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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 is a Phase 3 study of Arthritis, Juvenile that has completed, run by Janssen Research & Development. The registered enrollment target is 130 participants. The trial reports 20 study locations across 12 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02277444
The ClinicalTrials.gov registry entry for NCT02277444 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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