Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - adult patients, >/=18 years of age - rheumatoid arthritis of >6 months duration - intolerant of methotrexate or continued treatment with methotrexate is considered inappropriate - all DMARDs are to be withdrawn prior to receiving study drug - weight =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - major surgery (including joint surgery) within 12 weeks prior to baseline or planned major surgery within 6 months after baseline - history of or current inflammatory joint disease other than RA - treatment with a biologic agent at any time prior to baseline - intraarticular or parenteral corticosteroids </=4 weeks prior to baseline - active current infection or history of recurrent bacterial, viral, fungal or mycobaterial infection - history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or to latex (due to the needle cover of Humira being made of latex)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the change in DAS28 from baseline to Week 24 for patients on tocilizumab (TCZ) vs adalimumab (ADA).; Secondary Objective: - To assess efficacy parameters using ACR criteria, EULAR criteria and patient reported health assessments - To compare adverse events - To compare laboratory changes ;Primary end point(s): The primary endpoint is the change in DAS28 at Week 24. | — |
Countries
Belgium, Czech Republic, Finland, Germany, Greece, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed