A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
Public ClinicalTrials.gov record NCT00642460. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of Tocilizumab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00642460
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 112 participants
Conditions and interventions
Conditions
Interventions
- tocilizumab [RoActemra/Actemra] Drug
- Placebo Drug
- Non-steroidal anti-inflammatory drugs (NSAIDs) Drug
- methotrexate Drug
- corticosteroids Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2008 (Type not available)
- Primary completion
- Sep 2009 (Actual)
- Completion
- Aug 2014 (Actual)
- Last update posted
- Jul 25, 2016
2008 – 2014
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Little Rock | Arkansas | 45229-3039 | — |
| Not listed | Los Angeles | California | 90027 | — |
| Not listed | Hartford | Connecticut | 06106 | — |
| Not listed | Augusta | Georgia | 30912 | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Louisville | Kentucky | 40202-3906 | — |
| Not listed | Hackensack | New Jersey | 07601 | — |
| Not listed | Livingston | New Jersey | 07039 | — |
| Not listed | Durham | North Carolina | 27710 | — |
| Not listed | Cincinnati | Ohio | 45229 | — |
| Not listed | Cleveland | Ohio | 44195 | — |
| Not listed | Oklahoma City | Oklahoma | 73104 | — |
| Not listed | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00642460, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 25, 2016 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00642460 live on ClinicalTrials.gov.