Clareo Health | Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy
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
Moderate to severe active RA with an inadequate response to existing therapies (DMARDs and/or anti-TNFs)
Considered eligible for tocilizumab therapy by the treating physician as per routine clinical practice
You may not be if
Pregnant or breastfeeding females
Immunization with live/attenuated vaccine within 4 weeks prior to baseline
Participants with clinically significant raised liver enzyme, abnormal lipid profile, platelet count, hemoglobin, white blood cell and neutrophil count
History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
Participants with active tuberculosis (TB). Participants with latent TB should be treated with standard anti-mycobacterial therapy before initiating tocilizumab and have a negative chest x ray for active TB at enrolment
History of diverticulitis, chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispose to perforations then the benefit risk ratio should be considered by treating physician
Know active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection
History of or currently active primary or secondary immunodeficiency or known human immunodeficiency virus (HIV) positive status
Any other condition which puts the participant to undue risk for tocilizumab therapy as per local prescribing information or Investigator's judgement
