FRESH-PEF74130-en
PharmacoEpidemiological study of the imPact of RoActemra® treatment on fatigue in rheumatoid arthritis patientS in a real life setting
PEPS
| Name | Country code |
|---|---|
| France | fr |
['Clinical 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: - Male or woman aged over 18 years. - Patients presenting with moderate to severe rheumatoid arthritis and for which treatment with RoActemra(R) was planned by the investigator; - Patients willing and able to complete, during consultations and at home, the study questionnaires aimed at evaluating the impact of their disease and treatment; - Patients who received complete written and oral information about the study, and who gave their consent for future automated processing of the data generated during the study. ","clusion_E":"Patient with known hypersensitivity to RoActemra®, or to any constituent of the study medication; - Patient presenting with an active concomitant infection; - Patient currently participating in a clinical trial aimed at evaluating another treatment in rheumatoid arthritis."}
| 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 |
|---|---|
| 2010-01-01 | 2011-01-01 |
| 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 |