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

CompletedN/A

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: tocilizumab

Countries: Belgium

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
* Concomitant treatment with NSAIDs and/or corticosteroids is allowed

Exclusion Criteria:

* Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
* Participants 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
* Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Locations (17)

Aalst, Belgium
Ath, Belgium
Brussels, Belgium
Brussels, Belgium
Genk, Belgium
Gilly (Charleroi), Belgium
Gosselies, Belgium
Haine-Saint-Paul, Belgium
Kortrijk, Belgium
Liège, Belgium
Liège, Belgium
Mons, Belgium
Ostend, Belgium
Ottignies, Belgium
Roeselare, Belgium
Turnhout, Belgium
Wilrijk, Belgium