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Clinical Trials/NCT01575769
NCT01575769TerminatedPhase 3

Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From Poland and Russia Who Completed the Global, Multinational Trial (WA19977).

Hoffmann-La Roche11 sites in 2 countries41 target enrollmentStarted: January 19, 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
41
Locations
11
Primary Endpoint
Percentage of Participants With Adverse Events (AEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This long-term, interventional, open-label extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients from Poland and Russia with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 study. Patients will receive RoActemra/Actemra 8 mg/kg every 4 weeks. The anticipated time on study treatment is 104 weeks.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
2 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients who completed 104 weeks of study WA19977 with at least a JIA ACR30 clinical response to RoActemra/Actemra and no serious adverse event or adverse event
  • •Written informed consent obtained from patient if patient is 18 years of age and older, or if under the age of 18 years from parents or legal guardian

Exclusion Criteria

  • •Patient did not benefit from RoActemra/Actemra therapy in study WA19977
  • •Treatment with any investigational drug since the last administration of study drug in the core study WA19977
  • •Patients developed any other autoimmune rheumatic disease other than the permitted JIA subsets
  • •Any significant medical or surgical condition that would jeopardize patient's safety
  • •Current serious uncontrolled concomitant disease or infection

Arms & Interventions

1

Experimental

Intervention: RoActemra/Actemra (tocilizumab) (Drug)

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events (AEs)

Time Frame: Baseline to 12 weeks after last actual study medication (up to 101 weeks)

AE: unfavorable and unintended sign, symptom, or disease associated with use of treatment, regardless of treatment relation. Pre-existing conditions that worsened and laboratory or clinical tests that resulted in change in treatment or discontinuation from treatment were reported as AEs. Serious AE: resulted in death, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was congenital anomaly/birth defect or was medically significant. Severe AE: AE that caused inability to work or perform normal daily activity. AEs of special interest: Serious infections (including opportunistic infections), Myocardial infarction/Acute coronary syndrome, Gastrointestinal perforations and related AE, Malignant neoplasms, Anaphylaxis event, Demyelination-related events, Stroke, Spontaneous or serious bleeding, Serious/medically significant hepatic events. Any AE included serious and non-serious AE.

Secondary Outcomes

  • Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up(Baseline, Week 12, 24, End of Follow up (up to 101 weeks))
  • Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up(Baseline, Week 12, 24, End of Follow up (up to 101 weeks))
  • Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up(Baseline, Week 12, 24, End of Follow up (up to 101 weeks))
  • Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up(Baseline, Week 12, 24, End of Follow up (up to 101 weeks))
  • Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up(Baseline, Week 12, 24, End of Follow up (up to 101 weeks))
  • Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up(Baseline, Week 12, 24, End of Follow up (up to 101 weeks))
  • Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Percentage of Participants With Minimally Important Improvement in the CHAQ-DI Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up(Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks))
  • Absolute C-Reactive Protein Levels(Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, End of follow up (up to 101 weeks))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (11)

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