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Ulcerative ColitisPhase 3NCT04624230

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

A Phase 3 study testing tofacitinib in people with Ulcerative Colitis, run by Pfizer at 69 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
tofacitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
69 sitesin 16 countries
Study dates
12 Aug 2021to 6 Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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 .
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

69 sites in 16 countries.

69 sites in 16 countries

United States19 sites

  • Center for Advanced Pediatrics

    Atlanta, Georgia, 30329

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

    Atlanta, Georgia, 30329

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Connecticut Children's Ambulatory Surgical Center

    Farmington, Connecticut, 06032

  • Connecticut Children's Infusion Center

    Farmington, Connecticut, 06032

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

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

    Houston, Texas, 77030

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Northwell Health - Cohen Children's Medical Center

    Lake Success, New York, 11042

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Nicklaus Children's Hospital

    Miami, Florida, 33155

  • Northwell Health - Cohen Children's Medical Center

    New Hyde Park, New York, 11040

  • Buerger Center for Advanced Pediatric Care

    Philadelphia, Pennsylvania, 19104

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Roberts Center for Pediatric Research

    Philadelphia, Pennsylvania, 19146

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

    San Francisco, California, 94158

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

    San Francisco, California, 94158

  • Seattle Children's Hospital

    Seattle, Washington, 98105

Other trials in United States

Japan10 sites

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431

  • Osaka Women's and Children's Hospital

    Izumi, Osaka, 594-1101

  • Kurume University Hospital

    Kurume-shi, Fukuoka, 830-0011

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Aichi Children's Health and Medical Center

    Obu-shi, Aichi-ken, 474-8710

  • Saitama Prefectural Children's Medical Center

    Saitama-shi, Saitama, 330-8777

  • Miyagi Children's Hospital

    Sendai, Miyagi, 989-3126

  • National Center for Child Health and Development

    Setagaya-ku, Tokyo, 157-8535

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329 0498

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka, 569-8686

Other trials in Japan

Canada7 sites

  • Stollery Children's Hospital University of Alberta

    Edmonton, Alberta, T6G 1C9

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • London Health Sciences Centre - Children's Hospital

    London, Ontario, N6A 5W9

  • London Health Sciences Centre - Children's Hospital

    London, Ontario, N6C2R5

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

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

    Toronto, Ontario, M5G 1X8

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3N1

Other trials in Canada

Israel5 sites

  • Shamir Medical Center (Assaf Harofeh)

    Be’er Ya‘aqov, 7033001

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Schneider Children's Medical Center of Israel

    Petah Tikva, 4920235

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Poland5 sites

  • Instytut "Centrum Zdrowia Matki Polki"

    Lodz, 93-338

  • Korczowski Bartosz, Gabinet Lekarski

    Rzeszów, 35-302

  • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś

    Warsaw, Masovian Voivodeship, 04-501

  • Instytut "Pomnik - Centrum Zdrowia Dziecka"

    Warsaw, 04-730

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    Wroclaw, 50-369

Other trials in Poland

Belgium4 sites

  • Hôpital Universitaire Des Enfants Reine Fabiola

    Brussels, 1020

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitaire Ziekenhuizen Leuven

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

Italy4 sites

  • ASST Papa Giovanni XXIII Epatologia e Gastroenterologia Pediatrica e dei Trapianti

    Bergamo, BG, 24127

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

    Bologna, 40133

  • A.O.U. Federico II

    Naples, Naples, 80131

  • Azienda Ospedaliero - Universitaria Policlinico Umberto I di Roma

    Roma, RM, 00161

Other trials in Italy

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 416 50

  • Sachsska Children's and Youth Hospital/South General Hospital

    Stockholm, 118 83

  • Karolinska Universitetssjukhuset Barngastroenterologi, hepatologi och nutrition

