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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 : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
Actual Study Start Date : July 16, 2014
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2020


Arm Intervention/treatment
Experimental: Tocilizumab
Participants will receive tocilizumab until the commercial availability of the drug or up to 5 years, whichever is earlier.
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




Primary Outcome Measures :
  1. Juvenile Arthritis Disease Activity Score (JADAS-71) [ Time Frame: Baseline up to 3 years ]
  2. Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest [ Time Frame: Baseline up to 5 years ]

Secondary Outcome Measures :
  1. Childhood Health Assessment Questionnaire (CHAQ) Score [ Time Frame: Baseline up to 3 years ]
  2. Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission [ Time Frame: Baseline up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02165345


  Show 31 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02165345     History of Changes
Other Study ID Numbers: WA29231
2013-005212-98 ( EudraCT Number )
First Posted: June 17, 2014    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018

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