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NCT00988221 · ClinicalTrials.gov registry record · Phase 3
A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
NCT00988221 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 188 participants.
The verdict
NCT00988221, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
Study Summary
This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients \< 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.
Interventions
- DRUG Placebo
- DRUG Tocilizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2009-11-30 |
| Est. Completion | 2013-01-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00988221
The ClinicalTrials.gov registry entry for NCT00988221 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 188 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 2 interventions - of which Placebo is the first listed.
NCT00988221 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00988221 about?
NCT00988221 is a clinical study titled "A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis". This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizuma...
What is the current status of trial NCT00988221?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2009-11-30. Estimated completion is 2013-01-28.
What interventions are being tested in trial NCT00988221?
The interventions under investigation include: Placebo (DRUG), Tocilizumab (DRUG).
Who is sponsoring clinical trial NCT00988221?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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