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

NCT01673919 | Completed Phase 3 Results

• 2 other identifiers: ML281662011-005515-90
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Any Adverse Events and Any Serious Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.

  Approximately 2 years

• Number of Participants With Adverse Events of Special Interest

  An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. The AEs of special interests included gingival bleeding, tooth abscess, acarodermatitis, ear infection, gastroenteritis, herpes zoster ophthalmic, lice infestation, nasopharyngitis, oral fungal infection, oral herpes, pharyngitis, rhinitis, sinusitis, tonsillitis, tracheitis, tracheobronchitis, urinary tract infection, menorrhagia, asthma, epistaxis, and hematoma.

  Approximately 2 years

• Number of Participants With Adverse Events Related to Tocilizumab

  An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. Relatedness of any AEs was reported as possibly related, probably related, or remotely related to TCZ.

  Approximately 2 years

Secondary Outcomes (16)

• Mean Exposure to Study Treatment

  Approximately 2 years

• Mean Duration of Study Follow-Up

  Approximately 2 years

• Number of Participants With AEs Leading to TCZ Modification, AEs Leading to Death, Anaphylaxis or Serious Hypersensitivity and Deaths

  Approximately 2 years

• Number of Participants With Clinically Significant Abnormal Laboratory Parameters

  Approximately 2 years

• Number of Participants With Abnormality in Physical Examinations

  Approximately 2 years

Study Arms (1)

RoActemra/Actemra

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

8 mg/kg iv every 4 weeks, 104 weeks

RoActemra/Actemra

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 Juvenile Idiopathic Arthritis (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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Unknown Facility

Le Kremlin-Bicêtre, 94275, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Paris, 75679, France

Location

Unknown Facility

Paris, 75743, France

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 61 6878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: February 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: September 12, 2025
• Results First Posted: November 2, 2016

Record last verified: 2025-08

Locations

FR (4)