Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00642460 · ClinicalTrials.gov registry record · Phase 3
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
NCT00642460 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 112 participants.
The verdict
NCT00642460, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients \>=30kg, or 12mg/kg for patients \<30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will be continued throughout. After 12 weeks of double-blind treatment, all patients will have the option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which, for patients who meet specific criteria, an optional alternative dosing schedule decreasing the study drug administration frequency will be introduced. Anticipated time on study treatment is up to 5 years.
Interventions
- DRUG Placebo
- DRUG methotrexate
- DRUG tocilizumab [RoActemra/Actemra]
- DRUG corticosteroids
- DRUG Non-steroidal anti-inflammatory drugs (NSAIDs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2008-05 |
| Est. Completion | 2014-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00642460
The ClinicalTrials.gov registry entry for NCT00642460 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00642460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00642460 about?
NCT00642460 is a clinical study titled "A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)". This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be randomized 2:1 to receive iv infus...
What is the current status of trial NCT00642460?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2008-05. Estimated completion is 2014-08.
What interventions are being tested in trial NCT00642460?
The interventions under investigation include: Placebo (DRUG), methotrexate (DRUG), tocilizumab [RoActemra/Actemra] (DRUG), corticosteroids (DRUG), Non-steroidal anti-inflammatory drugs (NSAIDs) (DRUG).
Who is sponsoring clinical trial NCT00642460?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.