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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01904292
First received: June 14, 2013
Last updated: June 2, 2017
Last verified: June 2017
  Purpose
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: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab [ Time Frame: Age <2 years: 0 hours(h) on Days(D) 0,84; on D5,14,42,70,85,88,98,182,266, 364. Weight <30kg, Age>=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266, 364 ]
  • Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Tocilizumab [ Time Frame: Age <2 years: 0h on D0,84; on D5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30 kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266,364 ]
  • Pharmacokinetics: Minimum Plasma Concentration (Cmin) of Tocilizumab [ Time Frame: Weight <30 kg: predose (0h) on Days 0 and 84. Weight >= 30 kg: predose (0h) on Days 0 and 91 ]

Secondary Outcome Measures:
  • Pharmacodynamics: Serum Interleukin-6 (IL6) Levels [ Time Frame: Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364 ]
  • Pharmacodynamics: Soluble IL-6 Receptor (sIL-6R) Levels [ Time Frame: Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364 ]
  • Pharmacodynamics: Serum C-Reactive Protein (CRP) Levels [ Time Frame: Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364 ]
  • Pharmacodynamics: Serum Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364 ]
  • Pharmacodynamics: Percentage of Participants with Anti-Tocilizumab Antibodies [ Time Frame: Age <2 years: Days 0, 84, 182, 266, 364. Weight <30 kg, Age >=2 years: Days 0, 84, 182, 266, 364. Weight >=30 kg: Days 0, 91, 182, 266, 364 ]
  • Safety: Percentage of Participants with At Least 1 Adverse Event [ Time Frame: 57 weeks ]

Estimated Enrollment: 48
Actual Study Start Date: August 15, 2013
Estimated Study Completion Date: November 30, 2017
Estimated Primary Completion Date: November 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tocilizumab
Participants will receive SC dose of tocilizumab 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

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of sJIA according to the International League of Associations for Rheumatology (ILAR) classification
  • 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, these must have been discontinued according to the timelines defined by protocol prior to the baseline visit
  • Participants currently receiving tocilizumab by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV tocilizumab and should have their first dose of SC tocilizumab administered on the date that their next IV tocilizumab 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 highly effective contraceptive methods

Exclusion Criteria:

  • Prior discontinuation of IV tocilizumab 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 tocilizumab
  • sJIA that is well controlled by any treatment agent other than tocilizumab (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 <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

  Show 42 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01904292     History of Changes
Other Study ID Numbers: WA28118
2012-003490-26 ( EudraCT Number )
Study First Received: June 14, 2013
Last Updated: June 2, 2017

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

ClinicalTrials.gov processed this record on June 23, 2017