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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00996203 |
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Date of registration:
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15/10/2009 |
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Primary sponsor: |
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Public title:
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A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
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Scientific title:
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Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ) |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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201 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00996203 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Russian Federation
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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 active rheumatoid arthritis of >/=6 months duration
- inadequate clinical response to current non-biologic DMARDs
- current DMARDs must be at stable dose for 8 weeks prior to study entry
- oral corticosteroids ( stable dose for >/=4 weeks prior to screening
Exclusion Criteria:
- rheumatic autoimmune disease other than RA
- history of or current inflammatory joint disease other than RA
- previous treatment with any biologic DMARD
- functional class IV as defined by the ACR classification
- intra-articular or parenteral corticosteroids within 6 weeks prior to screening
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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Intervention(s)
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Drug: DMARDs (disease-modifying antirheumatic drugs)
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Drug: tocilizumab [RoActemra/Actemra]
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Primary Outcome(s)
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Quality of life: HAQ and EQ-5D scores
[Time Frame: every 4 weeks up to week 24]
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Secondary Outcome(s)
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Disease activity (DAS28), ACR and EULAR responses, CRP, ESR
[Time Frame: every 4 weeks up to week 24]
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Safety and tolerability: AEs. laboratory parameters
[Time Frame: throughout study, laboratory assessments every 4 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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