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Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis

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ClinicalTrials.gov Identifier: NCT02165345
Recruitment Status : Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE June 13, 2014
First Posted Date  ICMJE June 17, 2014
Last Update Posted Date February 19, 2019
Actual Study Start Date  ICMJE July 16, 2014
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
  • Juvenile Arthritis Disease Activity Score (JADAS-71) [ Time Frame: Baseline up to 3 years ]
  • Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest [ Time Frame: Baseline up to 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 16, 2014)
  • Incidence of serious adverse events [ Time Frame: Up to 3 years ]
  • Incidence of adverse events of special interest [ Time Frame: Up to 3 years ]
  • Incidence of clinical laboratory abnormalities [ Time Frame: Up to 3 years ]
  • Change in Juvenile Arthritis Disease Activity Score (JADAS-71) [ Time Frame: Up to 3 years ]
  • Change in Childhood Health Assessment Questionnaire (CHAQ) Score [ Time Frame: Up to 3 years ]
  • Inactive disease/clinical remission [ Time Frame: Up to 3 years ]
  • Incidence of adverse events [ Time Frame: Up to 3 years ]
Change History Complete list of historical versions of study NCT02165345 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Childhood Health Assessment Questionnaire (CHAQ) Score [ Time Frame: Baseline up to 3 years ]
  • Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission [ Time Frame: Baseline up to 3 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis
Official Title  ICMJE Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
Brief Summary This open-label extension of the JIGSAW studies (WA28117 [NCT01904279] and WA28118 [NCT01904292]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis subtype and body weight. Participants will receive the treatment until commercial availability of the drug or for a maximum of 5 years, whichever is earlier.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Juvenile Idiopathic Arthritis
Intervention  ICMJE Drug: Tocilizumab
162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (>=) 30 kg: every 2 weeks; sJIA participants <30 kg: every 2 weeks; sJIA participants >/= 30 kg: once weekly
Other Name: RoActemra, Actemra
Study Arms  ICMJE Experimental: Tocilizumab
Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier.
Intervention: Drug: Tocilizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 10, 2018)
82
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2014)
96
Estimated Study Completion Date  ICMJE September 15, 2020
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Completion of either of the JIGSAW studies, study WA28117 (for participants with pJIA) or study WA28118 (for participants with sJIA)
  • Adequate disease control with the use of SC tocilizumab(TCZ)(comparable to the use of IV TCZ, if received prior to enrollment in the JIGSAW study), per clinical judgment of the investigator
  • For participants of reproductive potential: agreement to remain abstinent or use of effective contraception as defined by the study protocol

Exclusion Criteria:

  • Prior discontinuation of SC tocilizumab because of inadequate clinical response during participation in a JIGSAW study
  • Poorly controlled disease (in opinion of treating physician) despite treatment with SC tocilizumab in the JIGSAW study
  • Prior discontinuation of intravenous tocilizumab because of inadequate clinical response or safety events (including hypersensitivity)
  • Therapy with biologic agents (except tocilizumab) in the period between completion of the JIGSAW study and screening for the current study
  • Concurrent treatment with disease-modifying anti-rheumatic drugs (DMARDs) (including methotrexate), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids is permitted at the discretion of the investigator
  • Use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide
  • Any significant concurrent medical or surgical conditions or findings that would jeopardize the participant's safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection
  • History of alcohol, drug, or chemical abuse within 6 months prior to screening
  • History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening
  • Known human immunodeficiency virus infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
  • Clinical signs or symptoms of acute or chronic viral hepatitis or chronic autoimmune hepatitis arising since enrollment in the JIGSAW study
  • 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 (HbA1c), defined with the use of age-specific standards
  • Any abnormal laboratory values, an elevation of hepatic transaminases ([aspartate aminotransferase [AST] or alanine aminotransferase [ALT]), lowering of neutrophil count, or thrombocytopenia attributed to tocilizumab use by investigator at screening, the participant may be enrolled; however, the initial tocilizumab dose may be delayed to adhere to the protocol risk mitigation strategy or per the investigator's clinical judgment
  • Prior stem cell transplant at any time
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   Russian Federation,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02165345
Other Study ID Numbers  ICMJE WA29231
2013-005212-98 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP