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NCT01230827 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
NCT01230827: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT01230827 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 173 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01230827, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
Primary Outcome
Percentage of participants with American College of Rheumatology (ACR) Ped 30 responders at Week 16 who did not experience a flare of disease between Week 16 and Week 48 calculated as number of participants with response and who did not experience flare divided by number of participants randomized. Flare of disease was defined as the worsening from Week 16 by 30% or more in 3 of the 6 ACR Pediatric (Ped) Core Set Variables with no more than 1 of the 6 ACR Ped Core Set variables improving by more
Interventions
- DRUG Placebo
- DRUG Methotrexate
- DRUG CNTO 148 (Golimumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2010-12 |
| Est. Completion | 2014-05 |
| Phase | Phase 3 |
Why NCT01230827 stopped before completion
NCT01230827 is an interventional study that assigns participants to a tested intervention. The registered 173 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 (78% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01230827 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01230827 about?
NCT01230827 is a clinical study titled "A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)". The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
What is the current status of trial NCT01230827?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2010-12. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01230827?
The interventions under investigation include: Placebo (DRUG), Methotrexate (DRUG), CNTO 148 (Golimumab) (DRUG).
Who is sponsoring clinical trial NCT01230827?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01230827's enrollment target sits among peer trials
173 1445th of 2000 higher than 553 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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