Clinical trial NCT01575769: An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis
Official title: 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).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-04-11
Enrollment: 41
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline to 12 weeks after last actual study medication (up to 101 weeks)
Secondary outcomes:
measure: Percentage of Participants With JIA ACR 30 Response at Weeks 12, 24 and End of Follow Up
timeFrame: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)
measure: Percentage of Participants With JIA ACR 50 Response at Weeks 12, 24 and End of Follow up
timeFrame: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)
measure: Percentage of Participants With JIA ACR 70 Response at Weeks 12, 24 and End of Follow up
timeFrame: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)
measure: Percentage of Participants With JIA ACR 90 Response at Weeks 12, 24 and End of Follow up
timeFrame: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)
measure: Percentage of Participants With Inactive Disease at Week 12, 24 and End of Follow up
timeFrame: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)
measure: Percentage of Participants With Clinical Remission at Week 12, 24 and End of Follow up
timeFrame: Baseline, Week 12, 24, End of Follow up (up to 101 weeks)
measure: Change From Baseline in Joints With Active Arthritis at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in Number of Joints With Limitation of Movement at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in PGA of Disease Activity at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in PtGA of Overall Well-Being at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in ESR at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in Childhood Health Assessment - Disability Index (CHAQ-DI) at Weeks 12, 24, 36, 48, 60, 72, 84, End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: 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
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in CHAQ-DI (Activitiy) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in CHAQ-DI (Arising) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in CHAQ-DI (Dressing and Grooming) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in CHAQ-DI (Eating) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in CHAQ-DI (Grip) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in CHAQ-DI (Hygiene) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in CHAQ-DI (Reach) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Change From Baseline in CHAQ-DI (Walking) Score at Weeks 12, 24, 36, 48, 60, 72, 84 and End of Follow up
timeFrame: Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, End of follow up (up to 101 weeks)
measure: Absolute C-Reactive Protein Levels
timeFrame: 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)
Other outcomes:
Locations:
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Dzieciecy Im. J. Brudzinskiego
city: Kraków
country: Poland
facility: Wojewodzki Specjalistyczny Szpital Dzieciecy Sw Ludwika; Oddzial Dzieci Starszych
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 4 im. M. Konopnickiej; Oddz. Kardiolog. i Reumatolog. dla Dzieci
city: Lublin
country: Poland
facility: Dzieciecy Szpital Kliniczny IM. Prof. A. Gebali; Oddzial Pediatrii Chorob Pluc I Reumatologii
city: Sosnowiec
country: Poland
facility: Centrum Pediatrii im Jana Pawla II; Oddzial Reumatologiczny
city: Moscow
country: Russian Federation
facility: Scientific Research Institute
city: Moscow
country: Russian Federation
facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF
city: Moscow
country: Russian Federation
facility: SI Sceintific children health center RAMS
city: Rostov-na-donu
country: Russian Federation
facility: GOU VPO Rostovskiy state medical university Roszdrav
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State; Pediatrics Medical Academy
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Cardiology Dispensary
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.