Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Rheumatoid Arthritis
Both
Rheumatoid Arthritis
Trial Information
Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.
Inclusion Criteria:
- adult patients, >/=18 years of age
- moderate to severe rheumatoid arthritis (DAS28 >3.2) of 6 months duration
- inadequate clinical response to non-biologic DMARDs or anti-TNF
- bodyweight
Exclusion Criteria:
- rheumatic autoimmune disease or inflammatory joint disease other than RA
- major surgery within 8 weeks prior to screening or planned major surgery within 6
months following screening
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and Tolerability: AEs, laboratory parameters
Outcome Time Frame:
AEs: event-driven assessments throughout study, laboratory assessments every 4 weeks for 24 weeks
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Qatar: Ministry of Health
Study ID:
ML22440
NCT ID:
NCT01089023
Start Date:
January 2010
Completion Date:
May 2012
Related Keywords:
- Rheumatoid Arthritis
- Arthritis
- Arthritis, Rheumatoid
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