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An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01575769
First received: April 10, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
 Drug: RoActemra/Actemra (tocilizumab)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Long-term Safety: Incidence of adverse events [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with juvenile idiopathic arthritis (JIA) American College of Rheumatology (ACR) response [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with inactive disease at visits [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with clinical remission at visits [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with improvements in Childhood Health Assessment Questionnaire [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RoActemra/Actemra (tocilizumab)
Tocilizumab 8 mg/kg every 4 weeks for 104 weeks

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575769

Contacts
Contact: Please reference Study ID Number: ML27783 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Locations
Poland
Recruiting
Bydgoszcz, Poland, 85-667
Active, not recruiting
Kraków, Poland, 31-503
Active, not recruiting
Lodz, Poland, 91-738
Active, not recruiting
Lublin, Poland, 20-093
Active, not recruiting
Sosnowiec, Poland, 41-218
Russian Federation
Active, not recruiting
Moscow, Russian Federation, 119991
Active, not recruiting
Moscow, Russian Federation, 115522
Active, not recruiting
Rostov-na-donu, Russian Federation, 344022
Active, not recruiting
Saint-petersburg, Russian Federation, 194100
Active, not recruiting
Samara, Russian Federation, 443070
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01575769     History of Changes
Other Study ID Numbers: ML27783
Study First Received: April 10, 2012
Last Updated: May 7, 2013
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013