FRESH-PEF74129-en
Description in real life of glucocorticoid-sparing in patients treated with Roactemra® for moderate to severe rheumatoid arthritis
SPARE-1
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Biological data']
Individuals
| Topic | Vocabulary |
|---|---|
| Rheumatology | health theme |
| Inflammatory arthropathies | cim-11 |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"Inclusion criteria: - Patients aged 18 years and older; - Patients with moderate to severe rheumatoid arthritis; - Patients for whom the rheumatologist decided to initiate treatment with RoActemra®; - Patients taking oral glucocorticoids >5 mg/day of prednisone or equivalent for at least 3 months; - Patients having received oral and written information about the study and having raised no objections to the collection and computer processing of his/her personal data. ","clusion_E":"patients participating in a clinical trial on rheumatoid arthritis at time of inclusion could not participate to the study."}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
| Agency name |
|---|
| Other |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2011-01-01 | 2013-01-01 |
| Standard |
|---|
| ['CDISC'] |
['GCP/GVP']
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
| Name | |
|---|---|
| ;Medical data center | data_sharing.france@roche.com |