Phase 3
N=112
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00642460 ↗Enrolled (actual)
112
Serious AEs
42.9%
Results posted
Oct 2011
Primary outcome: Primary: Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever — 85.3; 24.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tocilizumab [RoActemra/Actemra] (Drug); Placebo (Drug); Non-steroidal anti-inflammatory drugs (NSAIDs) (Drug); methotrexate (Drug); corticosteroids (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part I: Percentage of Participants With ≥30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever |
85.3; 24.3 | — |
| PRIMARY Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104 |
76; 73; 62; 47 | — |
| SECONDARY Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12 |
90.7; 24.3; 85.3; 10.8; 70.7; 8.1 | — |
| SECONDARY Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity |
-69.6; -41.1 | — |
| SECONDARY Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being |
-65.8; -1.4 | — |
| SECONDARY Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis |
-70.6; -37.2 | — |
| SECONDARY Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement |
-51.6; -22.5 | — |
| SECONDARY Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate |
-88.2; 33.6 | — |
| SECONDARY Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI) |
-45.6; -10.3 | — |
| SECONDARY Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12 |
85.4; 20.8 | — |
| SECONDARY Part I: Percentage of Participants With Changes in Laboratory Indicators: High-sensitivity C-Reactive Protein(hsCRP), Hemoglobin (Hb), Platelets and Leukocytes From Abnormal at Baseline to Normal at Week 12 |
98.6; 5.9; 80.0; 6.9; 90.4; 3.8 | — |
| SECONDARY Part I: Percentage of Participants With Concomitant Corticosteroid Reduction |
24.3; 3.2 | — |
| SECONDARY Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12 |
-41.0; -1.1 | — |
| SECONDARY Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12 |
77.3; 18.9 | — |
| SECONDARY Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12 |
63.6; 11.1 | — |
| SECONDARY Part I: Percentage of Patients With Anemia at Baseline With a ≥10 g/L Increase in Hemoglobin at Week 6 and Week 12 |
88.0; 3.4; 88.0; 3.4 | — |
| SECONDARY Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104 |
76.0; 61.3 | — |
| SECONDARY Part II: Number of Active Joints at Week 104 |
1.9 | — |
| SECONDARY Part II: Percentage of Participants With no Active Joints at Week 104 |
47.4 | — |
| SECONDARY Part II: Percentage of Participants With Inactive Disease at Week 104 |
26.7 | — |
| SECONDARY Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104 |
1.68; 0.55 | — |
| SECONDARY Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104 |
60 | — |
| SECONDARY Part II: Rate of Serious Adverse Events (SAEs), Serious Infection Adverse Events (AEs), Related SAEs, Macrophage Activation Syndrome, AEs Leading to Withdrawal and Deaths Per 100 Patient Years to Week 104 |
23.3; 10.9; 7.4; 1.5; 3.0; 1.5 | — |
| SECONDARY Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR |
100.0; 100.0; 100.0; 100.0; 92.9; 95.7 | — |
| SECONDARY Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Part III: Doses of Oral Corticosteroids |
0.203; 0.356; 0.020; 0.047; 0.022; 0.046 | — |
| SECONDARY Part III: Percentage of Participants on Corticosteroids at Baseline Able to Discontinue Corticosteroids by Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260 |
66.0; 67.0; 67.0; 68.0; 69.0; 70.0 | — |
| SECONDARY Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits |
100.0; 97.8; 94.7; 91.3; 84.2; 82.6 | — |
| SECONDARY Part III: Percentage of Participants With Inactive Disease |
45.2; 46.8; 48.8; 43.5; 55.0; 48.8 | — |
| SECONDARY Part III: Percentage of Participants in Clinical Remission |
14.6; 17.4; 32.5; 23.3; 34.2; 25.0 | — |
| SECONDARY Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits |
12.2; 17.4; 32.5; 20.9; 28.9; 20.0 | — |
| SECONDARY Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits |
7.3; 8.7; 20.0; 11.6; 18.4; 5.0 | — |
| SECONDARY Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits |
4.9; 8.7; 15.0; 9.3; 15.8; 5.0 | — |
| SECONDARY Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260 |
0.0; 0.0 | — |
| SECONDARY Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions. |
0.0; 0.0 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients aged 2-17 years of age
- Systemic juvenile idiopathic arthritis with >= 6 months persistent activity
- Presence of active disease (>=5 active joints, or >=2 active joints + fever + steroids)
- Inadequate clinical response to nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids due to toxicity or lack of efficacy
Exclusion Criteria
- Wheelchair-bound or bed-ridden
- Any other autoimmune, rheumatic disease or overlap syndrome other than systemic juvenile idiopathic arthritis
- Intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study
- Disease-modifying antirheumatic drugs (DMARDs), other than methotrexate
- Previous treatment with tocilizumab
Data sourced from ClinicalTrials.gov (NCT00642460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.