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 :
Completed
First Posted : June 17, 2014
Last Update Posted : February 23, 2022
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Condition or disease | Intervention/treatment | Phase |
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Juvenile Idiopathic Arthritis | Drug: Tocilizumab | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | N/A |
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 |
Actual Primary Completion Date : | November 24, 2021 |
Actual Study Completion Date : | November 24, 2021 |

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

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

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

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT02165345 |
Other Study ID Numbers: |
WA29231 2013-005212-98 ( EudraCT Number ) |
First Posted: | June 17, 2014 Key Record Dates |
Last Update Posted: | February 23, 2022 |
Last Verified: | February 2022 |
Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |