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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
Must not have
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.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up outcome measured through study completion, an average of 3 and a half years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
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.
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.
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 belowSelect...
I have never had colon cancer or precancerous colon conditions.
Select...
I do not have an untreated or poorly treated TB infection.
Select...
My ulcerative colitis is moderate to severe, confirmed by a colonoscopy.
Select...
I am between 2 and 17 years old and weigh at least 10 kg.
Select...
I was diagnosed with UC before 6 and tested negative for related genetic disorders.
Select...
My child's UC severity score is 35 or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had major bowel surgery or recent hospital visits for UC.
Select...
I am not taking, nor plan to take, certain strong medications that affect drug metabolism during the study.
Select...
I have not had major surgery or significant trauma in the last 4 weeks.
Select...
I have not taken specific immune system affecting drugs recently.
Select...
I have not had a live vaccine recently nor plan to during the study.
Select...
I regularly use medication to control chronic diarrhea.
Select...
I have taken tofacitinib or a similar medication before.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Remission by central read Mayo score following 44 weeks in the maintenance phase.
Secondary study objectives
Change from baseline in PUCAI score
Change from baseline in Partial Mayo score
Corticosteroid free remission by Partial Mayo Score
+8 moreSide effects data
From 2020 Phase 4 trial • 4372 Patients • NCT0209246722%
Upper respiratory tract infection
15%
Bronchitis
13%
Rheumatoid arthritis
13%
Urinary tract infection
12%
Nasopharyngitis
12%
Fall
12%
Herpes zoster
9%
Hypertension
8%
Arthralgia
7%
Diarrhoea
7%
Lymphopenia
7%
Sinusitis
7%
Back pain
6%
Osteoarthritis
6%
Influenza
6%
Latent tuberculosis
6%
Pharyngitis
5%
Nausea
5%
Anaemia
5%
Alanine aminotransferase increased
5%
Cough
4%
Gastroenteritis
3%
Pneumonia
3%
Headache
1%
Coronary artery disease
1%
Femur fracture
1%
Cellulitis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib 5 mg BID
Tofacitinib 10 mg BID
TNFi
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,651 Previous Clinical Trials
17,742,593 Total Patients Enrolled
40 Trials studying Colitis
10,309 Patients Enrolled for Colitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,538 Previous Clinical Trials
14,913,770 Total Patients Enrolled
32 Trials studying Colitis
9,760 Patients Enrolled for Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had major bowel surgery or recent hospital visits for UC.I have never had colon cancer or precancerous colon conditions.I do not have an untreated or poorly treated TB infection.I am not taking, nor plan to take, certain strong medications that affect drug metabolism during the study.I have not had major surgery or significant trauma in the last 4 weeks.My ulcerative colitis is moderate to severe, confirmed by a colonoscopy.I am between 2 and 17 years old and weigh at least 10 kg.I haven't had blood filtering treatments like leukocyte apheresis in the last 6 months.I have been diagnosed with ulcerative colitis for at least 12 weeks, confirmed by a biopsy.I was diagnosed with UC before 6 and tested negative for related genetic disorders.I have not taken specific immune system affecting drugs recently.I have not had a live vaccine recently nor plan to during the study.My child's UC severity score is 35 or higher.I regularly use medication to control chronic diarrhea.I have taken tofacitinib or a similar medication before.I have been diagnosed with a specific type of colitis or Crohn's disease.
Research Study Groups:
This trial has the following groups:- Group 1: tofacitinib
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Colitis Patient Testimony for trial: Trial Name: NCT04624230 — Phase 3
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