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NCT00886769 · ClinicalTrials.gov registry record · Phase 3

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Terminated
Registry status
Phase 3
Development phase
84
Enrollment target

NCT00886769: Clinical Trial Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT00886769 is a Phase 3 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 84 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00886769, a Phase 3 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.

TERMINATED
Registry status
Phase 3
Development phase
84 participants
Enrollment target

Study Summary

This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

Primary Outcome

Adapted ACR Pediatric 30 criteria determined responders (improved from baseline of at least 30% in at least 3 response variables 1-6 and no intermittent fever in preceding week \[variable 7\], with no more than one variable 1-6 worsening \> 30% ) 1. Physician's Global Assessment of disease activity: 0-100 mm VAS 2.Parent/Patient's Global Assessment of Patient's overall wellbeing: 0-100mmVAS in Child Health Assessment Questionnaire (CHAQ) 3. Functional ability: CHAQ 4.Number of joints with active

Interventions

  • DRUG Placebo
  • DRUG Canakinumab

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2009-07
Est. Completion 2011-01
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

Why NCT00886769 stopped before completion

NCT00886769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00886769 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00886769 about?

NCT00886769 is a clinical study titled "Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)". This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

What is the current status of trial NCT00886769?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2009-07. Estimated completion is 2011-01.

What interventions are being tested in trial NCT00886769?

The interventions under investigation include: Placebo (DRUG), Canakinumab (DRUG).

Who is sponsoring clinical trial NCT00886769?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00886769's enrollment target sits among peer trials

84 1749th of 2000 higher than 250 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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Source: ClinicalTrials.gov NCT00886769, the US trial registry maintained by the National Library of Medicine. NCT00886769 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.