Clinical Research Details

Descriptive Information
A prospective, non-interventional, multi-center observational study to evaluate the safety and efficacy of Tocilizumab in patients with moderate to severe active rheumatoid arthritis in routine practice

Imad Uthman
iuthman@aub.edu.lb

ML25533
Completed

Observational  

Phase 2  

No
Sponsors
  • Hoffman
  • LaRoche
Conditions and Keywords
Rheumatoid arthritis
Rhematoid arthritis, Tocilizumab efficay, Safety
Study Design
Treatment
Safety and/or Efficacy Study
Prospective
Open Label
Single Group
N/A: Not Applicable
Case-Only
Eligibility and IRB
Both
Min: 21
Max:
Yes
No



Primary care clinic


Non-probability sample


Adult (age  21 years) male or non-pregnant, non-nursing female, - patients with moderate to severe active rheumatoid arthritis (DAS28 ≥ 3.2) who have had an inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs),- patients receiving tocilizumab as a treatment for RA in accordance with the prescribing information,- Patients able and willing to give written informed consent within 6 weeks (42 days of initiating tocilizumab and comply with the requirements of the study protocol 


 Hypersensitivity to the active substance or to any of the constituent ,excipients,Combination with TNF-alfa inhibitors simultaneously or up to 1 month after treatment with anti-TNF antibodies,Previous treatment with tocilizumab

Patients who have received treatment with any investigation agent within 4 weeks (or 5 half-lives of investigation agent, whichever is longer) before starting treatment with tocilizumab.