A Study of Subcutaneously Administered RoActemra/Actemra (Tocilizumab) in Patients With Systemic Juvenile Idiopathic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01904292
First received: June 14, 2013
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in patients with systemic juvenile idiopathic arthritis. Patients will receive RoActemra/Actemra subcutaneously weekly or every 10 days for 52 weeks.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: tocilizumab [RoActemra/Actemra]
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
Official Title: A Phase Ib, Open Label, Multicenter Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration in Patients With Systemic Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Serum concentrations (Cmin/Cmax) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamics: Serum interleukin-6 (IL6)/soluble IL-6 receptor (sIL-6R) levels [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: C-reactive protein (CRP) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Erythrocyte sedimentation rate (ESR) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Incidence of anti-TCZ antibodies [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 57 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: August 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra/Actemra Drug: tocilizumab [RoActemra/Actemra]
Subcutaneous doses weekly or every 10 days for 52 weeks

  Eligibility

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

Inclusion Criteria:

  • Ages 1 year up to and including 17 years at screening
  • Diagnosis of sJIA according to the ILAR classification (Petty et al. 2004)
  • History of inadequate clinical response (in the opinion of the treating physician) to NSAIDs and corticosteroids
  • If a patient has received previous treatment with any biologic agents other than TCZ (tocilizumab), these must have been discontinued according to the timelines defined by protocol prior to the baseline visit
  • Patients currently receiving TCZ by the 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 SC TCZ administered on the date that their next IV TCZ infusion would be due
  • Concurrent treatment with DMARDs (including MTX), NSAIDs, and oral corticosteroids are permitted at the discretion of the investigator
  • Females of childbearing potential and non-sterile males with female partner of childbearing potential must agree to use effective contraception as defined by protocol

Exclusion Criteria:

  • Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity)
  • Patients 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 [JADAS]-71 </= 3.8 with no fever)
  • Patients 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 < 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 patient's safety or ability to complete the study
  • Known 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
  • History of macrophage activation syndrome (MAS) < 3 months' duration prior to 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

Contacts
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 39 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: NCT01904292     History of Changes
Other Study ID Numbers: WA28118
Study First Received: June 14, 2013
Last Updated: July 14, 2014
Health Authority: United States: Food and Drug Administration

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 24, 2014