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The purpose of the present study is to assess the measurement properties of a tolerability questionnaire. The results obtained in patients with Rheumatoid Arthritis (RA) being treated will be robust and will assess the patient's tolerability to the treatment. Patients with greater tolerability will be more satisfied with their treatment.
Clinicians do not have any standardized questionnaire to assess the tolerability from the patient's perspective. The tolerability assessment of the different pharmacological strategies for Rheumatoid Arthritis, from the patient's perspective, would provide additional information, improve doctor-patient communication and improve both adherence to and efficacy of treatment. For these reasons, the development and validation of a new tool is necessary not only for future researches, but for use in standard clinical practice.
The first phase of the development of the questionnaire has already been completed. The second phase of the development of the questionnaire has been designed at to validate the tool in the Spanish population.
This study aims to assess the measurement properties of a new tool which assesses the impact of daily life in Rheumatoid Arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-group studies | Patients with RA diagnosed |
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| Measure | Description | Time Frame |
|---|---|---|
| Validation of a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in patient's perspective. | To validate (evaluate measurement properties) a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in routine clinical practice | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| the feasibility of the questionnaire by non-response rate and the time required to complete it | To assess the feasibility of the questionnaire by non-response rate and the time required to complete it | 10 months |
| the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity). |
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Inclusion Criteria:
Patients over 18 years old.
Patients with RA diagnosed according to the standards of the ACR (American College of Rheumatology) in 1987 or to the ACR/EULAR in 2010
Patients on treatment with any Rheumatoid Arthritis drug for at least 3 months before their inclusion in the study *
Patients who have provided informed consent prior to taking part in the study.
Exclusion Criteria:
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Patients diagnosed with Rheumatoid Arthritis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoni Gomez Centeno, MD | Contact | 0034937496300 | 6371 | msarmiento@es.imshealth.com |
| Monica Sarmiento | Contact | 0034937496300 | 6371 | msarmiento@es.imshealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Antoni Gomez Centeno | Hospital Corporacio Parc Tauli | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínic | Recruiting | Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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To assess the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity |
| 10 months |
| the reliability of the questionnaire in terms of internal consistency | To assess the reliability of the questionnaire in terms of internal consistency | 10 months |
| describe socio-demographic and clinical features of the patients recruited in the study. | To describe socio-demographic and clinical features of the patients recruited in the study. | 10 months |
| the adverse reactions (AR) reported by patients impact in the daily life. | To assess the adverse reactions (AR) reported by patients impact in the daily life | 10 months |
| correlation between the tolerability questionnaire and the patient satisfaction | To assess the correlation between the tolerability questionnaire and the patient satisfaction (ARTS questionnaire) | 10 months |
| Hospital Moisés Broggi | Recruiting | Sant Joan Despí | Barcelona | 08970 | Spain |
|
| Hospital Can Misses | Recruiting | Ibiza Town | Ibiza | 07800 | Spain |
|
| Hospital Son Espases | Recruiting | Mallorca | Mallorca | 07010 | Spain |
|
| Hospital Son Llàtzer | Recruiting | Mallorca | Mallorca | 07198 | Spain |
|
| Hospital Corporacio Sanitaria Parc Tauli | Recruiting | Sabadell | Spain | 08208 | Spain |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |