Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This Phase IV, multicenter, single-arm, open-label study will evaluate the efficacy and safety of tocilizumab in Chinese participants with sJIA with persistent activity and an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and steroid therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tocilizumab | Experimental | Participants weighing greater than or equal to (>/=) 30 kilograms (kg) will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W), and participants weighing less than (<) 30 kg will receive tocilizumab 12 mg/kg IV infusion Q2W for 52 weeks. After Week 12, the dose of tocilizumab can be adjusted for non-transient changes in body weight (shifting from <30 to >/=30 kg) over a minimum of three consecutive dosing visits. MTX, NSAIDs, and oral corticosteroids (CSs) are permitted but not required during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab will be administered as per the schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (JIA ACR30) Response With Absence of Fever, at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving JIA ACR30 Response With Absence of Fever, at Week 52 | Week 52 | |
| Percentage of Participants With 30 Percent (%), 50%, 70%, and 90% Improvement From Baseline in JIA Core Set Parameters | Baseline, Weeks 12, 24, and 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Institute of Pediatrics | Beijing | 100020 | China | |||
| Beijing Children's Hospital, Capital Medical University; rheumatism |
Not provided
| ID | Term |
|---|---|
| D001171 | Arthritis, Juvenile |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502936 | tocilizumab |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| NSAIDs | Drug | Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID. |
|
| CSs | Drug | Participants may receive CSs at a stable dose of 30 milligrams per day (mg/day) or 0.5 milligrams per kilogram per day (mg/kg/day), whichever is less. Study protocol does not enforce any particular CS. |
|
| MTX | Drug | Participants may receive MTX at a stable dose of less than or equal to (\ |
|
| Percentage of Participants With Inactive Disease Assessed According to Criteria for Inactive Disease and Clinical Remission of sJIA (Wallace et. al. 2011 Criteria) | Weeks 24 and 52 |
| Percentage of Participants With Clinical Remission Assessed According to Criteria for Inactive Disease and Clinical Remission of sJIA (Wallace et. al. 2011 Criteria) | Week 52 |
| Percentage of Participants With an Elevated High-Sensitivity C-Reactive Protein (hsCRP) Levels at Baseline Who Have Normal hsCRP Levels at Weeks 12, 24, and 52 | Baseline, Weeks 12, 24, and 52 |
| Mean Glucocorticoid Dose | Baseline up to Week 52 |
| Mean Methotrexate (MTX) Dose | Baseline up to Week 52 |
| Change From Baseline in Glucocorticoid Dose | From Baseline to Week 52 |
| Change From Baseline in MTX Dose | From Baseline to Week 52 |
| Pain Visual Analog Scale (VAS) Score | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Pain VAS Score | Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Percentage of Participants Who Discontinue Permitted Concomitant Medication for sJIA | Baseline up to Week 52 |
| Percentage of Participants With Adverse Events (AEs) | Baseline up to end of study (up to Week 60) |
| Beijing |
| 100045 |
| China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| Children's Hospital Chongqing Medical university | Chongqing | 400014 | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Pediatric Rheumatology division | Guangzhou | 510120 | China |
| The Children's Hospibal ZheJiang University School of Medicine | Hangzhou | 310052 | China |
| Chilren's hospital of nanjing medical university; Rheumatoid immunology | Nanjing | 210000 | China |
| Shanghai Children's Medical Center; Renal rheumatology | Shanghai | 200127 | China |
| Children's Hospital of Fudan University | Shanghai | 201102 | China |
| The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College | Wenzhou | 325000 | China |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |