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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: |
NCT01610791 |
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Date of registration:
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31/05/2012 |
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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 RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)
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Scientific title:
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A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study) |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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121 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01610791 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Morocco
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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 (DAS28 > 3.2 at screening)
- Inadequate response to DMARDs
- Body weight < 150 kg
Exclusion Criteria:
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months of enrollment
- Rheumatic autoimmune disease other than RA
- American College of Rheumatology (ACR) functional class IV
- Prior history of or current inflammatory joint disease other than RA
- Previous treatment with any biologic drug that is used in the treatment of RA
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Pregnant or lactating women
- Active current or history of recurrent infection, active TB within the previous 3
years, HIV infection
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 [RoActemra/Actemra]
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Primary Outcome(s)
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Percentage of Participants With Adverse Events
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Secondary Outcome(s)
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Health Assessment Questionnaire (HAQ)
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Percentage of Participants Achieving Remission (DAS28 <2.6)
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Change From Baseline Low-Density Lipoprotein (LDL) and Total Cholesterol (TC) to Highest Values
[Time Frame: Baseline through Week 24]
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Physician's Global Assessment of Disease Activity (VAS)
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Percentage of Participants With Lipid Elevations by Study Visit
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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C-Reactive Protein (CRP)
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Disease Activity Score Based on 28-Joint Count (DAS28)
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Percentage of Participants by DAS28 Response Category
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Percentage of Participants With a Response Assessed Using American College of Rheumatology (ACR) Criteria
[Time Frame: Weeks 4, 8, 12, 16, 20, and 24]
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Percentage of Participants With a Clinically Meaningful Improvement in Disease Activity
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Time to Achieve Clinically Meaningful Reduction in DAS28
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Patient Assessment of of Pain (VAS)
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Patient Global Assessment of Disease Activity (VAS)
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Change From Baseline in Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) to Highest Value
[Time Frame: Baseline through Week 24]
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Erythrocyte Sedimentation Rate (ESR)
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 24]
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Percentage of Participants With All-Cause Discontinuation of Tocilizumab by Study Visit
[Time Frame: Weeks 4, 8, 12, 16, 20, and 24]
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Swollen and Tender Joint Counts
[Time Frame: Baseline, Weeks 4, 8, 12, 16, 20, and 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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