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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00642460
First received: March 19, 2008
Last updated: December 18, 2012
Last verified: December 2012
Results First Received: September 16, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Juvenile Idiopathic Arthritis
Interventions: Drug: tocilizumab [RoActemra/Actemra]
Drug: Placebo
Drug: Non-steroidal anti-inflammatory drugs (NSAIDs)
Drug: methotrexate
Drug: corticosteroids

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

This study consists of 3 parts. Part I: a 12 week double-blind placebo controlled study followed by Part II: a 92 week single arm open-label extension study followed by Part III: a 3 year open label continuation study.

Data is only available for Part I and Part II.


Reporting Groups
  Description
Tocilizumab_8 mg/kg

Tocilizumab 8 mg/kg (for patients ≥30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.

Tocilizumab_12 mg/kg

Tocilizumab 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part I and every 2 weeks for 92 weeks in Part II.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Placebo Placebo iv every 2 weeks for 12 weeks in Part 1. Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.
Tocilizumab Switchers

Tocilizumab Switchers includes all participants who changed their dose either Tocilizumab 8 mg/kg or 12 mg/kg intravenous (iv) every 2 weeks in Part II.

Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.


Participant Flow for 2 periods

Period 1:   Part I: 12 Week Double-Blind
    Tocilizumab_8 mg/kg     Tocilizumab_12 mg/kg     Placebo     Tocilizumab Switchers  
STARTED     37     38     37     0  
Part I : Intent-to-treat     37     38     37     0  
COMPLETED     36     37     36     0  
NOT COMPLETED     1     1     1     0  
Adverse Event                 0                 1                 1                 0  
Refused Treatment                 1                 0                 0                 0  

Period 2:   Part II: Open-Label Up to Week 92
    Tocilizumab_8 mg/kg     Tocilizumab_12 mg/kg     Placebo     Tocilizumab Switchers  
STARTED     52 [1]   40     0 [2]   20 [3]
Part II: Intent-to-treat     52     40     0     20  
COMPLETED     43     32     0     17  
NOT COMPLETED     9     8     0     3  
Adverse Event                 4                 2                 0                 0  
Death                 0                 1                 0                 2  
Insufficient therapeutic response                 2                 3                 0                 0  
Refused treatment                 3                 1                 0                 0  
Failure to return                 0                 1                 0                 0  
Administrative reasons                 0                 0                 0                 1  
[1] Includes Participants who received Open-Label in Part II or Open-Label escape therapy in Part I.
[2] Placebo group received open-label Tocilizumab 8 mg/kg or 12 mg/kg based on body weight in Part II.
[3] 19 Participants switched from 12 mg/kg to 8 mg/kg and 1 Participant switched from 8mg/kg to 12 mg/kg



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tocilizumab

Tocilizumab 8 mg/kg (for patients ≥30 kg) or 12 mg/kg (for patients <30 kg) intravenous (iv) every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with non-steroidal anti-inflammatory drugs (NSAIDs), methotrexate and corticosteroids if applicable.

Placebo

Placebo iv every 2 weeks for 12 weeks in Part 1.

Participants remained on their prescribed standard of care treatment with NSAIDs, methotrexate and corticosteroids if applicable.

Total Total of all reporting groups

Baseline Measures
    Tocilizumab     Placebo     Total  
Number of Participants  
[units: participants]
  75     37     112  
Age, Customized  
[units: years]
     
2 to 5     16     11     27  
6 to 12     33     15     48  
13 to 17     26     11     37  
Gender  
[units: participants]
     
Female     39     17     56  
Male     36     20     56  



  Outcome Measures
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1.  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   [ Time Frame: Baseline, Week 12 ]

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

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

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

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

9.  Secondary:   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 ]

10.  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   [ Time Frame: Baseline, Week 12 ]

11.  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   [ Time Frame: Baseline, Week 12 ]

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

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

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

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

16.  Secondary:   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 ]

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

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

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

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

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

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

23.  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   [ Time Frame: 104 Weeks ]

24.  Primary:   Part I, II + III: Safety: Incidence of Adverse Events   [ Time Frame: 260 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2015   Safety Issue:   No

25.  Secondary:   Immunogenicity: Anti-tocilizumab Antibodies (HAHA)   [ Time Frame: 260 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2015   Safety Issue:   No

26.  Secondary:   Concomitant Medication Reduction (Corticosteroids, Methotrexate, NSAIDs)   [ Time Frame: 260 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2015   Safety Issue:   No

27.  Secondary:   Duration of Response (Inactive Disease, Clinical Remission)   [ Time Frame: 260 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

This study consists of 3 parts:

Part I: a 12 week double-blind placebo controlled study is complete.

Part II: a 92 week single arm open-label extension study- CSR completed Dec. 2011.

Part III: a 3 year open label continuation study is ongoing.



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00642460     History of Changes
Other Study ID Numbers: WA18221, 2007-000872-18
Study First Received: March 19, 2008
Results First Received: September 16, 2011
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration