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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 November 2016 |
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Main ID: |
NCT01615419 |
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Date of registration:
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06/06/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Observational Study of RoActemra/Actemra (Tocilizumab) in Rheumatoid Arthritis Patients
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Scientific title:
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A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab |
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Date of first enrolment:
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May 2012 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01615419 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis , according to the revised ACR criteria
- Patients initiated on RoActemra/Actemra treatment (in accordance with the local
label) on their treating physicians decision
Exclusion Criteria:
- RoActemra/Actemra treatment more than 8 weeks prior to enrolment visit
- Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of
investigational agent, whichever is longer) before starting treatment with
RoActemra/Actemra
- History of autoimmune disease or of any joint inflammatory disease other than RA
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Primary Outcome(s)
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Proportion of patients on RoActemra/Actemra treatment at 6 months
[Time Frame: approximately 2 years]
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Secondary Outcome(s)
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Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
[Time Frame: approximately 2 years]
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Efficacy: Monotherapy versus combination therapy
[Time Frame: approximately 2 years]
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Rates of dose modifications/interruptions
[Time Frame: approximately 2 years]
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Clinical/demographic patient characteristics at initiation of treatment
[Time Frame: approximately 2 years]
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Use of disease-modifying anti-rheumatic drugs (DMARDs)
[Time Frame: approximately 2 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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