Clinical trial NCT02401620: Validation of a Tolerability Questionnaire in Rheumatoid Arthritis
Official title: Validation of a Specific Questionnaire to Assess the Tolerability of the Different Therapeutic Strategies in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Keywords: AR: arthritis rheumatoid
DMARDs: Disease-modifying antirheumatic drugs
ACR. American College of Rheumatology
EULAR: European League against rheumatology
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with Rheumatoid Arthritis

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years old.
2. Patients with RA diagnosed according to the standards of the ACR (American College of Rheumatology) in 1987 or to the ACR/EULAR in 2010
3. Patients on treatment with any Rheumatoid Arthritis drug for at least 3 months before their inclusion in the study \*
4. Patients who have provided informed consent prior to taking part in the study.

   * It's not necessary for patients to be treated in first-line at the moment of the inclusion in the study.

Exclusion Criteria:

1. Patients with rheumatic disease other than Rheumatoid Arthritis. Will be exclude patients with the following concomitant diseases: Rheumatic autoimmune disease other than RA; Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis; Diagnosis of juvenile idiopathic arthritis; inflammatory joint disease other than Rheumatoid Arthritis.
2. Patients with any other concomitant disease or treatment that, under clinical criteria, could affect the results of the study or any major episode of infection or disease requiring hospitalization.
3. Patients with any other medical or physiological condition that, in the view of the investigator, could compromise the ability of the patient to answer the study questions.
4. Patients who participated in interviews of the Phase I (development of the questionnaire)

Primary outcomes:
measure: Validation of a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in patient's perspective.
timeFrame: 10 months
Secondary outcomes:
measure: the feasibility of the questionnaire by non-response rate and the time required to complete it
timeFrame: 10 months
measure: the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity).
timeFrame: 10 months
measure: the reliability of the questionnaire in terms of internal consistency
timeFrame: 10 months
measure: describe socio-demographic and clinical features of the patients recruited in the study.
timeFrame: 10 months
measure: the adverse reactions (AR) reported by patients impact in the daily life.
timeFrame: 10 months
measure: correlation between the tolerability questionnaire and the patient satisfaction
timeFrame: 10 months
Other outcomes:
Locations:
city: Sant Joan Despí
country: Spain
facility: Hospital Moisés Broggi
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Ibiza
country: Spain
facility: Hospital Can Misses
city: Mallorca
country: Spain
facility: Hospital Son Espases
city: Mallorca
country: Spain
facility: Hospital Son Llàtzer
city: Sabadell
country: Spain
facility: Hospital Corporacio Sanitaria Parc Tauli
Study officials:
affiliation: Hospital Corporacio Parc Tauli
name: Antoni Gomez Centeno
role: STUDY_CHAIR
References: