None listed
Conditions
Interventions
Group A1 Type of group
Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Group name:Group B2 Type of group
Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: • Adult participants, ≥ 18 years of age • Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria • Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline • Inadequate response to current DMARD therapy • Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline • Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline
Exclusion criteria
Exclusion criteria: • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization • Rheumatic autoimmune disease other than RA • Functional class IV (ACR classification) • Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16 • Prior history of or current inflammatory joint disease other than RA • Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline • Previous treatment with tocilizumab • Active current or history of recurrent infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patients Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patients Global Assessment of Disease Activity and Physicians Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein [CRP] or Erythrocyte Sedimentation Rate [ESR]). Measure:Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24 Timepoints:Baseline, 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patients Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patients Global Assessment of Disease Activity and Physicians Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable to do; and acute-phase reactant (either C-reactive protein or Erythrocyte Sedimentation Rate). Measure:Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24 Timepoints:Baseline, 24 weeks ; Outcome name:ACR70 response is defined as a ≥ 70% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the five additional ACR core set variables: Patients Assessment of Pain over the previous 24 hours using a Visual Analog Scale (VAS) where left end of the line 0=no pain to right end of the line 100=unbearable pain; Patients Global Assessment of Disease Activity and Physicians Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions in 8 areas (dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities) answered on a scale of 0=without difficulty to 3=unable | — |
Countries
Australia, Brazil, Bulgaria, Canada, Colombia, France, Guatemala, Hong Kong, Italy, Lithuania, Mexico, New Zealand, Philippines, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Thailand, United Kindgdom, United States
Contacts
Public ContactLuisa Garcia
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed