None listed
Conditions
Interventions
Group 1 Type of group
Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
Group name:Goup 4 Type of group
Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
No minimum to 80 Years
Inclusion criteria
Inclusion criteria: • Adult patients ≥ 18 years of age. • Rheumatoid arthritis of ≤ 2 years duration. • Disease Activity Score 28 (DAS28) > 3.2. • Swollen joint count (SJC) ≥ 4 of 66 joints, tender joint count (TJC) ≥ 6 of 68 joints. • Rheumatoid factor (RF) and/or anti−cyclic citrullinated peptide (anti-CCP) positive (if RF and anti-CCP negative > 1 erosion required at screening). • Erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ 10 mg/L at screening.
Exclusion criteria
Exclusion criteria: • Previous treatment with tocilizumab. • Previous treatment with methotrexate or biologic agent. • Rheumatic autoimmune disease other than rheumatoid arthritis (RA). • History of or current inflammatory joint disease other than RA. • Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in RA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A participant has a DAS28 remission response if their DAS28 < 2.6. The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patients global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Measure:Percentage of Participants With a Disease Activity Score 28 (DAS28) Remission Response at Week 24 Timepoints:Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Improvement must be seen in tender (68) and swollen (66) joint counts. Joints were assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation. Improvement must also be seen in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, the extreme left end of the line no disease activity [symptom-free and no arthritis symptoms] and the extreme right end maximum disease activity; patient assessment of pain in previous the 24 hours on a VAS (extreme left end of the line no pain and the extreme right end unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and C-reactive protein (CRP), or erythrocyte sedimentation rate if CRP was missing. Measure:Percentage of Patients With an Improvement ≥ 20%, 50%, or 70% in American College of Rheumatology (ACR) Score (ACR20/50/70) From Baseline to Weeks 24 and 52 Timepoints:Weeks 24 and 52 ; Outcome name:The mTSS is a measure of joint damage and includes measures of joint erosion (JE) and joint space narrowing (JSN). The JE score, using the van der Heijde modification, measures erosion severity in 32 hand joints and 12 foot joints. Each hand joint is scored from 0 to 5 and each foot joint is scored from 0 to 10; the total score ranges from 0 to 280. Each joint is scored according to the surface area involved. A score of 10 indicates extensive loss of bone from more than one-half of the articulating bone; a score of 0 indicates no erosion. The JSN score measures the severity of JSN in 30 hand joints (15 per hand) and 12 foot joints (6 per foot). Each joint, including subluxation, is scored from 0 to 4; the total score ranges from 0 to 168. A higher score indicates more joint space na | — |
Countries
Denmark, Finland, France, Germany, Greece, Hungaria, Ireland, Italy, Peru, Portugal, Spain, Sweden, United Kindgdom
Contacts
Public ContactPatricia Matos
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed