Arthritis, Rheumatoid Clinical Trial
— Stress-PROfficial title:
Impact of Life Events and Psychological Stress in Rheumatoid Arthritis Set-up : Case-control Study Within a Multifactorial and Integrative Psychological Model
NCT number | NCT03550833 |
Other study ID # | CHUBX 2018/01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2018 |
Est. completion date | July 4, 2019 |
Verified date | September 2019 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Rheumatoid Arthritis (RA) is an inflammatory rheumatic disease that can lead to structural damage and handicap. The RA physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the RA mechanism, and improves the diagnosis and the treatment of the disease.
Status | Completed |
Enrollment | 152 |
Est. completion date | July 4, 2019 |
Est. primary completion date | July 4, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Patients RA : Inclusion Criteria: - patients aged over 18 years old - patients affected by RA according to ACR/EULAR 2010 criteria, with a disease duration less than 2 years. - Speaking and understanding French language - Being informed about the study and having given his oral consent Exclusion Criteria: - Pregnant or breastfeeding women - Patient who refuse to participate. Control : Inclusion Criteria: - patients aged over 18 years old - patients with a visceral surgery for less than 2 years (appendectomy, cholecystectomy, bowel obstruction, hernia, eventration…) - Speaking and understanding French language - Being informed about the study and having given his oral consent Exclusion Criteria: - Pregnant or breastfeeding women - Patient who refuse to participate |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux - service de rhumatologie | Bordeaux | |
France | CH de Dax - service de rhumatologie | Dax | |
France | Hôpital Suburbain du Bouscat | Le Bouscat | |
France | CH de Libourne - service de rhumatologie | Libourne | |
France | CH de Pau - service de rhumatologie | Pau |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Life events calculated over the year preceding the onset of PR symptoms | Social Readjustment Rating Scale (SRRS) | At inclusion (day 0) | |
Secondary | Perceived stress | Perceived Stress Scale (PSS) | At inclusion (day 0) | |
Secondary | Perceived control | Multidimensional Health Locus of Control Scale (MHLCS) | At inclusion (day 0) | |
Secondary | Perceived social support | Social Support Questionnaire (SSQ) | At inclusion (day 0) | |
Secondary | State Anxiety | State-Trait Anxiety Inventory (STAI-Y-A) | At inclusion (day 0) | |
Secondary | Coping | Ways of Coping Checklist Scale (WCC) | At inclusion (day 0) | |
Secondary | Cytokine levels in RA patients sera | 12 months from baseline | ||
Secondary | Correlation between cytokine levels and RA activity | 12 months from baseline | ||
Secondary | Correlation between cytokine levels and stress for RA patients | 12 months from baseline | ||
Secondary | Identification of neuropathic pain for RA patients evalued by douleur-neuropathique 10 items questionnaire | douleur-neuropathique 10 items questionnaire providing a score between 0 and 10, with a positive threshold value beyond 4/10. | 12 months from baseline | |
Secondary | Characterization of neuropathic pain for RA patients evalued by Neuropathic Pain Symptom Inventory questionnaire | Neuropathic Pain Symptom Inventory questionnaire with 12 items to complete, providing for each item the presence (or the absence) of several pain symptoms | 12 months from baseline |
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