Phase 3: testing Adalimumab for Juvenile Psoriatic Arthritis
Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time.
Official registry: https://clinicaltrials.gov/study/NCT06100744 · AbbVie · enrollment listed as 40
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Adalimumab, or Risankizumab. The registry lists allocation as randomized. Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling.
They plan to enroll about 40 people at 34 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis
Interventions: Adalimumab, Risankizumab
Primary outcome (registry wording): Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)
Who it is for (from inclusion criteria)
- Ages 5 Years to 17 Years
- Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 months prior to screening
- Active Disease in \>= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study
Who the registry excludes
- Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes
Public study contact (from the registry)
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
34 listed- Arkansas Children's Hospital /ID# 258776 — Little Rock, Arkansas (recruiting)
- Childrens National Medical Center /ID# 259284 — Washington D.C., District of Columbia (recruiting)
- Joe Dimaggio Children's Hospital Hollywood /ID# 260634 — Hollywood, Florida (recruiting)
- All X Ray Diagnostic Services Corp /ID# 278523 — Miami, Florida (recruiting)
- Indiana University Health Riley Hospital for Children /ID# 259067 — Indianapolis, Indiana (recruiting)
- M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111 — Minneapolis, Minnesota (recruiting)
- Columbia University Medical Center /ID# 262587 — New York, New York (recruiting)
- Boston Childrens Health Physicians /ID# 258061 — Valhalla, New York (recruiting)
- University of North Carolina - Children's Hospital /ID# 259286 — Chapel Hill, North Carolina (recruiting)
- MetroHealth Medical Center /ID# 262377 — Cleveland, Ohio (recruiting)
- Cleveland Clinic - Cleveland /ID# 276655 — Cleveland, Ohio (recruiting)
- Child Neurology Consultants of Austin /ID# 260562 — Austin, Texas (recruiting)
+ 22 sites outside the US on the same record
FAQ about this NCT record
Is NCT06100744 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06100744?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06100744?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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