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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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13 May 2013 |
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Main ID: |
NCT01251120 |
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Date of registration:
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30/11/2010 |
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Primary sponsor: |
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Public title:
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A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis
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Scientific title:
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A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis |
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Date of first enrolment:
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November 2011 |
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Target sample size:
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2 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01251120 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Finland
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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, over the age of 18 years
- Diagnosis of moderate-to-severe active early rheumatoid arthritis (RA) of less than 2
years duration
- DAS28 >3.2
- Swollen joint count (SJC) >/=6 (66 joint count), and tender joint count (TJC) >/=6
(68 joint count)
- Patients who have received DMARDs (including methotrexate) for 3-7 months
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months after baseline
- Rheumatic autoimmune disease other than rheumatoid arthritis (secondary Sjögrens
syndrome or nodulosis with RA is permitted)
- Functional class III or IV as defined by ACR Classification of Functional Status in
Rheumatoid Arthritis
- Prior history of or current inflammatory joint 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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Intervention(s)
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Drug: DMARD
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Drug: tocilizumab [RoActemra/Actemra]
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Primary Outcome(s)
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Proportion of patients achieving disease remission (DAS28 <2.6)
[Time Frame: 12 months]
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Secondary Outcome(s)
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Proportion of patients achieving clinical disease activity index (CDAI) remission
[Time Frame: 12 months]
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Proportion of patients achieving disease remission (DAS28<2.6)
[Time Frame: 6 months]
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Proportion of patients achieving responses according to American College of Rheumatology (ACR) criteria
[Time Frame: 12 months]
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Quality of life questionnaire
[Time Frame: 12 months]
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Safety (incidence of adverse events)
[Time Frame: 12 months]
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Work Productivity (absence from work)
[Time Frame: 12 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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