| September 2, 2005 |
| June 15, 2009 |
| July 2004 |
| June 2005 (final data collection date for primary outcome measure) |
- Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study) [ Time Frame: whole period ] [ Designated as safety issue: No ]
- Safety:Incidence and severity of adverse events and adverse reactions [ Time Frame: whole period ] [ Designated as safety issue: Yes ]
- Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ] [ Designated as safety issue: No ]
|
- Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study)
- Incidence and severity of adverse events and adverse reactions
- The time profile of the trough serum MRA concentration
- Efficacy:
- Safety:
- Pharmacokinetics:
- at 0W, then every 2Wks
|
| Complete list of historical versions of study NCT00144612 on ClinicalTrials.gov Archive Site |
| Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks [ Time Frame: 0 week and every 2 weeks ] [ Designated as safety issue: No ] |
- Efficacy:
- Time profiles of CRP and ESR, Time profile of percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, Time profiles of JIA core set variables, Time profile of pain, Time profile of corticosteroid dose
- at 0W, then every 2Wks
|
| |
| Long-Term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA) |
| An Open-Label, Extension, Phase III Study to Evaluate the Long-Term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP |
An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP |
| |
| Phase III |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Systemic Juvenile Idiopathic Arthritis |
| Drug: MRA(Tocilizumab) |
| |
| Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008 Mar 22;371(9617):998-1006. |
| |
| Active, not recruiting |
| 60 |
| July 2009 |
| June 2005 (final data collection date for primary outcome measure) |
Inclusion criteria (MRA011JP patients)
- Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
- the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
- Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
- Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period
Exclusion criteria
- Patients who were not enrolled by 3 months after completion of the previous study
- Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study
|
| Both |
| 2 Years to 19 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00144612 |
| Chugai Pharmaceutical, Chugai Pharmaceutical |
| MRA317JP |
| Chugai Pharmaceutical |
|
| Study Director: |
Takahiro Kakehi |
Chugai Pharmaceutical |
|
|
| Chugai Pharmaceutical |
| June 2009 |
