A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01673919
First received: August 23, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This long-term, open-label extension study will evaluate the safety of RoActemra

/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients will continue to recei ve RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on st udy treatment is 104 weeks.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: tocilizumab [RoActemra/Actemra]
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 France 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: approximately 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Proportion of patients achieving inactive disease/clinical remission [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: February 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra/Actemra Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 104 weeks

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who completed visit 33 (week 104) of WA19977 study and who may benefit from study drug treatment according to the investigator's assessment
  • Patients have to receive the first RoActemra/Actemra infusion in this study at the Week 8 visit at the latest
  • Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

  • Patients with, according to investigator judgment, not satisfactory benefit from RoActemra/Actemra therapy within WA19977
  • Treatment with any investigational agent since the last administration of study drug in the core study WA19977
  • Patient developed any other autoimmune rheumatic disease or overlap syndrome other than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or negative JIA or extended oligoarticular JIA
  • Patient is pregnant , lactating, or intending to become pregnant during the study and up to 12 weeks after the last administration of study drug
  • Any significant concomitant disease or medical or surgical condition
  • History of significant allergic or infusion reactions to prior biologic therapy
  • Currently active primary or secondary immunodeficiency
  • Any infections with contraindications to RoActemra/Actemra therapy according to investigator judgment
  • Inadequate hepatic, renal or bone marrow function
  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: NCT01673919

Locations
France
Le Kremlin Bicêtre, France, 94275
Montpellier, France, 34295
Paris, France, 75743
Paris, France, 75679
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: NCT01673919     History of Changes
Other Study ID Numbers: ML28166, 2011-005515-90
Study First Received: August 23, 2012
Last Updated: July 7, 2014
Health Authority: France: Agence Nationale de Sécurite du Médicament et des Produits de Santé - ANSM

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 July 22, 2014