Rheumatoid Arthritis Clinical Trial
Official title:
Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.
Status | Completed |
Enrollment | 197 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult patients, over 18 years of age - Moderate to severe rheumatoid arthritis - RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form Exclusion Criteria: - Patients with rheumatic autoimmune disease other than rheumatoid arthritis - Patients who are not willing to sign the informed consent form - Patients who participate in interventional trials during the period of this observational study |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of patients who remained under continued RoActemra/Actemra treatment | 6 months | No | |
Secondary | Reasons for withdrawal | 6 months | No | |
Secondary | Frequency of withdrawal | 6 months | No | |
Secondary | Frequency of dose modification | 6 months | No | |
Secondary | Reasons for dose modification | 6 months | No | |
Secondary | Safety: Incidence of adverse events | 6 months | No |
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