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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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19 October 2017 |
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Main ID: |
NCT01617005 |
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Date of registration:
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08/06/2012 |
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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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A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)
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Scientific title:
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Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD |
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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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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01617005 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Montenegro
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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:
- Moderate to severe active RA (European League Against Rheumatism [EULAR] criteria)
- Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
- Initiating treatment with tocilizumab according to SPC
Exclusion Criteria:
- Rheumatic autoimmune disease other than RA
- Prior history or current inflammatory joint disease other than RA
- Previous treatment with any biological drug used in the treatment of RA
- Previous treatment with tocilizumab
- Any contraindication to treatment with tocilizumab
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following enrollment
- Pregnant women or nursing (breastfeeding) mothers
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Tocilizumab
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Primary Outcome(s)
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Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
[Time Frame: Baseline up to Week 24]
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Secondary Outcome(s)
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Number of Participants Who Discontinued Treatment Due to Lack of Efficacy
[Time Frame: Baseline up to Week 24]
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Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria
[Time Frame: Baseline, Week 24]
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Time to Discontinuation Due to Lack of Efficacy
[Time Frame: Baseline up to Week 24]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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