Trials / Completed
CompletedNCT02396212
Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA
An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 2 Years – 19 Years
- Healthy volunteers
- Not accepted
Summary
This was a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s.c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study supported a registration submission of canakinumab in the indication of SJIA in Japan.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Canakinumab | canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks. |
Timeline
- Start date
- 2015-05-07
- Primary completion
- 2017-03-07
- Completion
- 2018-08-01
- First posted
- 2015-03-24
- Last updated
- 2019-09-13
- Results posted
- 2019-09-13
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02396212. Inclusion in this directory is not an endorsement.