    Stockholm, 171 76

Other trials in Sweden

United Kingdom3 sites

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

    Birmingham, WEST Midlands, B4 6NH

  • King's College Hospital NHS Foundation Trust

    London, Greater London, SE5 9RS

  • Bart's Health NHS Trust

    London, E1 1BB

Other trials in United Kingdom

France2 sites

  • CHU de Lyon - Hôpital Femme Mère Enfant

    Bron, 69677

  • Hôpital Necker Enfants Malades

    Paris, 75015

Other trials in France

Netherlands2 sites

  • Amsterdam University Medical Center, VUmc Boelelaan

    Amsterdam, North Holland, 1105 AZ

  • Erasmus Medical Center - Sophia Children's Hospital

    Rotterdam, 3015 GD

Other trials in Netherlands

Australia1 site

  • The Royal Children's Hospital

    Parkville, Victoria, 3052

Other trials in Australia

Finland1 site

  • Tampereen yliopistollinen sairaala

    Tampere, 33520

Other trials in Finland

Germany1 site

  • Dr. von Haunersches Kinderspital, LMU

    Munich, Bavaria, 80337

Other trials in Germany

Hungary1 site

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720

Other trials in Hungary

Slovakia1 site

  • Narodny ustav detskych chorob

    Bratislava, 833 40

Other trials in Slovakia

About this study

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

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.

Read more

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.

Being tested
tofacitinib
Keywords
Ulcerative Colitis, Pediatric, Tofacitinib Oral, Mayo, PUCAI, Flare
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tofacitinibDrug

    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.

Study groups in NCT04624230
Study groupRoleWhat they receive
tofacitinibExperimentalOpen 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.
Receives: Drug: tofacitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Outcome measured at the end of the 44 weeks of the maintenance phase.

Secondary outcomes (17)

  1. 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.

    Measured: Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44

  2. 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).

    Measured: Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44

  3. Change from baseline in Mayo score.

    Measured: Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44

  4. 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.

    Measured: Outcome measured through study completion, an average of 3 and a half years

  5. 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.

    Measured: Outcome measured through study completion, an average of 3 and a half years

  6. 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.

    Measured: Outcome measured through study completion, an average of 3 and a half years

  7. 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.

    Measured: Outcome measured through study completion, an average of 3 and a half years

  8. 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.

    Measured: Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44

  9. Time to flare

    Measured: Outcome measured from 2 to 4 months in the study, through study completion, an average of 3 and a half years

  10. Change from baseline in fecal calprotectin levels

    Measured: Outcome measured through study completion, an average of 3 and a half years

  11. Change from baseline in serum high sensitivity C-Reactive Protein (hsCRP) levels

    Measured: Outcome measured through study completion, an average of 3 and a half years

  12. 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)

    Measured: Outcome measured through study completion, an average of 3 and a half years

  13. Average plasma concentration of tofacitinib (Cavg)

    Measured: Outcome measured at baseline, induction Week 8, induction Week 16, maintenance Week 16, maintenance Week 44

  14. 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.

    Measured: Outcome measured at induction week 2

  15. Peak (maximum) plasma concentration of tofacitinib (Cmax)

    Measured: Outcome measured at baseline, induction Week 8, induction Week 16, maintenance Week 16, maintenance Week 44

  16. 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.

    Measured: Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44

  17. 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.

    Measured: Outcome measured through study completion, an average of 3 and a half years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2020
  2. Study start12 Aug 2021
  3. Primary completion17 Mar 2027 (estimated)
  4. Study completion6 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Single Group
Masking
None (open label)
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04624230
Sponsor's protocol ID
A3921210
Other IDs
2018-002378-30, OVATION, 2023-509694-22-00, 2023, 2018
Status last verified
Jul 2026
First submitted
26 Oct 2020
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • 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. Trends in Epidemiology of Pediatric Inflammatory Bowel Disease in Canada: Distributed Network Analysis of Multiple Population-Based Provincial Health Administrative Databases. Am J Gastroenterol. 2017 Jul;112(7):1120-1134. doi: 10.1038/ajg.2017.97. Epub 2017 Apr 18.

    PubMed 28417994

  • 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 Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.

    PubMed 31504429

  • 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 Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):389-403. doi: 10.1097/MPG.0000000000002567.

    PubMed 32079889

  • 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. Gastroenterology. 2007 Aug;133(2):423-32. doi: 10.1053/j.gastro.2007.05.029. Epub 2007 May 21.

    PubMed 17681163

  • 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: 10.1097/00005176-200210000-00018.

    PubMed 12394384

  • 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 Gastroenterol Nutr. 2017 Mar;64(3):373-377. doi: 10.1097/MPG.0000000000001259.

    PubMed 27159210

  • 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.

    PubMed 11237120

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tofacitinib in people with Ulcerative Colitis, run by Pfizer at 69 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Japan, Canada, Israel, Poland and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Remission by central read Mayo score following 44 weeks in the maintenance phase. (time frame: Outcome measured at the end of the 44 weeks of the maintenance phase.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04624230, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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