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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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16 December 2017 |
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Main ID: |
NCT02307643 |
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Date of registration:
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18/11/2014 |
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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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Exploratory Study of MT-1303 in Systemic Lupus Erythematosus Patients
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Scientific title:
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An Exploratory Study of MT-1303 in Subjects With Systemic Lupus Erythematosus (a Multicenter, Open-label Study) |
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Date of first enrolment:
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February 2015 |
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Target sample size:
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17 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02307643 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Japan
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Contacts
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Name:
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Yoshiya Tanaka, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Occupational and Environmental Health |
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Name:
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Kazuoki Kondo, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mitsubishi Tanabe Pharma Corporation |
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Name:
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Tsutomu Takeuchi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Keio University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of SLE based on the American College of Rheumatology (ACR) criteria
- Presence of at least one of the following items: positive anti ds-DNA antibodies, low
complement levels, and so on.
- Stable doses of corticosteroids
Exclusion Criteria:
- Severe active lupus nephritis, neuropsychiatric SLE
Age minimum:
20 Years
Age maximum:
64 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: MT-1303 Low dose
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Drug: MT-1303 High dose
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Primary Outcome(s)
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Number of Subjects with Adverse Events
[Time Frame: up to 36 weeks]
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Secondary Outcome(s)
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Change from Baseline in anti-dsDNA and complement
[Time Frame: baseline and 24 weeks]
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Change from Baseline in Lymphocyte counts
[Time Frame: baseline and 24 weeks]
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Secondary ID(s)
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MT-1303-J03
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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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