Rheumatoid Arthritis
Conditions
Brief summary
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
Interventions
DRUGMethotrexate
7.5-20mg po weekly
DRUGtocilizumab [RoActemra/Actemra]
8mg/kg iv every 4 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients at least 18 years of age with active RA for at least 3 months; * patients of reproductive potential must be using reliable methods of contraception.
Exclusion criteria
* major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study; * treatment with methotrexate (MTX) within 6 months of entering study; * patients who have stopped previous MTX treatment due to toxicity or lack of response; * women who are pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with ACR 20 response | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with ACR 20 response | Week 8 |
| Percentage of patients with ACR 50 and ACR 70 responses | Week 24 |
| Mean change in parameters of ACR core set | Week 24 |
| AEs, laboratory parameters, vital signs. | Throughout study |
Countries
Argentina, Australia, Canada, China, Denmark, France, Israel, Italy, Lithuania, Mexico, Norway, Peru, Portugal, Serbia, Slovenia, South Africa, Spain, United States
Outcome results
None listed