A Study of RoActemra/Actemra (Tocilizumab) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01455701
First received: October 18, 2011
Last updated: March 16, 2015
Last verified: March 2015
  Purpose

This study will investigate the pharmacokinetics and safety of RoActemra/Actemra (tocilizumab) in patients less than 2 years old with active systemic juvenile idiopathic arthritis. Patients will receive RoActemra/Actemra infusions every 2 weeks. The anticipated time on study treatment is 12 weeks.


Condition Intervention Phase
Juvenile Idiopathic Arthritis, Rheumatoid Arthritis
Drug: Tocilizumab [RoActemra/Actemra]
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics (plasma concentration of tocilizumab) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety (incidence of adverse events) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: October 2012
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: Tocilizumab [RoActemra/Actemra]
Tocilizumab infusions every 2 weeks for 12 weeks

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, less than 24 months old at baseline
  • Diagnosis of systemic juvenile idiopathic arthritis (sJIA)
  • Duration of systemic juvenile idiopathic arthritis (sJIA) lasting at least 3 months since the onset of sJIA symptoms
  • Presence of active disease
  • Uncontrolled disease despite treatment with non-steroidal anti-inflammatory drugs and corticosteroids

Exclusion Criteria:

  • Any other auto-immune, rheumatic disease or overlap syndrome other than systemic juvenile idiopathic arthritis
  • Not fully recovered from recent surgery or less than 6 weeks since surgery at the time of screening visit, or planned surgery during study
  • Any significant concurrent medical or surgical condition which would jeopardize the patient's safety
  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: NCT01455701

Contacts
Contact: Reference Study ID Number: NP25737 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 21 Study Locations
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: NCT01455701     History of Changes
Other Study ID Numbers: NP25737
Study First Received: October 18, 2011
Last Updated: March 16, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on March 31, 2015