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)

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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
We found this trial at
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Omaha, NE
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