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An 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
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
November 8, 2012
Last Updated
May 4, 2016
Sponsor
Hoffmann-La Roche
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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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