostomy, or history of colectomy, extensive small bowel resection ( greater than100 centimetres) or short bowel syndrome, or hospitalization for UC related reason(s) within 2 weeks of baseline visit.
• Any factors or clinical characteristics potentially related to the risk of venous thromboembolism that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Participants who have previously received tofacitinib or another Janus Kinase inhibitor.
• Vaccination or exposure to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, or who are expected to be vaccinated or to have household exposure to these vaccines during treatment or during the 6 weeks following discontinuation of study drug.
• Participants having received azathioprine, 6-mercaptopurine, methotrexate, thioguanine, infliximab, adalimumab, golimumab, ustekinumab, interferon, cyclosporine, mycophenolate, tacrolimus, IV or rectally administered corticosteroids, natalizumab, vedolizumab, other antiadhesion molecules, or investigational drugs during the specified time periods prior to baseline whereby they may still have pharmacokinetic and/or pharmacodynamic effect in the body of the participant.
• Previous treatment by leukocyte apheresis including selective lymphocyte, monocyte, or granulocyte apheresis, or plasma exchange within 6 months prior to baseline.
• Treatment by specified prohibited concomitant medications, including moderate to potent CYP3A inducers or inhibitors in the specified time periods prior to the first dose of study drug or are expected to receive any of these medications during the study period.
• Chronic and frequent use of antimotility agents for control of diarrhea (ie, diphenoxylate hydrochloride with atropine sulfate or loperamide).
• History of bowel surgery, including cholecystectomy within 6 months prior to baseline, history of appendectomy within 3 months prior to baseline, or significant trauma or major surgery within 4 weeks of screening visit are excluded.
• Participants with the following laboratory values at screening:
• Hemoglobin level lower than 9.0 g/Dl.
• Absolute white blood cell (WBC) count lower than 3000/mm3.
• Absolute neutrophil count lower than 1200/mm3.
• Absolute lymphocyte count lower than 750/mm3.
• Thrombocytopenia as defined by a platelet count lower than 100,000/mm3.
• Estimated bedside Schwartz Glomerular filtration rate (GFR) lower or equal to 40 mL/min/1.73 m2.
• Total bilirubin, aspartate aminostransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal.
• Positive stool examinations for enteric pathogens, pathogenic ova or parasites, or C. difficile toxin at screening.
• Participants infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
• History of more than one episode of HZ, a history of disseminated HZ or disseminated herpes simplex.
• History or current symptoms of any lymphoproliferative disorder (eg, Epstein Barr Virus (EBV) related lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of currently lymphatic disease).
• Clinically significant infections currently or within 3 months prior to baseline (eg, those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), a history of any infection requiring antimicrobial therapy within 2 weeks of baseline, or a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
• Any malignancies or with a history of malignancies, with the exception of adequately treated or excised nonmetastatic basal cell or squamous cell cancer of the skin.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are employees of the Sponsor, including their family members, directly involved in the conduct of the study.
• Participation in other studies involving investigational drug(s) within 2 months prior to study entry and/or during study participation.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Pregnant female participants; breastfeeding female participants; fertile female participants of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and through the telephone follow up visit.
• History of allergies, intolerance or hypersensitivity to lactose or tofacitinib, or any other excipients of the investigational medicinal products, including placebos.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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.

Locations

Country	Name	City	State
Australia	Women's and Children's Hospital, Women's and Children's Health Network Inc.	North Adelaide	South Australia
Australia	The Royal Children's Hospital	Parkville	Victoria
Belgium	Universitair Ziekenhuis Brussel	Brussel
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hôpital Universitaire Des Enfants Reine Fabiola	Brussels
Belgium	Universitaire Ziekenhuizen Leuven	Leuven	Vlaams Brabant
Canada	Stollery Children's Hospital University of Alberta	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	London Health Sciences Centre - Children's Hospital	London	Ontario
Canada	CHU Sainte-Justine	Montreal	Quebec
Canada	The Hospital for Sick Children - Division of Gastroenterology, Hepatology and Nutrition	Toronto	Ontario
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
Finland	Tampereen yliopistollinen sairaala	Tampere
France	CHU de Lyon - Hôpital Femme Mère Enfant	BRON Cedex
France	Hôpital Necker Enfants Malades	Paris
Germany	Dr. von Haunersches Kinderspital, LMU	Munich	Bavaria
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen	Hajdú-bihar
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Borsod- Abauj- Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz	Miskolc
Hungary	Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont	Szeged
Israel	Shamir Medical Center (Assaf Harofeh)	Be'er Ya'akov
Israel	Lady Davis Carmel Medical Center	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Schneider Children's Medical Center of Israel	Petah Tikva
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Italy	ASST Papa Giovanni XXIII Epatologia e Gastroenterologia Pediatrica e dei Trapianti	Bergamo	BG
Italy	Azienda USL di Bologna - IRCCS ISNB - Programma Gastroenterologia Pediatrica	Bologna
Italy	A.O.U. Federico II	Napoli	Naples
Italy	A.O.U. Policlinico Umberto I	Roma	RM
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	Osaka Women's and Children's Hospital	Izumi	Osaka
Japan	Kurume University Hospital	Kurume-shi	Fukuoka
Japan	Gunma University Hospital	Maebashi	Gunma
Japan	Aichi Children's Health and Medical Center	Obu-shi	Aichi
Japan	Saitama Prefectural Children's Medical Center	Saitama-shi	Saitama
Japan	Miyagi Children's Hospital	Sendai-shi	Miyagi
Japan	National Center for Child Health and Development	Setagaya-ku	Tokyo
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Osaka Medical and Pharmaceutical University Hospital	Takatsuki-shi	Osaka
Netherlands	Amsterdam UMC, location VUmc Boelelaan	Amsterdam
Netherlands	Erasmus Medical Center - Sophia Children's Hospital	Rotterdam
Poland	Szpital Uniwersytecki nr 1 im. dr. A. Jurasza w Bydgoszczy	Bydgoszcz
Poland	Instytut "Centrum Zdrowia Matki Polki"	Lodz
Poland	Korczowski Bartosz, Gabinet Lekarski	Rzeszow
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warsaw
Poland	Instytut "Pomnik - Centrum Zdrowia Dziecka"	Warszawa
Poland	WIP Warsaw IBD Point Profesor Kierkus	Warszawa
Poland	Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu	Wroclaw
Slovakia	Narodny ustav detskych chorob	Bratislava
Spain	Hospital Sant Joan de Déu	Esplugues de Llobregat	Barcelona
Spain	Hospital Infantil Universitario Niño Jesus	Madrid
Spain	Hospital Materno-Infantil de Málaga (Hospital Regional Universitario de Málaga)	Malaga	Málaga
Sweden	Sahlgrenska Sjukhuset, Drottning Silvias Barn- och Ungdomssjukhus	Göteborg
Sweden	Karolinska Universitetssjukhuset Barngastroenterologi, hepatologi och nutrition	Stockholm
Sweden	Sachsska Children's and Youth Hospital/South General Hospital	Stockholm
United Kingdom	Birmingham Women's and Children's NHS Foundation Trust	Birmingham	WEST Midlands
United Kingdom	Birmingham Women's and Children's NHS Foundation Trust	Birmingham	WEST Midlands
United Kingdom	NHS Lothian	Edinburgh
United Kingdom	Royal Hospital for Children	Glasgow
United Kingdom	Bart's Health NHS Trust	London
United Kingdom	Bart's Health NHS Trust	London
United Kingdom	King's College Hospital NHS Foundation Trust	London	Greater London
United Kingdom	Royal London Children's Hospital	London
United Kingdom	Royal London Children's Hospital	London
United States	Outpatient Pediatric Research Center Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Duke University Health System	Durham	North Carolina
United States	Connecticut Children's Ambulatory Surgical Center	Farmington	Connecticut
United States	Connecticut Children's Infusion Center	Farmington	Connecticut
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Texas Children's Hospital - Clinical Research Center	Houston	Texas
United States	Texas Children's Hospital - Feigin Tower (Administrative Offices - Research Administrative Offices)	Houston	Texas
United States	Texas Children's Hospital - RRO Regulatory (Administrative Offices - Regulatory Location)	Houston	Texas
United States	Texas Children's Hospital - Wallace Tower	Houston	Texas
United States	Texas Children's Hospital - West Tower	Houston	Texas
United States	Northwell Health - Cohen Children's Medical Center	Lake Success	New York
United States	Children's Hospital Los Angeles	Los Angeles	California
United States	Nicklaus Children's Hospital	Miami	Florida
United States	Children's Wisconsin	Milwaukee	Wisconsin
United States	Atlantic Children's Health-Pediatric Gastroenterology & Nutrition	Morristown	New Jersey
United States	Atlantic Health System- Morristown Medical Center (Pharmacy)	Morristown	New Jersey
United States	Goryeb Children's Hospital (Endoscopy only)	Morristown	New Jersey
United States	Northwell Health - Cohen Children's Medical Center	New Hyde Park	New York
United States	Columbia University Irving Medical Center	New York	New York
United States	CUIMC Research Pharmacy - Milstein Hospital (Pharmacy Only)	New York	New York
United States	Morgan Stanley Children's Hospital, CUIMC	New York	New York
United States	Mount Sinai Hospital (Investigational Drug Pharmacy)	New York	New York
United States	Mount Sinai Hospital Endoscopy Center (Endoscopy Only)	New York	New York
United States	Susan and Leonard Feinstein Inflammatory Bowel Disease Clinical Center at Mount Sinai	New York	New York
United States	Weill Cornell Medicine - New York Presbyterian Hospital	New York	New York
United States	Buerger Center for Advanced Pediatric Care	Philadelphia	Pennsylvania
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Roberts Center for Pediatric Research	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	University of California, San Francisco Benioff Children's Hospital	San Francisco	California
United States	University of California, San Francisco Pediatric Clinical Research Center (PCRC)	San Francisco	California
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Netherlands,  Poland,  Slovakia,  Spain,  Sweden,  United Kingdom, 

References & Publications (7)

Benchimol EI, Bernstein CN, Bitton A, Carroll MW, Singh H, Otley AR, Vutcovici M, El-Matary W, Nguyen GC, Griffiths AM, Mack DR, Jacobson K, Mojaverian N, Tanyingoh D, Cui Y, Nugent ZJ, Coulombe J, Targownik LE, Jones JL, Leddin D, Murthy SK, Kaplan GG. T — View Citation

Kelsen JR, Sullivan KE, Rabizadeh S, Singh N, Snapper S, Elkadri A, Grossman AB. North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition Position Paper on the Evaluation and Management for Patients With Very Early-onset Inflammato — View Citation

Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Bell — View Citation

Marcovitch L, Nissan A, Mack D, Otley A, Hussey S, Mclean B, Lewis M, Croft N, Barakat FM, Griffiths AM, Turner D. Item Generation and Reduction Toward Developing a Patient-reported Outcome for Pediatric Ulcerative Colitis (TUMMY-UC). J Pediatr Gastroente — View Citation

Otley A, Smith C, Nicholas D, Munk M, Avolio J, Sherman PM, Griffiths AM. The IMPACT questionnaire: a valid measure of health-related quality of life in pediatric inflammatory bowel disease. J Pediatr Gastroenterol Nutr. 2002 Oct;35(4):557-63. doi: 10.109 — View Citation

Taylor SJ, Whincup PH, Hindmarsh PC, Lampe F, Odoki K, Cook DG. Performance of a new pubertal self-assessment questionnaire: a preliminary study. Paediatr Perinat Epidemiol. 2001 Jan;15(1):88-94. doi: 10.1046/j.1365-3016.2001.00317.x. — View Citation

Turner D, Otley AR, Mack D, Hyams J, de Bruijne J, Uusoue K, Walters TD, Zachos M, Mamula P, Beaton DE, Steinhart AH, Griffiths AM. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission by central read Mayo score following 44 weeks in the maintenance phase.	Remission is defined by central endoscopy read Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.; The primary outcome Mayo score is the summation of 4 subscores as listed below : patient reported stool frequency (scored 0 to 3); patient reported rectal bleeding (scored 0 to 3); central read findings on endoscopy (scored 0 to 3); physician's global assessment (scored 0 to 3); The Mayo score has a scale from 0 to 12 points, with the lower score indicating lower ulcerative colitis (UC) disease activity.	Outcome measured at the end of the 44 weeks of the maintenance phase.
Secondary	Response by Mayo score	Response by Mayo score is defined by a decrease from baseline in Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.	Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44
Secondary	Remission by Mayo score	Remission by Mayo score with local and central endoscopy read (induction Week 8, induction Week 16), and with local endoscopy read only (maintenance week 44).	Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44
Secondary	Change from baseline in Mayo score.		Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44
Secondary	Response measured by Partial Mayo Score	Response is defined by a partial Mayo score decrease of 2 points or more from baseline. This score is based on the summation of the following subscores : stool frequency (scored 0 to 3); rectal bleeding (scored 0 to 3); physician global assessment (PGA) (scored 0 to 3); The partial Mayo score has a scale from 0 to 9, with the lower score indicating lower ulcerative colitis (UC) disease activity.	Outcome measured through study completion, an average of 3 and a half years
Secondary	Change from baseline in Partial Mayo score	Change in partial Mayo score. This score is the summation of 3 distinct dimensions as listed below : stool frequency (scored 0 to 3); rectal bleeding (scored 0 to 3); physician global assessment (PGA) (scored 0 to 3); The partial Mayo score has a scale from 0 to 9, with the lower score indicating lower ulcerative colitis (UC) disease activity.	Outcome measured through study completion, an average of 3 and a half years
Secondary	Response by PUCAI score	The Pediatric Ulcerative Colitis Activity Index (PUCAI) score is the summation of 6 dimensions that are all reported by the investigator. The PUCAI score varies from 0 to 85 points, with the lower score indicating lower ulcerative colitis (UC) disease activity. The 6 dimensions of the PUCAI score are as follows : abdominal pain; rectal bleeding; stool consistency of most stools; number of stools per 24 hours; nocturnal stools; activity level; Response is defined by a PUCAI score decrease of 20 points or more.	Outcome measured through study completion, an average of 3 and a half years
Secondary	Change from baseline in PUCAI score	The Pediatric Ulcerative Colitis Activity Index (PUCAI) score is the summation of 6 dimensions that are all reported by the investigator; abdominal pain; rectal bleeding; stool consistency of most stools; number of stools per 24 hours; nocturnal stools; activity level; The PUCAI score varies from 0 to 85 points, with the lower score indicating lower ulcerative colitis (UC) disease activity.	Outcome measured through study completion, an average of 3 and a half years
Secondary	Percentage of Participants Achieving Endoscopic Improvement at Week 8, 16, and 44	Endoscopic improvement is defined by Mayo endoscopic sub-score of 0 or 1. The Mayo endoscopic sub-score is used to assess ulcerative colitis activity, and ranges from 0 to 3, and is based on the findings during endoscopy. A lower score is indicative of a lower ulcerative colitis (UC) disease activity.	Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44
Secondary	Time to flare		Outcome measured from 2 to 4 months in the study, through study completion, an average of 3 and a half years
Secondary	Change from baseline in fecal calprotectin levels		Outcome measured through study completion, an average of 3 and a half years
Secondary	Change from baseline in serum high sensitivity C-Reactive Protein (hsCRP) levels		Outcome measured through study completion, an average of 3 and a half years
Secondary	Corticosteroid free remission by Partial Mayo Score	Remission is defined by a partial Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and rectal bleeding subscore of 0.; The subscores of the partial Mayo score are: stool frequency (scored 0 to 3); rectal bleeding (scored 0 to 3); physician global assessment (PGA) (scored 0 to 3)	Outcome measured through study completion, an average of 3 and a half years
Secondary	Average plasma concentration of tofacitinib (Cavg)		Outcome measured at baseline, induction Week 8, induction Week 16, maintenance Week 16, maintenance Week 44
Secondary	Evaluation of taste acceptability of tofacitinib oral solution, and acceptability of film coated tablet by choosing one of 5 choices	Taste acceptability will be assessed by asking the participant to select one of 5 choices which most adequately reflects the participant's response to taste. Age appropriate tools (using wording and/or graphic facial expressions) will be used to assess taste acceptability.	Outcome measured at induction week 2
Secondary	Peak (maximum) plasma concentration of tofacitinib (Cmax)		Outcome measured at baseline, induction Week 8, induction Week 16, maintenance Week 16, maintenance Week 44
Secondary	Percentage of Participants Achieving Endoscopic Remission at Week 8, 16, and 44	Endoscopic remission is defined by a Mayo endoscopic subscore of 0, out of a maximum of 3 points.; The Mayo endoscopic sub-score is used to assess ulcerative colitis activity, and ranges from 0 to 3, and is based on the findings during endoscopy. A lower score is indicative of a lower ulcerative colitis (UC) disease activity.	Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44
Secondary	Remission by PUCAI score	The Pediatric Ulcerative Colitis Activity Index (PUCAI) score is the summation of 6 dimensions that are all reported by the investigator. The PUCAI score varies from 0 to 85 points, with the lower score indicating lower ulcerative colitis (UC) disease activity. The 6 dimensions of the PUCAI score are as follows : abdominal pain; rectal bleeding; stool consistency of most stools; number of stools per 24 hours; nocturnal stools; activity level; Remission is defined by a PUCAI score of less than 10 points.	Outcome measured through study completion, an average of 3 and a half years

External Links

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