moderate to severe active rheumatoid arthritis
Conditions
Interventions
Trade Name: RoActemra®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: RoActemra
Concentration unit: mg/ml m
Sponsors
Roche Slovensko s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients able and willing to sign Inform Consent Form 2.Patients with moderate to severe active rheumatoid arthritis (according to ACR diagnostic criteria) 3.Inadequate response , or intolerance to previous therapy with one or more traditional DMARDs 4.DAS > 3,6 5.Age =18 6.Pneumology examination including chest x-ray, Quantiferon test and approval of pneumologist to initiation of biologic treatment 7.Approval of Committee for treatment of resistant form RA in National Institute of Rheumatic Diseases 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: 8. Known hypersensitivity to the drug substance or to any of the drug excipients. 9. UNL 17.Thrombocytes < 100 000/ mm3, Leucocytes < 3000 mm/3, absolute neutrophil count< 2000 mm/3, 18.Uncontrolled hyperlipoproteinemia 19.Demyelinating disorders 20.Serious cardiovascular disorders 21.Female in fertile age with partners who do not accept usage of contraceptives 22.Concomitant antiTNF drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment (adherent patients and all-case discontinuation or premature withdrawal of treatment);Secondary Objective: Safety and tolerability (Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected tocilizumab related AEs);Primary end point(s): •Percentage of patients fully adherent by the end of the treatment •Number and percentage of patients with all-cause treatment discontinuation •Number and percentage of patients with all-cause premature withdrawal | — |
Countries
Slovakia
Outcome results
None listed