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Janus Kinase (JAK) Inhibitor

Oral Tofacitinib for Ulcerative Colitis in Children

Phase 3

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No history of dysplasia or colon cancer

No evidence or history of untreated or inadequately treated active or latent infection with Mycobacterium Tuberculosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up outcome measured through study completion, an average of 3 and a half years

Awards & highlights

Study Summary

This trial is designed to see if tofacitinib is effective in treating pediatric UC patients who have either failed or been intolerant to other treatments. The primary objective is to see if the patients go into remission after 44 weeks of treatment.

Who is the study for?

Children aged 2-17 with moderate to severe ulcerative colitis (UC) can join this trial. They must weigh at least 10 kg and have a confirmed UC diagnosis for over 12 weeks, with specific test results showing active disease. Those who've had certain treatments or surgeries recently, live vaccines, or have other health issues like infections or low blood counts cannot participate.Check my eligibility

What is being tested?

The trial is testing the drug Tofacitinib in children with UC. It starts with an open-label phase where all participants get Tofacitinib; doses may increase if needed. The main goal is to see if the drug helps achieve remission after 44 weeks of treatment by checking Mayo scores.See study design

What are the potential side effects?

Possible side effects of Tofacitinib include increased risk of infections, changes in blood cell counts, liver enzyme alterations, and potential interactions with other medications that affect immune response or liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had colon cancer or precancerous colon conditions.

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I do not have an untreated or poorly treated TB infection.

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My ulcerative colitis is moderate to severe, confirmed by a colonoscopy.

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I am between 2 and 17 years old and weigh at least 10 kg.

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I was diagnosed with UC before 6 and tested negative for related genetic disorders.

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My child's UC severity score is 35 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ outcome measured through study completion, an average of 3 and a half years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~outcome measured through study completion, an average of 3 and a half years

This trial's timeline: 3 weeks for screening, Varies for treatment, and outcome measured through study completion, an average of 3 and a half years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Remission by central read Mayo score following 44 weeks in the maintenance phase.

Secondary outcome measures

Average plasma concentration of tofacitinib (Cavg)

Change from baseline in Mayo score.

Change from baseline in PUCAI score

+14 more

Side effects data

From 2020 Phase 4 trial • 4372 Patients • NCT02092467

22%

Upper respiratory tract infection

15%

Bronchitis

13%

Rheumatoid arthritis

13%

Urinary tract infection

12%

Nasopharyngitis

12%

Fall

12%

Herpes zoster

Hypertension

Arthralgia

Diarrhoea

Lymphopenia

Sinusitis

Back pain

Influenza

Osteoarthritis

Latent tuberculosis

Pharyngitis

Nausea

Anaemia

Alanine aminotransferase increased

Cough

Gastroenteritis

Pneumonia

Headache

Coronary artery disease

Femur fracture

Cellulitis

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Tofacitinib 5 mg BID

Tofacitinib 10 mg BID

TNFi

Trial Design

1Treatment groups

Experimental Treatment

Group I: tofacitinibExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

tofacitinib

2012

Completed Phase 4

~5620

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor

4,570 Previous Clinical Trials

10,915,906 Total Patients Enrolled

32 Trials studying Ulcerative Colitis

425,914 Patients Enrolled for Ulcerative Colitis

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,476 Previous Clinical Trials

8,092,101 Total Patients Enrolled

26 Trials studying Ulcerative Colitis

11,835 Patients Enrolled for Ulcerative Colitis

Media Library

Tofacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04624230 — Phase 3

Ulcerative Colitis Research Study Groups: tofacitinib

Ulcerative Colitis Clinical Trial 2023: Tofacitinib Highlights & Side Effects. Trial Name: NCT04624230 — Phase 3

Tofacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04624230 — Phase 3

Ulcerative Colitis Patient Testimony for trial: Trial Name: NCT04624230 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients who are over 30 years old still being accepted for this study?

"To be eligible for this particular clinical trial, patients must be aged 2 to 17. In total, there are 75 clinical trials for patients under the age of 18 and 392 clinical trials for patients over the age of 65."

Answered by AI

Are there any positions still open for this research project?

"That is accurate. The information available on clinicaltrials.gov shows that this clinical trial is open and looking for participants. The trial was originally posted on August 12th, 2021 and was last updated on October 4th, 2022. They are seeking 120 patients total from 40 different locations."

Answered by AI

How many individuals are being given this therapy as part of the research?

"The pharmaceutical company sponsoring this study, Pfizer, needs to recruit 120 eligible patients from different hospitals including The Hospital for Sick Children - Division of Gastroenterology, Hepatology and Nutrition in Toronto, Ontario and University of Alberta Hospital in Farmington, Connecticut."

Answered by AI

Eligibility requirements for this research project?

"This study is looking for 120 participants that have colitis or ulcerative between the ages of 2 and 17. To be eligible, patients must meet the following criteria: have a signed and dated informed consent document and assent document, be male or female and 2 to less than 18 years old and weigh at least 10 kg, have a pathology report that confirms colonic inflammation consistent with UC and a clinical diagnosis of UC for at least 12 weeks prior to baseline, with biopsy report supporting the diagnosis of UC, be Moderately to severely active UC as defined (via screening colonoscopy) by a Mayo score of at least"

Answered by AI

What is the main disease that tofacitinib has been shown to improve?

"Tofacitinib is used to treat juvenile arthritis and other conditions such as methotrexate intolerance, methotrexate, and inadequate response to conventional therapy."

Answered by AI

Did the FDA clear tofacitinib for use?

"Because tofacitinib has undergone multiple rounds of testing and has some efficacy data, Power has given it a safety rating of 3."

Answered by AI

What other investigations have included tofacitinib in their research?

"Tofacitinib was first studied in 2007 at University of Nebraska Medical Center. Since then, 118 clinical trials have been completed with 34 more currently underway. A majority of these live trials are being conducted in Toronto, Canada."

Answered by AI