A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients, \>/= 18 years of age
Moderate to severe active rheumatoid arthritis of \>/= 6 months duration
DAS28 \>/= 3.2 at screening and baseline
Inadequate response to biologic or non-biologic DMARDs
Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug
If continuing on a non-biologic DMARD, dose should be stable for at least 8 weeks
Oral corticosteroids must have been at stable dose for at least 25 out of 28 days prior to baseline
You may not be if
Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery
Rheumatic autoimmune disease other then RA
Functional class IV as defined by the American College of Rheumatology (ACR) classification
Prior history of or current inflammatory joint disease other than RA
Previous treatment with any cell-depleting therapies
Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline
Active infection or history of recurrent infection
Positive for HIV or hepatitis B or C
History of or current primary or secondary immunodeficiency
Clareo Health | A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.
