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Upadacitinib for Juvenile Arthritis (SELECT-YOUTH Trial)
SELECT-YOUTH Trial Summary
This trial will assess the effects of a new drug on children with juvenile idiopathic arthritis. The study will be conducted in three parts, with the option for participants to enroll in the second and third parts if they do not experience any adverse effects from the study drug.
SELECT-YOUTH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSELECT-YOUTH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 3 trial • 613 Patients • NCT03086343SELECT-YOUTH Trial Design
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- I weigh at least 10 kg.I have been treated with a JAK inhibitor before.I have been on a stable dose of methotrexate for at least 8 weeks and take folic or folinic acid.I have been on a stable dose of oral glucocorticosteroids for at least a week.I have been diagnosed with a type of juvenile arthritis affecting 5 or more joints within the first 6 months.I have 5 or more joints with swelling, pain, or limited movement.I have been diagnosed with ERA or JPSA.
- Group 1: Participants of age group 12 to <18 years receiving dose A
- Group 2: Participants of age group 12 to <18 years receiving dose B
- Group 3: Participants of age group 6 to <12 years receiving dose A
- Group 4: Participants of age group 2 to <6 years receiving dose A
- Group 5: Participants of age group 2 to <18 years receiving dose A
- 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
Are there any specific demographics that would be more suited to participate in this trial?
"This clinical trial is seeking 124 patients aged between 2 and 17 suffering from juvenile arthritis. In order to be accepted, candidates must have been taking methotrexate for a minimum of 12 weeks prior to the start date at a stable dose of 10-20 mg/m2; they should also take either folic acid or folinic acid according to local protocol. Furthermore, participants need to possess total body weight greater than 10 kg upon screening and fulfill criteria such as being diagnosed with pcJIA (rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA"
What clinical applications has Upadacitinib seen success in?
"Upadacitinib is mostly used as a systemic therapy for individuals afflicted with rheumatoid arthritis, methotrexate, and any other condition that has not responded to conventional treatments."
To what degree has Upadacitinib been tested in clinical trials previously?
"Upadacitinib was initially studied in 2015 by AZ Arthritis and Rheum Assoc (ID# 143130). Thus far, there have been 21 successful trials with an additional 21 presently underway around the Cincinnati region."
What is the maximum number of individuals who will be enrolled in this trial?
"This trial requires 124 participants who meet its eligibility criteria. These patients can be recruited from 2 different medical centres; Cincinnati Childrens Hosp Med/ID# 209697 situated in Cincinnati, Ohio and a second branch at the Cincinnati Childrens Hospital Medical Center / ID#209697 based in Philadelphia, Pennsylvania."
Does the protocol for this trial include participants aged thirty and above?
"The inclusion criteria for this experiment necessitates that participants are between the ages of two and seventeen. Subsequently, there are 62 total studies aimed at minors and 333 specifically targeting those over 65 years of age."
Are any North American healthcare facilities conducting this trial?
"This clinical trial is occurring at 11 different sites, the most prominent of which are the Cincinnati Childrens Hosp Med in Ohio, the Cincinnati Children's Hospital Medical Center in Pennsylvania and the Children's Hospital of Philadelphia in Washington."
Is the opportunity for participation in this trial available to individuals currently?
"According to clinicaltrials.gov, this medical trial has been ongoing since June 24th 2019 and is still currently recruiting patients. The most recent update was on October 17th 2022."
Is this research unprecedented in its scope?
"Since 2015, research into Upadacitinib has been conducted. Originally sponsored by AbbVie in 2015 with 1629 patients, the drug was granted Phase 3 approval following this study. Nowadays there are 21 clinical trials for Upadacitinib across 54 countries and 953 cities."
Has Upadacitinib been sanctioned by the FDA?
"Data collected thus far on Upadacitinib's safety and efficacy suggest that it should receive a score of 1."
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