A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00642460
• Date of registration: 19/03/2008
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
• Scientific 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
• Date of first enrolment: May 2008
• Target sample size: 112
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00642460
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Italy, Mexico, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis

Intervention(s)

Drug: Non-steroidal anti-inflammatory drugs (NSAIDs)

Drug: Placebo

Drug: corticosteroids

Drug: tocilizumab [RoActemra/Actemra]

Drug: methotrexate

Primary Outcome(s)

Part I: Percentage of Participants With =30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever [Time Frame: Baseline, Week 12]

Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104 [Time Frame: Baseline, Week 104]

Secondary Outcome(s)

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 [Time Frame: Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260]

Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits [Time Frame: Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260]

Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12 [Time Frame: Baseline, Week 12]

Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12 [Time Frame: Baseline, Week 12]

Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12 [Time Frame: Baseline, Week 12]

Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104 [Time Frame: Baseline, Week 104]

Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260 [Time Frame: Every 2 weeks from Week 104 to 260]

Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week [Time Frame: Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260]

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 [Time Frame: Baseline, Week 12]

Part II: Percentage of Participants With Inactive Disease at Week 104 [Time Frame: Week 104]

Part II: Percentage of Participants With no Active Joints at Week 104 [Time Frame: Week 104]

Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being [Time Frame: Baseline, Week 12]

Part III: Doses of Oral Corticosteroids [Time Frame: Baseline and Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260]

Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions. [Time Frame: Every 2 weeks from Week 104 to 260]

Part I: Percentage of Participants With Concomitant Corticosteroid Reduction [Time Frame: Week 6 or Week 8, Week 12]

Part I: Percentage of Patients With Anemia at Baseline With a =10 g/L Increase in Hemoglobin at Week 6 and Week 12 [Time Frame: Baseline, Week 6 and Week 12]

Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits [Time Frame: Every 2 weeks from Week 104 to Week 260]

Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104 [Time Frame: Baseline, Week 104]

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 [Time Frame: 104 Weeks]

Part III: Percentage of Participants in Clinical Remission [Time Frame: Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260]

Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits [Time Frame: Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260]

Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12 [Time Frame: Baseline, Week 12]

Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104 [Time Frame: Baseline, Week 104]

Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits [Time Frame: Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260]

Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR [Time Frame: Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260]

Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI) [Time Frame: Baseline, Week 12]

Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis [Time Frame: Baseline, Week 12]

Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity [Time Frame: Baseline, Week 12]

Part II: Number of Active Joints at Week 104 [Time Frame: Week 104]

Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate [Time Frame: Baseline, Week 12]

Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement [Time Frame: Baseline, Week 12]

Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12 [Time Frame: Baseline, Week 12]

Part III: Percentage of Participants With Inactive Disease [Time Frame: Weeks 104, 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260]

Secondary ID(s)

WA18221

2007-000872-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/10/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00642460