A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)

A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01893255

Enrollment

Registered

2013-07-08

Start date

2012-09-30

Completion date

2014-06-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/= 18 years of age * Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria * Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label; this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit * Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy * Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy * Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed

Exclusion criteria

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit * Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use * Patients receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) * Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra * Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Design outcomes

Primary

Measure	Time frame
Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation	Month 6

Secondary

Measure	Time frame
Rates of dose modifications/interruptions	approximately 6 months
Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR	approximately 6 months
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment	approximately 6 months
Safety: Incidence of adverse events	approximately 6 months
Patient reported outcomes (Patient Global Assessment of disease activity, HAQ-DI, VAS-Fatigue, severity of pain and morning stiffness)	approximately 6 months
Physician's Global Assessment of Disease Activity	approximately 6 months

Outcome results