JRCT ID: jRCT1030210647
Registered date:06/03/2022
Impact of quality of life to overall productivity impairment and activity impairment of patients with systemic lupus erythematosus
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Systemic lupus erythematosus |
Date of first enrollment | 25/03/2022 |
Target sample size | 207 |
Countries of recruitment | |
Study type | Observational |
Intervention(s) | - |
Outcome(s)
Primary Outcome | Assess the residual burden remaining after meet LLDAS. |
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Secondary Outcome | Relationship between Activity Impairment and PROs in 2 groups (non LLDAS/LLDAS). |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1. Patients with informed consent 2. Patients with Age >= 18 years old 3. Patients diagnosed with SLE >= 16 years old 4. Patients diagnosed as systemic lupus erythematosus according to the revised 1997 American College of Rheumatology (ACR) or SLICC criteria. |
Exclude criteria | 1. Patients with a diagnosis of SLE within 12 months. 2. Patients who are judged to need hospitalization when unscheduled visit. 3. Patient who, in the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason. |
Related Information
Primary Sponsor | Tanaka Michio |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
Contact
Public contact | |
Name | Mitsuru Hoshino |
Address | Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka City, Osaka Osaka Japan 530-0011 |
Telephone | +81-6-4802-3600 |
mitsuru.hoshino@astrazeneca.com | |
Affiliation | AstraZeneca K.K. |
Scientific contact | |
Name | Michio Tanaka |
Address | Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka City, Osaka Osaka Japan 530-0011 |
Telephone | +81-6-4802-3600 |
Michio.Tanaka@astrazeneca.com | |
Affiliation | AstraZeneca K.K. |