An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | April 2012 |
| End Date: | June 2014 |
| Contact: | Please reference Study ID Number: ML28247 www.roche.com/about_roche/roche_worldwide.htm |
| Email: | genentechclinicaltrials@druginfo.com |
| Phone: | 888-662-6728 (U.S. Only) |
HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD
This multicenter observational study will evaluate the use of RoActemra/Actemra
(tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis
unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will
be followed for 6 months.
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- Patients who for any reason do not take methotrexate and for whom the treating
physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients
who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment
visit may be included
- Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or
corticosteroids (orally or intra-articularly) is allowed
Exclusion Criteria:
- Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment
visit
- Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine,
sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of
investigational agent, whichever is longer) before starting RoActemra/Actemra
treatment
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid
arthritis
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