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

Roche

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tocilizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT01362062

ML22835

Details and patient eligibility

About

This observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe RA who have an inadequate response to current non-biologic DMARD and/or anti-TNF therapy. Data will be collected from each participant during tocilizumab therapy and on follow-up for a total of 12 months.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

110 participants in 1 patient group

RA Cohort

Description:

Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information will be observed for a total duration of 12 months.

Treatment:

Drug: Tocilizumab