A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: June 14, 2013
Last updated: November 2, 2015
Last verified: November 2015
This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>/=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.

Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: Tocilizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Minimum Plasma Concentration (Cmin) of Tocilizumab [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Tocilizumab [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Percentage of Participants with Atleast 1 Adverse Event [ Time Frame: 57 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Serum Interleukin-6 (IL6) Levels [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Soluble IL-6 Receptor (sIL-6R) Levels [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Serum C-Reactive Protein (CRP) Levels [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Serum Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Percentage of Participants with Anti-Tocilizumab Antibodies [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tocilizumab (TCZ)
Participants will receive SC dose of TCZ based on body weight; participants with <30 kg will receive 162 milligrams (mg) of tocilizumab Q2W and those participants >= 30 kg will receive 162 mg of tocilizumab QW, for 52 weeks.
Drug: Tocilizumab
Subcutaneous 162 mg dose QW or Q2W for 52 weeks
Other Name: RoActemra/Actemra


Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ages 1 year up to and including 17 years at screening
  • Diagnosis of sJIA according to the International League of Associations for Rheumatology (ILAR) classification (Petty et al. 2004)
  • History of inadequate clinical response (in the opinion of the treating physician) to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids
  • If a participant has received previous treatment with any biologic agents other than tocilizumab (TCZ), these must have been discontinued according to the timelines defined by protocol prior to the baseline visit
  • Participants currently receiving TCZ by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV TCZ and should have their first dose of subcutaneous (SC) TCZ administered on the date that their next IV TCZ infusion would be due
  • Concurrent treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), NSAIDs, and oral corticosteroids are permitted at the discretion of the investigator
  • Participants of reproductive potential must be willing to use reliable contraceptive methods

Exclusion Criteria:

  • Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity)
  • Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
  • sJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score of 71 Joints (JADAS-71) less than or equal to (</=) 3.8 with no fever
  • Participants who are wheelchair-bound or bedridden
  • Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA
  • Lack of recovery from recent surgery or an interval of greater than (<) 6 weeks since surgery at the time of the screening visit
  • Females who are pregnant, lactating, or intending to become pregnant during study conduct
  • Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the study
  • Known Human Immunodeficiency Virus (HIV) infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
  • History of alcohol, drug, or chemical abuse within 6 months of screening
  • Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit
  • History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit
  • Positive TB test at screening unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug
  • History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months of the screening visit
  • Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis
  • History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
  • History of or current cancer or lymphoma
  • Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin
  • Macrophage activation syndrome (MAS) within 3 months of the screening visit
  • Inadequate hematologic, renal or liver 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: NCT01904292

Contact: Reference Study ID Number: WA28118 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 41 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01904292     History of Changes
Other Study ID Numbers: WA28118, 2012-003490-26
Study First Received: June 14, 2013
Last Updated: November 2, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2015