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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01575769
First received: April 10, 2012
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

This long-term, interventional, open-label extension study will evaluate the saf ety 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. T he 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:


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 ]

Enrollment: 41
Study Start Date: March 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575769

Locations
Poland
Bydgoszcz, Poland, 85-667
Kraków, Poland, 31-503
Lodz, Poland, 91-738
Lublin, Poland, 20-093
Sosnowiec, Poland, 41-218
Russian Federation
Moscow, Russian Federation, 119991
Moscow, Russian Federation, 115522
Rostov-na-donu, Russian Federation, 344022
Saint-Petersburg, Russian Federation, 194100
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: November 24, 2014
Health Authority: Poland: Ministry of Health

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

ClinicalTrials.gov processed this record on November 25, 2014