Clinical trial NCT01673919: A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study
Official title: Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From France Who Completed the Global, Multinational Trial (WA19977)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 7
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 will continue to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients who completed visit 33 (week 104) of WA19977 study and who may benefit from study drug treatment according to the investigator's assessment
* Patients have to receive the first RoActemra/Actemra infusion in this study at the Week 8 visit at the latest
* 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
* Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course Juvenile Idiopathic Arthritis (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
* Any infections with contraindications to RoActemra/Actemra therapy according to investigator judgment
* Inadequate hepatic, renal or bone marrow function

Primary outcomes:
measure: Number of Participants With Any Adverse Events and Any Serious Adverse Events
timeFrame: Approximately 2 years
measure: Number of Participants With Adverse Events of Special Interest
timeFrame: Approximately 2 years
measure: Number of Participants With Adverse Events Related to Tocilizumab
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Mean Exposure to Study Treatment
timeFrame: Approximately 2 years
measure: Mean Duration of Study Follow-Up
timeFrame: Approximately 2 years
measure: Number of Participants With AEs Leading to TCZ Modification, AEs Leading to Death, Anaphylaxis or Serious Hypersensitivity and Deaths
timeFrame: Approximately 2 years
measure: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
timeFrame: Approximately 2 years
measure: Number of Participants With Abnormality in Physical Examinations
timeFrame: Approximately 2 years
measure: Number of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology Response 50/70
timeFrame: Weeks 12, 24, 36, 48, 60, 72, 84, and 108
measure: Number of Participants With Inactive Disease
timeFrame: Weeks 24, 36, 48, 72, and 108
measure: Number of Participants Achieving Clinical Remission
timeFrame: Weeks 24, 36, 48, 72, and 108
measure: Number of Participants With a Minimally Important Improvement in the Childhood Health Assessment Questionnaire-Disability Index
timeFrame: Weeks 12, 24, 36, 48, 60, 72, 84, and 108
measure: Number of Joints With Limitation of Motion
timeFrame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108
measure: Number of Joints With Active Range of Motion
timeFrame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108
measure: Number of Swollen Joints
timeFrame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108
measure: Number of Painful Joints
timeFrame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108
measure: Physician's Global Assessment of Disease Activity
timeFrame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108
measure: Parent/Patient's Global Assessment of Disease Activity
timeFrame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108
measure: Parent/Patient's Discomfort Index (Pain)
timeFrame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60, 72, 84, and 108
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
city: Montpellier
country: France
city: Paris
country: France
city: Paris
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: