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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00642460




Registration number
NCT00642460
Ethics application status
Date submitted
19/03/2008
Date registered
25/03/2008
Date last updated
25/07/2016

Titles & IDs
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
Secondary ID [1] 0 0
2007-000872-18
Secondary ID [2] 0 0
WA18221
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tocilizumab [RoActemra/Actemra]
Treatment: Drugs - Placebo
Treatment: Drugs - Non-steroidal anti-inflammatory drugs (NSAIDs)
Treatment: Drugs - methotrexate
Treatment: Drugs - corticosteroids

Experimental: 1 -

Placebo comparator: 2 -


Treatment: Drugs: tocilizumab [RoActemra/Actemra]
8mg/kg (patients\>=30kg) or 12mg/kg (patients \<30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.

Treatment: Drugs: Placebo
iv every 2 weeks for 12 weeks

Treatment: Drugs: Non-steroidal anti-inflammatory drugs (NSAIDs)
as prescribed

Treatment: Drugs: methotrexate
as prescribed

Treatment: Drugs: corticosteroids
orally, as prescribed
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part I: Percentage of Participants With =30% Improvement in Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Core Set and Absence of Fever
Timepoint [1] 0 0
Baseline, Week 12
Primary outcome [2] 0 0
Part II: Percentage of Participants With Decreases in Oral Corticosteroid Dose at Week 104
Timepoint [2] 0 0
Baseline, Week 104
Secondary outcome [1] 0 0
Part I: Percentage of Participants With JIA Core Set ACR 30/50/70/90 Response at Week 12
Timepoint [1] 0 0
Baseline, Week 12
Secondary outcome [2] 0 0
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Physician's Global Assessment of Disease Activity
Timepoint [2] 0 0
Baseline, Week 12
Secondary outcome [3] 0 0
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Parent/Patient Global Assessment of Overall Well-being
Timepoint [3] 0 0
Baseline, Week 12
Secondary outcome [4] 0 0
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Maximum Number of Joints With Active Arthritis
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Number of Joints With Limitation of Movement
Timepoint [5] 0 0
Baseline, Week 12
Secondary outcome [6] 0 0
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Erythrocyte Sedimentation Rate
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Part I: Percentage Change From Baseline in JIA Core Set ACR Score Component: Childhood Health Assessment Questionnaire Disability Index (CHAQ-DI)
Timepoint [7] 0 0
Baseline, Week 12
Secondary outcome [8] 0 0
Part I: Percentage of Participants With Fever Due to Systemic Juvenile Idiopathic Arthritis (sJIA) at Baseline Who Are Free of Fever at Week 12
Timepoint [8] 0 0
Baseline, Week 12
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Part I: Percentage of Participants With Concomitant Corticosteroid Reduction
Timepoint [10] 0 0
Week 6 or Week 8, Week 12
Secondary outcome [11] 0 0
Part I: Change From Baseline in the Pain Visual Analog Scale (VAS) at Week 12
Timepoint [11] 0 0
Baseline, Week 12
Secondary outcome [12] 0 0
Part I: Percentage of Patients With Minimally Important Improvement in CHAQ-DI Score at Week 12
Timepoint [12] 0 0
Baseline, Week 12
Secondary outcome [13] 0 0
Part I: Percentage of Patients With Rash at Baseline Who Are Free From Rash at Week 12
Timepoint [13] 0 0
Baseline, Week 12
Secondary outcome [14] 0 0
Part I: Percentage of Patients With Anemia at Baseline With a =10 g/L Increase in Hemoglobin at Week 6 and Week 12
Timepoint [14] 0 0
Baseline, Week 6 and Week 12
Secondary outcome [15] 0 0
Part II: Percentage of Participants With JIA ACR70 and JIA ACR90 Responses Week 104
Timepoint [15] 0 0
Baseline, Week 104
Secondary outcome [16] 0 0
Part II: Number of Active Joints at Week 104
Timepoint [16] 0 0
Week 104
Secondary outcome [17] 0 0
Part II: Percentage of Participants With no Active Joints at Week 104
Timepoint [17] 0 0
Week 104
Secondary outcome [18] 0 0
Part II: Percentage of Participants With Inactive Disease at Week 104
Timepoint [18] 0 0
Week 104
Secondary outcome [19] 0 0
Part II: Childhood Health Assessment Questionnaire-Disability Index (CHAQ-DI) Score at Week 104
Timepoint [19] 0 0
Baseline, Week 104
Secondary outcome [20] 0 0
Part II: Percentage of Participants With Oral Corticosteroid Cessation at Week 104
Timepoint [20] 0 0
Baseline, Week 104
Secondary outcome [21] 0 0
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
Timepoint [21] 0 0
104 Weeks
Secondary outcome [22] 0 0
Part III: Percentage of Participants With at Least 30%, 50%, 70%, and 90% Improvement in JIA Core Set According to ACR
Timepoint [22] 0 0
Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260
Secondary outcome [23] 0 0
Part III: Percentage of Participants Who Maintain JIA ACR30, JIA ACR50, JIA ACR70, JIA ACR90 Response for 6 Months Previous to the Specified Week
Timepoint [23] 0 0
Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260
Secondary outcome [24] 0 0
Part III: Doses of Oral Corticosteroids
Timepoint [24] 0 0
Baseline and Weeks 104, 116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248 and 260
Secondary outcome [25] 0 0
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
Timepoint [25] 0 0
Weeks 104,116, 128, 140, 152, 164, 176, 188, 200, 212, 224, 236, 248, and 260
Secondary outcome [26] 0 0
Part III: Percentage of Participants With a >=20/50/75/90% Decrease From Baseline in Oral Corticosteroid Dose at Visits
Timepoint [26] 0 0
Every 2 weeks from Week 104 to Week 260
Secondary outcome [27] 0 0
Part III: Percentage of Participants With Inactive Disease
Timepoint [27] 0 0
Weeks 104, 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Secondary outcome [28] 0 0
Part III: Percentage of Participants in Clinical Remission
Timepoint [28] 0 0
Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Secondary outcome [29] 0 0
Part III: Percentage of Participants on Corticosteroids at Baseline in Clinical Remission Off All Oral Corticosteroids for 6 Months Prior to Specified Visits
Timepoint [29] 0 0
Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Secondary outcome [30] 0 0
Part III: Percentage of Participants on Methotrexate At Baseline in Clinical Remission Off Corticosteroids and Methotrexate for 6 Months Prior to Specified Visits
Timepoint [30] 0 0
Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Secondary outcome [31] 0 0
Part III: Percentage of Participants in Clinical Remission Off All Arthritis Medications Except Tocilizumab for 6 Months Prior to Specified Visits
Timepoint [31] 0 0
Weeks 116, 128, 140, 152, 164, 188, 200, 212, 224,236,248 and 260
Secondary outcome [32] 0 0
Part III: Percentage of Participants Who Developed Antibodies To Tocilizumab During Weeks 104 to 260
Timepoint [32] 0 0
Every 2 weeks from Week 104 to 260
Secondary outcome [33] 0 0
Part III: Percentage of Participants Who Developed Anti-TCZ Antibodies Associated With The Occurrence of Drug Hypersensitivity Reactions.
Timepoint [33] 0 0
Every 2 weeks from Week 104 to 260

Eligibility
Key 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
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2014
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Parkville
Recruitment hospital [2] 0 0
- Subiaco
Recruitment hospital [3] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
6008 - Subiaco
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
La Plata
Country [14] 0 0
Belgium
State/province [14] 0 0
Gent
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Brazil
State/province [16] 0 0
Porto Alegre
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio de Janeiro
Country [18] 0 0
Brazil
State/province [18] 0 0
Sao Paulo
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Czech Republic
State/province [22] 0 0
Praha
Country [23] 0 0
Denmark
State/province [23] 0 0
Copenhagen
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Bremen
Country [26] 0 0
Germany
State/province [26] 0 0
Sankt Augustin
Country [27] 0 0
Greece
State/province [27] 0 0
Athens
Country [28] 0 0
Greece
State/province [28] 0 0
Heraklion
Country [29] 0 0
Greece
State/province [29] 0 0
Ioannina
Country [30] 0 0
Italy
State/province [30] 0 0
Genova
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Padova
Country [33] 0 0
Italy
State/province [33] 0 0
Roma
Country [34] 0 0
Mexico
State/province [34] 0 0
Mexico
Country [35] 0 0
Mexico
State/province [35] 0 0
Miexico City
Country [36] 0 0
Netherlands
State/province [36] 0 0
Utrecht
Country [37] 0 0
Norway
State/province [37] 0 0
Oslo
Country [38] 0 0
Poland
State/province [38] 0 0
Kraków
Country [39] 0 0
Poland
State/province [39] 0 0
Lublin
Country [40] 0 0
Slovakia
State/province [40] 0 0
Piestany
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Esplugas de Llobregat
Country [43] 0 0
Spain
State/province [43] 0 0
Madrid
Country [44] 0 0
Spain
State/province [44] 0 0
Valencia
Country [45] 0 0
Sweden
State/province [45] 0 0
Goeteborg
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Liverpool
Country [47] 0 0
United Kingdom
State/province [47] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00642460