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NCT02277444 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
A Phase 3 study of Arthritis, Juvenile, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT02277444: Completed Phase 3 study of Arthritis, Juvenile, sponsored by Janssen Research & Development.
NCT02277444 is a Phase 3 study of Arthritis, Juvenile that has completed, run by Janssen Research & Development. The registered enrollment target is 130 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02277444, a Phase 3 study of Arthritis, Juvenile, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopathic (of unknown cause) arthritis (joint pain) (pJIA) manifested by greater than or equal to (\>=) 5 joints with active arthritis despite methotrexate (MTX) therapy for \>= 2 months.
Primary Outcome
Serum golimumab trough concentration at Week 28 was reported.
Conditions Studied
Interventions
- DRUG Methotrexate
- DRUG Golimumab
Study Locations (20)
Other
- - Buenos Aires
- - Rosario
- - San Miguel de Tucumán
- - Botucatu
- - Campinas
- - Porto Alegre
Ohio
- - Avon
- - Cincinnati
- - Cleveland
North Carolina
- - Durham
- - Hickory
California
- - San Diego
Illinois
- - Chicago
Massachusetts
- - Boston
New Jersey
- - Hackensack
New York
- - New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2014-12-22 |
| Est. Completion | 2024-09-27 |
| Phase | Phase 3 |
What the finished NCT02277444 record still lists
NCT02277444 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Arthritis, Juvenile appearing as the primary indexed condition, and to 2 interventions - of which Methotrexate is the first listed.
NCT02277444 names 20 study sites across 12 states, led by Other, Ohio, North Carolina.
Frequently Asked Questions
What is clinical trial NCT02277444 about?
NCT02277444 is a clinical study titled "A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy". The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with polyarticular (affects 5 or more joints) juvenile (an onset before age 16) idiopat...
What is the current status of trial NCT02277444?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 130 participants. The study started on 2014-12-22. Estimated completion is 2024-09-27.
What conditions does trial NCT02277444 study?
This clinical trial studies the following conditions: Arthritis, Juvenile.
What interventions are being tested in trial NCT02277444?
The interventions under investigation include: Methotrexate (DRUG), Golimumab (DRUG).
Who is sponsoring clinical trial NCT02277444?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02277444 being conducted?
This trial has 20 study locations across California, Illinois, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Arthritis, Juvenile
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02277444's enrollment target sits among peer trials
130 1594th of 2000 higher than 404 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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