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Tofacitinib for Immune Skin Conditions in Down Syndrome
Study Summary
This trial tests if a drug that blocks interferon signaling is safe and effective in people with Down syndrome and an autoimmune or autoinflammatory skin condition.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 3 trial • 209 Patients • NCT02281552Trial Design
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Who is running the clinical trial?
Media Library
- I had a kidney transplant within the last two years.I have a history of lymphoma.I have moderate-to-severe skin condition with painful lumps.I have moderate to severe vitiligo.I have moderate-to-severe eczema.I have had a skin infection in the last 2 weeks.I am unable to give my own consent for the trial.I have not received a live vaccine in the last six weeks and do not plan to during the study.I weigh less than 40 kg.I haven't taken JAK inhibitors or been part of any clinical trials in the last 3 weeks.You have a history of widespread herpes infections or repeat outbreaks of shingles in a specific area of your skin.I have lost at least 25% of my hair.I am between 12 and 50 years old, have Down syndrome, and weigh at least 40 kg.I am not taking other immunosuppressants or specific enzyme affecting drugs.I haven't taken any oral antibiotics in the last 2 weeks.I have moderate to severe psoriasis.I have had a heart attack or stroke in the past.I have not had IV antibiotics in the last 3 months.I do not have any significant ongoing or chronic viral infections like HIV or hepatitis.You have smoked in the past or currently smoke.You have an allergy or bad reaction to tofacitinib.I have a history of blood clots.I have severe kidney problems.I am between 12 and 50 years old, have Down syndrome, and weigh at least 40 kg.I have a severe skin condition like eczema, psoriasis, or vitiligo.I have had cancer in the past 5 years or it has come back.
- Group 1: On Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Have prior studies been conducted on the efficacy of Tofacitinib?
"Tofacitinib is being explored in 34 different clinical studies, with 7 of those trials currently at Phase 3. Although the majority are based out of Shanghai, there are 662 sites conducting research on this medication worldwide."
What is the desired outcome of this research endeavor?
"The fundamental objective of this 18 week study is to gauge any alterations in interferon scores within white blood cells. Secondary endpoints include changes in Psoriasis Area and Severity Index (PASI) Score, Eczema Area and Severity Index (EASI), as well as Modified Sartorius Score (MSS). PASI scoring quantifies the area and severity of psoriasis based on parameters like erythema, induration, desquamation; while EASI utilizes 4 measurements such as erythema, infiltration, excoriations and lichenification for assessing eczema's"
How many enrollees are being accepted for this medical experiment?
"Correct. Data on clinicaltrials.gov verifies that this research endeavour, which was initially listed on October 21st 2020, is actively recruiting patients. Approximately 47 individuals need to be enrolled from 1 centre."
Is this clinical research actively seeking participants?
"Indeed, records from clinicaltrials.gov disclose that the trial is currently recruiting participants. It was published on October 21st 2020 and underwent its most recent update on July 27th 2022; 47 people are needed for this study across 1 clinic location."
Is Tofacitinib a risk-free treatment option for patients?
"Tofacitinib has been evaluated in Phase 2 trials and is thought to be reasonably safe, so it earned a rating of 2. No clinical data currently exists demonstrating efficacy however."
Is this research study accessible to individuals aged forty and above?
"According to the enrollment guidelines, prospective patients should be between 12 and 50 years of age. There are 530 trials for those under 18 while 1448 studies have been developed with seniors in mind."
Am I eligible to join the experiment?
"Patients with hidradenitis suppurativa are being recruited for this trial if they fall in the 12 to 50 year age range. Currently, 47 participants have been accepted into the study."
What primary applications is Tofacitinib employed for?
"Tofacitinib is primarily prescribed for children suffering from juvenile arthritis. Additionally, it can be a useful treatment option in cases where patients are intolerant to methotrexate and have not responded well enough to traditional therapies."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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How many prior treatments have patients received?
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