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

Juvenile Idiopathic Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673919
• Other study ID #: ML28166
• Secondary ID: 2011-005515-90
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2012
• Last updated: November 2, 2015
• Start date: February 2012
• Est. completion date: January 2014

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurite du Médicament et des Produits de Santé - ANSM
• Study type: Interventional

Clinical Trial Summary

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 receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 104 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term safety: Incidence of adverse events		approximately 2 years	No
Secondary	Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR)		approximately 2 years	No
Secondary	Proportion of patients achieving inactive disease/clinical remission		approximately 2 years	No