Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Trade Name: RoActemra®
Product Code: Ro 487-7533/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Current Sponsor code: R04877533
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult (= 18 years) patients with moderate to severe active RA of = 6 months duration DAS28 = 3.2 at screening and baseline Patients must have discontinued biologic DMARDs prior to receiving tocilizumab (patient must have discontinued etanercept for = 2 weeks, infliximab or adalimumab for = 8 weeks, anakinra for = 1 week, rituximab > 24 weeks [or B-cell count has returned to levels prior to treatment and patient meets requirement for active disease]) If continuing non-biologic DMARDs, the dose must be stable for 8 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery History of or current inflammatory joint disease or rheumatic autoimmune disease other than RA Active current infection or history of recurrent bacterial, viral, fungal, or mycobacterial infection Pregnant women or nursing (breast feeding) mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the mechanisms of TCZ effects on neutrophil function and survival.;Secondary Objective: To assure safety (adverse events, laboratory abnormalities, using risk minimization strategies for AEs of Special Interest, section 7) and benefit:risk of TCZ 8 mg/kg as monotherapy or in combination with allowed non-biologic DMARDs, according to SPC and evaluation of benefit by improvements in DAS28.;Primary end point(s): Neutrophil survival and function results reported descriptively: Apoptosis: - Neutrophil morphology by light microscopy (change in proportion of cells apoptotic) utilizing a combination of staining and dynamic confocal microscopy - Change in cell surface molecules: activation marker CD16, and membrane phosphatidyl serine Neutrophil function: - by ex vivo flow cytometry measurement of surface molecule expression, including Fc?-receptor, and - Phagocytosis markers ex vivo (respiratory burst, labeled bacteria) | — |
Countries
United Kingdom
Outcome results
None listed