NCT01575769

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
2 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2013

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 7, 2016

Completed
Last Updated

February 9, 2018

Status Verified

August 1, 2017

Enrollment Period

1.9 years

First QC Date

April 10, 2012

Results QC Date

August 17, 2015

Last Update Submit

August 2, 2017

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Adverse Events (AEs)

    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.

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

Secondary Outcomes (22)

  • 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)

  • 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)

  • 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)

  • +17 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: RoActemra/Actemra (tocilizumab)

Interventions

RoActemra/Actemra (tocilizumab)DRUG

Tocilizumab 8 mg/kg every 4 weeks for 104 weeks

1

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Wojewodzki Szpital Dzieciecy Im. J. Brudzinskiego

Bydgoszcz, 85-667, Poland

Location

Wojewodzki Specjalistyczny Szpital Dzieciecy Sw Ludwika; Oddzial Dzieci Starszych

Krakow, 31-503, Poland

Location

Uniwersytecki Szpital Kliniczny Nr 4 im. M. Konopnickiej; Oddz. Kardiolog. i Reumatolog. dla Dzieci

Lodz, 91-738, Poland

Location

Dzieciecy Szpital Kliniczny IM. Prof. A. Gebali; Oddzial Pediatrii Chorob Pluc I Reumatologii

Lublin, 20-093, Poland

Location

Centrum Pediatrii im Jana Pawla II; Oddzial Reumatologiczny

Sosnowiec, 41-218, Poland

Location

Scientific Research Institute

Moscow, 115522, Russia

Location

SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

Moscow, 119021, Russia

Location

SI Sceintific children health center RAMS

Moscow, 119991, Russia

Location

GOU VPO Rostovskiy state medical university Roszdrav

Rostov-on-Don, 344022, Russia

Location

Saint-Petersburg State; Pediatrics Medical Academy

Saint Petersburg, 194100, Russia

Location

Samara Regional Clinical Cardiology Dispensary

Samara, 443070, Russia

Location

Related Publications (1)

  • Opoka-Winiarska V, Zuber Z, Alexeeva E, Chasnyk V, Nikishina I, Debowska G, Smolewska E. 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, international CHERISH trial. Clin Rheumatol. 2018 Jul;37(7):1807-1816. doi: 10.1007/s10067-018-4071-9. Epub 2018 Apr 13.

    PMID: 29654485DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

The study was terminated prior to the planned final on-treatment efficacy assessments due to commercial availability of tocilizumab in Russia and Poland.

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche or Genentech, Inc
genentech@druginfo.com
800 821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 11, 2012

Study Start

January 19, 2012

Primary Completion

December 3, 2013

Study Completion

December 3, 2013

Last Updated

February 9, 2018

Results First Posted

January 7, 2016

Record last verified: 2017-08

Locations

PL(5)RU(6)