None listed
Conditions
Interventions
Group 1 Type of group
Tocilizumab 10 mg/kg in patients weighing
Patients received placebo to tocilizumab intravenously every 4 weeks.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: • Documented evidence of juvenile idiopathic arthritis of polyarticular course (JIAP): Subgroup of polyarthritis of AU Positive rheumatoid factor or negative rheumatoid factor (JIA) for at least 6 months. Understanding oligoarticular JIA (AlJoe) of active polyarticular course for at least 6 months before admission to the study according to the ILAR Criteria [8] • The JIA of polyarticular course requires the presence of active disease with at least five joints with active arthritis (the joints that are inflamed or if they are not inflamed that have limited movement accompanied with pain on palpation or both) both in the selection as in the initial one (with at least three of the active joints with limited movement). • Age of 2 years up to and including 17 years of age at the time of enrollment • Comply with one of the following: that they have an inadequate response to MTX or cannot tolerate MTX • That they comply with one of the following: that they have not received MTX for at least 4 weeks before the initial visit. Have taken MTX for at least 12 weeks immediately before the initial visit and a stable dose> 10 to 1 week before the initial one, etanercept> 2 weeks before the initial one, rilonacept> 5 weeks before the initial one , infliximab or adalimumab> 8 weeks before the initial one, abatacept> 12 weeks before the initial one or canakinumab> 20 weeks before the initial one. • Written informed consent to participate in the study obtained from the parents or legal guardian with the corresponding consent of the patient, depending on the patient´s level of understanding.
Exclusion criteria
Exclusion criteria: • Confined to a wheelchair or a bed or have little or no personal care capability; • Any other rheumatic autoimmune disease or syndrome that overlaps connective tissue other than that of the JIA subgroups of polyarticular course; Polyarticular JIA Positive rheumatoid factor, Polyarticular JIA Negative rheumatoid factor, and extended oligoarticular JIA. Excluded diseases include, but are not limited to systemic juvenile idiopathic arthritis, Lyme disease, enthesitis-related arthritis; psoriatic arthritis, Reiter´s syndrome, systemic lupus erythematosus, infectious or reactive arthritis or parvovirus infections (See Appendix 1 for definitions) • They have not fully recovered from a recent surgery or less than 6 weeks since the surgery, at the time of the selection visit; o surgery planned during the initial 40 weeks of the study; • Lack of peripheral venous access or do not wish to undergo multiple venipunctions; • Pregnancy, lactation or intention to get pregnant during the study and up to 12 weeks after the last administration of the study medication; • Any concurrent medical or surgical condition that jeopardizes the patient´s safety or the ability to complete the study; • History of considerable infusion reactions or allergic to previous biological treatment; • History or primary or secondary immunodeficiency currently active. • History of alcoholism, drug addiction or abuse of chemical substances within 1 year of selection; • Evidence of serious uncontrolled concomitant diseases, including but not limited to, cardiovascular, pulmonary, nervous, renal, hepatic or endocrine system. • Any acute, subacute, chronic or recurrent bacterial, mycobacterial, viral or fungal systemic infection or opportunistic infection. • Active TB that required treatment within 2 years prior to the selection visit or currently active TB; • Positive PPD in the selection unless it is confirmed by radiography that it is negative for active tuberculosis in the selection and the patient has been treated with antituberculosis drugs for at least 4 weeks before receiving the study medication; • Any major episode of infection that requires hospitalization or treatment during selection or treatment with antibiotics i.v. completed within 4 weeks of the selection visit or oral antibiotics completed within 2 weeks of the selection visit • History of known recurrent or current active infectious disease, including, but not limited to chronic kidney infection, chronic lung infections (eg bronchiectasis), an open or drained or infected skin wound, sinusitis, recurrent urinary tract infection ( for example, recurrent pyelonephritis) • History of reactivation or new occurrence of a systemic infection such as herpes zoster or Epstein Barr virus within two months of the selection visit; • Surface Ag of Hepatitis B or Ab of Hepatitis C positive; • Chronic hepatitis • Major heart or lung disease [eg, congenital heart disease, valvular heart disease, constrictive pericarditis, myocarditis] (for example, asthma, cystitis, fibrosis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:JIA ACR30 flare is defined as a ≥ 30% worsening of 3 of 6 variables and no more than 1 of the remaining variables improving > 30%. The 6 variables are physician global assessment of disease activity (worsening of 20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (worsening of 20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Patients who withdrew or who took escape medication are classified as flared. The analysis used the Cochran-Mantel-Haenszel test with the stratification variables background use of methotrexate and oral corticosteroids applied at Week 16. Measure:Percent of Patients With a Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30 (ACR30) Flare in Part II of the Study (Weeks 16-40) Timepoints:Week 16 through Week 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:A JIA ACR30/50/70/90 response is defined as a ≥ 30/50/70/90% response on 3 of 6 variables and no more than 1 of the remaining variables worsening > 30%. The 6 variables are physician global assessment of disease activity (20 units minimum on a 0-100 visual analog scale [VAS]), parent/patient global assessment of overall well-being (20 VAS units minimum), number of joints (minimum of 2 worse) with active arthritis (swelling, or pain and limitation of motion), number of joints (minimum of 2 worse) with limitation of movement, erythrocyte sedimentation rate, and functional ability assessed using the disability index of the Childhood Health Assessment Questionnaire (CHAQ, 30 questions, 8 domains, 0[best]-3[worst]). Measure:Percent of Patients Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology 30, 50, 70, and 90 (ACR30/50/70/90) Responses in Part I of the Study (Baseline to Week 16) Timepoints:Baseline to Week 16 ; Outcome name:The patients treating physician provides a rating of the patients arthritis disease activity on a 0 to 100 mm horizontal scale. The extreme left end of the line represents arthritis inactive (ie, symptom-free and no arthritis symptoms) and the extreme right end represents arthritis very active. A higher score indicates more disease activity. A negative change score indicates improvement. Measure:Percent Change From Baseline in the Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) Component Score Physician Global Assessment of Disease Activity at the End of Part I of the Study (Week 16) Timepoints:Baseline to Week 16 ; Outcome name:The patient or parent/guardian, as appropriate, provides a rating of the patients well-being on a 0 to 100 mm horizontal scale. The extreme left end of the line represents very well (ie, symptom-free and no arthritis disease activity) and the extreme right end represents very poor (ie, maximum arthritis disease activit | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Netherlands, Poland, Russian Federation, Spain, United Kindgdom, United States
Contacts
Public ContactLUISA GARCIA
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed