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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: |
NCT01643863 |
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Date of registration:
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16/07/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (MONACO)
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Scientific title:
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A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (TCZ) |
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Date of first enrolment:
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August 2012 |
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Target sample size:
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1 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01643863 |
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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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Portugal
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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 (1987) ACR criteria
- Patients in whom the treating physician has made the decision to commence
RoActemra/Actemra treatment in monotherapy, in case of methotrexate intolerance or
when continuous methotrexate treatment is inadequate (in accordance with the local
label), and who have received (or started) RoActemra/Actemra monotherapy treatment
within 8 weeks prior to the enrolment visit.
- Concomitant corticosteroids (oral or intra-articular) or non-steroidal
anti-inflammatory drugs (NSAIDs) are allowed
Exclusion Criteria:
- Patients in whom RoActemra/Actemra is contraindicated according to the approved
Summary of Product Characteristics
- Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment
visit
- Patients who have previously received RoActemra/Actemra in a clinical trial or for
compassionate use
- Concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine,
sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting
treatment with RoActemra/Actemra
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the
investigational agent, whichever is longer) before starting treatment with
RoActemra/Actemra
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid
arthritis
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 at 6 months
[Time Frame: approximately 20 months]
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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 20 months]
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Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
[Time Frame: approximately 20 months]
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Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs)
[Time Frame: approximately 20 months]
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Time to reduction/withdrawal of corticosteroids
[Time Frame: approximately 20 months]
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Physician Global Assessment of disease activity
[Time Frame: approximately 20 months]
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Rates of dose modifications/interruptions
[Time Frame: approximately 20 months]
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Patient reported outcomes: Health Assessment Questionnaires
[Time Frame: approximately 20 months]
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Safety: Incidence of adverse events\n
[Time Frame: approximately 20 months]
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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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