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Janus Kinase (JAK) Inhibitor
Upadacitinib for Juvenile Arthritis (SELECT-YOUTH Trial)
Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant have total body weight of 10 kg or higher at the time of screening.
If receiving methotrexate (MTX), have been taking MTX for at least 12 weeks immediately before and including Study Day 1 on a stable dose of 10 to 20 mg/m2 for at least 8 weeks before and including Study Day 1; in addition, participants should take either folic acid or folinic acid according to local standard of care.
Must not have
Participant have prior exposure to JAK inhibitor.
Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 156 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a medication called upadacitinib in children with a type of arthritis that affects many joints. The study aims to see how the drug behaves in their bodies, how safe it is, and how well they can tolerate it. Upadacitinib works by reducing inflammation and pain by blocking certain enzymes in the body. It has been approved for treating rheumatoid arthritis in adults.
Who is the study for?
This trial is for children with polyarticular course juvenile idiopathic arthritis (pcJIA) who have at least 5 active joints and weigh over 10 kg. They must have been diagnosed with pcJIA, possibly taking methotrexate for 12 weeks or more, and if on steroids, they should be on a stable dose. Kids with enthesitis-related arthritis or juvenile psoriatic arthritis, or those previously treated with JAK inhibitors can't participate.
What is being tested?
The study tests Upadacitinib's effects in kids with pcJIA across three parts: initial multiple-dose groups, an open-label extension to assess long-term safety/tolerability, and an additional cohort for further safety evaluation. The goal is to understand how the drug works in young bodies and monitor its ongoing safety.
What are the potential side effects?
While specific side effects are not listed here, typically such trials look out for any adverse reactions related to the medication being tested which could include gastrointestinal issues, skin reactions, changes in blood counts or liver enzymes among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 10 kg.
Select...
I have been on a stable dose of methotrexate for at least 8 weeks and take folic or folinic acid.
Select...
I have 5 or more joints with swelling, pain, or limited movement.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a JAK inhibitor before.
Select...
I have been diagnosed with ERA or JPSA.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 156 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 156 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part 1: Apparent oral clearance at steady state (CL/F)
Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)
Part 1: Half-life
+3 moreSide effects data
From 2023 Phase 3 trial • 657 Patients • NCT0308634324%
UPPER RESPIRATORY TRACT INFECTION
24%
HYPERTENSION
18%
BRONCHITIS
12%
ACUTE RESPIRATORY FAILURE
12%
URINARY TRACT INFECTION
12%
INFLUENZA
12%
FALL
12%
ARTHRALGIA
12%
WEIGHT INCREASED
12%
SINUSITIS
12%
MUSCLE SPASMS
12%
CHOLELITHIASIS
12%
NASOPHARYNGITIS
12%
LIVER FUNCTION TEST INCREASED
12%
RASH
12%
OROPHARYNGEAL PAIN
6%
ASTHMA
6%
HEPATIC STEATOSIS
6%
DEHYDRATION
6%
NASAL CONGESTION
6%
PULMONARY EMBOLISM
6%
HYPONATRAEMIA
6%
CONSTIPATION
6%
RHINORRHOEA
6%
LEUKOCYTOSIS
6%
BLOOD PRESSURE INCREASED
6%
COUGH
6%
BONE CONTUSION
6%
HIP FRACTURE
6%
VOMITING
6%
PERIPHERAL SWELLING
6%
STAPHYLOCOCCAL INFECTION
6%
ORAL CANDIDIASIS
6%
PNEUMONIA
6%
FEELING HOT
6%
HEADACHE
6%
HAEMOGLOBIN DECREASED
6%
COSTOCHONDRITIS
6%
RHEUMATOID ARTHRITIS
6%
PARAESTHESIA
6%
PHOTODERMATOSIS
6%
PNEUMONIA BACTERIAL
6%
HYPOKALAEMIA
6%
STOMATITIS
6%
PATELLA FRACTURE
6%
ACTINIC KERATOSIS
6%
GLAUCOMA
6%
BACTERIAL SEPSIS
6%
CHEST PAIN
6%
FATIGUE
6%
ATRIOVENTRICULAR BLOCK FIRST DEGREE
6%
CANDIDA INFECTION
6%
TACHYCARDIA
6%
COVID-19
6%
CATARACT
6%
INFECTIOUS PLEURAL EFFUSION
6%
SJOGREN'S SYNDROME
6%
DIZZINESS
6%
DYSPHAGIA
6%
SWELLING
6%
ACUTE KIDNEY INJURY
6%
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
6%
HERPES ZOSTER
6%
OSTEOARTHRITIS
6%
NAUSEA
6%
NON-CARDIAC CHEST PAIN
6%
RHINITIS
6%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
OSTEOPENIA
6%
FEMUR FRACTURE
6%
LIGAMENT RUPTURE
6%
SKIN LACERATION
6%
SUPRAVENTRICULAR TACHYCARDIA
6%
SCRATCH
6%
SEBORRHOEIC KERATOSIS
6%
EYE HAEMATOMA
6%
INSOMNIA
6%
ERYTHEMA
6%
PRURITUS
6%
DERMATITIS ALLERGIC
6%
FLANK PAIN
6%
SCIATICA
6%
ANAEMIA
6%
BILIARY COLIC
6%
DERMATITIS CONTACT
6%
DRUG HYPERSENSITIVITY
6%
HERPES SIMPLEX
6%
LOCALISED INFECTION
6%
PHARYNGITIS
6%
DIABETES MELLITUS
6%
VITAMIN D DEFICIENCY
6%
BACK PAIN
6%
VULVOVAGINAL MYCOTIC INFECTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD
Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD
Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, 30 mg Cohort: Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD
Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD
Period 1, Primary and 30 mg Cohorts: Abatacept
Period 1, Primary Cohort: Upadacitinib 15 mg QD
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Participants of age group 6 to <12 years receiving dose AExperimental Treatment1 Intervention
Participants of age group 6 to \<12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Group II: Participants of age group 2 to <6 years receiving dose AExperimental Treatment1 Intervention
Participants of age group 2 to \<6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Group III: Participants of age group 2 to <18 years receiving dose AExperimental Treatment1 Intervention
Participants of age group 2 to \<18 years administered with upadacitinib dose A as described in the protocol.
Group IV: Participants of age group 12 to <18 years receiving dose BExperimental Treatment1 Intervention
Participants of age group 12 to \<18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.
Group V: Participants of age group 12 to <18 years receiving dose AExperimental Treatment1 Intervention
Participants of age group 12 to \<18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Upadacitinib
2014
Completed Phase 3
~11250
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Janus Kinase (JAK) inhibitors, such as Upadacitinib, work by blocking the activity of enzymes in the JAK family, which are crucial in the signaling pathways that lead to inflammation. By inhibiting these enzymes, JAK inhibitors reduce the production of inflammatory cytokines, thereby decreasing inflammation and immune response.
This mechanism is vital for Juvenile Idiopathic Arthritis (JIA) patients as it helps control symptoms like joint pain, swelling, and stiffness, and can prevent long-term joint damage. Other common treatments for JIA include methotrexate, which reduces cell proliferation, and biologics like TNF inhibitors, which block inflammatory pathways.
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
1,031 Previous Clinical Trials
521,618 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
452 Previous Clinical Trials
162,104 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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