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A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) (JIGSAW 117)

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ClinicalTrials.gov Identifier: NCT01904279
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : March 16, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Drug: Tocilizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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 Polyarticular Juvenile Idiopathic Arthritis
Study Start Date : July 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: TCZ SC 162 mg Q3W
Participants with body weight less than (<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks.
 Drug: Tocilizumab
Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Other Name: RoActemra/Actemra
Experimental: TCZ SC 162 mg Q2W
Participants with body weight greater than or equal to (>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks.
 Drug: Tocilizumab
Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Other Name: RoActemra/Actemra


Outcome Measures
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Primary Outcome Measures :
  1. Minimum Serum Concentration (Cmin) of TCZ at Steady State [ Time Frame: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) ]
    Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.

  2. Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment [ Time Frame: Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section) ]
    Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.

  3. Maximum Serum Concentration (Cmax) of TCZ at Steady State [ Time Frame: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section) ]
    Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old). Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.


Secondary Outcome Measures :
  1. Change From Baseline in Serum Interleukin-6 (IL-6) Levels [ Time Frame: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 ]
    IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset. It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.

  2. Change From Baseline in Soluble IL-6 Receptor Levels [ Time Frame: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52 ]
  3. Change From Baseline in C-Reactive Protein (CRP) Levels [ Time Frame: Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52 ]
  4. Change From Baseline in Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52 ]
    The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.

  5. Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential [ Time Frame: Baseline up to Week 52 ]

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

Inclusion Criteria:

  • Ages 1 year (12 years for participants in Russia) up to and including 17 years at screening
  • Diagnosis of pJIA according to International League of Associations for Rheumatology classification
  • Rheumatoid factor (RF)-positive pJIA
  • RF-negative pJIA
  • Extended oligoarticular JIA with a polyarticular course
  • History of inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate (MTX)
  • 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 SC TCZ administered on the date that their next IV TCZ infusion would be due. Participants participating in the study may be either naive to TCZ therapy or may be switching from IV to SC. The total number of participants switching from IV TCZ must account for no more than 50 percent (%) of the total participant number. To account for the baseline TCZ concentrations in these participants, information on the last 4 IV TCZ infusions prior to baseline will be collected
  • Concurrent treatment with disease-modifying antirheumatic drugs (DMARDs) (including MTX), nonsteroidal anti-inflammatory drugs (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)
  • Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
  • pJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score 71 [JADAS-71] less than or equal to (< / =) 3.8)
  • Participants who are wheelchair-bound or bedridden
  • Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets
  • 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 purified protein derivative (PPD) at screen, unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice
  • 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
  • Active uveitis at screening
  • Inadequate hematologic, renal or liver function
  • Prior stem cell transplant at any time
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904279


Locations
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United States, Connecticut
Hartford, Connecticut, United States, 06106
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60637
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Charlotte, North Carolina, United States, 28203
Durham, North Carolina, United States, 27710
United States, Ohio
Cincinnati, Ohio, United States, 45229-3039
United States, Oklahoma
Tulsa, Oklahoma, United States, 74135
United States, Utah
Salt Lake City, Utah, United States, 84109
United States, Washington
Seattle, Washington, United States, 98105
Argentina
Buenos Aires, Argentina, 1270
Australia, New South Wales
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Parkville, Victoria, Australia, 3052
Brazil
Rio de Janeiro, RJ, Brazil, 20551-030
Rio de Janeiro, RJ, Brazil, 21941-912
Sao Paulo, SP, Brazil, 05403-000
Sao Paulo, SP, Brazil, 22793-080
Canada, Alberta
Calgary, Alberta, Canada, T3B 6A8
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L1
Toronto, Ontario, Canada, M5G 1X8
France
Le Kremlin Bicêtre, France, 94275
Germany
Berlin, Germany, 13353
Freiburg, Germany, 79106
Sankt Augustin, Germany, 53757
Italy
Roma, Lazio, Italy, 00165
Genova, Liguria, Italy, 16147
Firenze, Toscana, Italy, 50139
Mexico
Monterrey, Mexico, 64460
Russian Federation
Moscow, Russian Federation, 115522
Moscow, Russian Federation, 119991
Spain
Esplugas de Llobregat, Barcelona, Spain, 08950
Madrid, Spain, 28034
Madrid, Spain, 28046
United Kingdom
Bristol, United Kingdom, BS2 8BJ
Liverpool, United Kingdom, L12 2AP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01904279    
Other Study ID Numbers: WA28117
2012-003486-18 ( EudraCT Number )
First Posted: July 22, 2013    Key Record Dates
Results First Posted: March 16, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases