Back to resultsAn Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
tocilizumab [RoActemra/Actemra]
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis
Eligibility Criteria
Inclusion Criteria:
- Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment
- Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria:
- Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
- Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or current participation in another clinical trial except WA19977
- Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
- Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
- Any significant concomitant disease or medical or surgical condition
- History of significant allergic or infusion reactions to prior biologic therapy
- Currently active primary or secondary immunodeficiency
- Current abuse of alcohol, drugs or chemical abuse
- Known and currently active acute, subacute, chronic infections or history of recurrent infection; patients suffering from ongoing active infections with Epstein Barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided
- Positive for latent tuberculosis (TB)
- Currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for >/= 2 weeks within 6 months prior to entering the study
- Inadequate hepatic, renal or bone marrow function
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RoActemra/Actemra
Arm Description
Outcomes
Primary Outcome Measures
Long-term safety: Incidence of adverse events
Secondary Outcome Measures
Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR)
Proportion of patients achieving inactive disease/clinical remission
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01727986
Brief Title
An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study
Official Title
Extension, Open-label, Interventional, Long-term Study to Evaluate the Safety of Tocilizumab Treatment in Patients From Brazil With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global Multinational Trial (WA19977)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
None (Open Label)
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RoActemra/Actemra
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks
Primary Outcome Measure Information:
Title
Long-term safety: Incidence of adverse events
Time Frame
approximately 3 years
Secondary Outcome Measure Information:
Title
Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR)
Time Frame
approximately 3 years
Title
Proportion of patients achieving inactive disease/clinical remission
Time Frame
approximately 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment
Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria:
Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
Treatment with any investigational agent since the last administration of study drug in the core study WA19977 or current participation in another clinical trial except WA19977
Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
Any significant concomitant disease or medical or surgical condition
History of significant allergic or infusion reactions to prior biologic therapy
Currently active primary or secondary immunodeficiency
Current abuse of alcohol, drugs or chemical abuse
Known and currently active acute, subacute, chronic infections or history of recurrent infection; patients suffering from ongoing active infections with Epstein Barr virus, herpes zoster or recurrent history of urinary tract infection can be included after the (acute) infection has been excluded or subsided
Positive for latent tuberculosis (TB)
Currently active asthma for which the patient has required the use of oral or parenteral corticosteroids for >/= 2 weeks within 6 months prior to entering the study
Inadequate hepatic, renal or bone marrow function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Rio de janeiro
State/Province
RJ
ZIP/Postal Code
20551030
Country
Brazil
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-912
Country
Brazil
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study
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