Phase 3
N=7
A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study
Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01673919 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Number of Participants With Any Adverse Events and Any Serious Adverse Events — 7; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- tocilizumab [RoActemra/Actemra] (Drug)
- Age
- Pediatric, Adult, Older Adult · 4+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Any Adverse Events and Any Serious Adverse Events |
7; 0 | — |
| PRIMARY Number of Participants With Adverse Events of Special Interest |
2; 2; 1; 1; 1; 1 | — |
| PRIMARY Number of Participants With Adverse Events Related to Tocilizumab |
5; 2; 1 | — |
| SECONDARY Mean Exposure to Study Treatment |
17.08 | — |
| SECONDARY Mean Duration of Study Follow-Up |
21.08 | — |
| SECONDARY Number of Participants With AEs Leading to TCZ Modification, AEs Leading to Death, Anaphylaxis or Serious Hypersensitivity and Deaths |
2; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormal Laboratory Parameters |
1; 1; 1; 2 | — |
| SECONDARY Number of Participants With Abnormality in Physical Examinations |
1; 1; 1; 1; 3 | — |
| SECONDARY Number of Participants With Juvenile Idiopathic Arthritis American College of Rheumatology Response 50/70 |
1; 2; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Inactive Disease |
1; 1; 1; 1; 1 | — |
| SECONDARY Number of Participants Achieving Clinical Remission |
1; 5; 1; 1; 1 | — |
| SECONDARY Number of Participants With a Minimally Important Improvement in the Childhood Health Assessment Questionnaire-Disability Index |
5; 5; 6; 5; 6; 2 | — |
| SECONDARY Number of Joints With Limitation of Motion |
11.4; 9.4; 6.7; 8.1; 8.6; 10.3 | — |
| SECONDARY Number of Joints With Active Range of Motion |
2.3; 1.4; 2.2; 1.3; 2.0; 2.0 | — |
| SECONDARY Number of Swollen Joints |
1.6; 1.0; 1.0; 0.9; 1.9; 1.7 | — |
| SECONDARY Number of Painful Joints |
1.9; 0.6; 2.0; 0.7; 0.9; 0.7 | — |
| SECONDARY Physician's Global Assessment of Disease Activity |
8.6; 4.2; 9.3; 6.7; 3.7; 4.0 | — |
| SECONDARY Parent/Patient's Global Assessment of Disease Activity |
14.9; 8.0; 12.7; 3.9; 10.1; 7.4 | — |
| SECONDARY Parent/Patient's Discomfort Index (Pain) |
15.0; 5.6; 7.7; 3.0; 12.9; 6.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT01673919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.