Rheumatoid ArthritisNCT02401620
Validation of a Tolerability Questionnaire in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Corporacion Parc Tauli at 6 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 66 participants
- Where
- 6 sitesSpain
- Study dates
- Jan 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Rheumatoid Arthritis
Who may be able to join
- 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.
- It's not necessary for patients to be treated in first-line at the moment of the inclusion in the study.
Who cannot join
- 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.
- 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.
- 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.
- Patients who participated in interviews of the Phase I (development of the questionnaire)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites, 6 recruiting
- Recruiting
Hospital Clínic
Barcelona, Barcelona, 08036
Raimón Sanmartí
Raimón Sanmartí
- Recruiting
Hospital Can Misses
Ibiza Town, Ibiza, 07800
Ana Urruticoechea
Ana Urruticoechea
- Recruiting
Hospital Son Espases
Mallorca, Mallorca, 07010
Lluis Espadaler
Lluis Espadaler
- Recruiting
Hospital Son Llàtzer
Mallorca, Mallorca, 07198
Inmaculada Ros
Inmaculada Ros
- Recruiting
Hospital Corporacio Sanitaria Parc Tauli
Sabadell, Spain, 08208
Antoni Gomez Centeno
Antoni Gomez Centeno
- Recruiting
Hospital Moisés Broggi
Sant Joan Despí, Barcelona, 08970
Hector Coromines
Hector Coromines
About this study
Official title: Validation of a Specific Questionnaire to Assess the Tolerability of the Different Therapeutic Strategies in Rheumatoid Arthritis
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- AR: arthritis rheumatoid, DMARDs: Disease-modifying antirheumatic drugs, ACR. American College of Rheumatology, EULAR: European League against rheumatology
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| single-group studies | Patients with RA diagnosed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 months
Secondary outcomes (6)
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
Measured: 10 months
the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity).
To assess the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity
Measured: 10 months
the reliability of the questionnaire in terms of internal consistency
To assess the reliability of the questionnaire in terms of internal consistency
Measured: 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.
Measured: 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
Measured: 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)
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionApr 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio D Gómez-Centeno, Corporacion Parc Tauli
- Investigators
- Antoni Gomez Centeno, Study chair, Hospital Corporacio Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401620
- Sponsor's protocol ID
- FUN-TOC-2014-01
- Status last verified
- Mar 2015
- First submitted
- 19 Mar 2015
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Specific Questionnaire to Assess the Tolerability of the Different Therapeutic Strategies in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02401620
- Acronym / sponsor ID
- FUN-TOC-2014-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- AR: arthritis rheumatoid, DMARDs: Disease-modifying antirheumatic drugs, ACR. American College of Rheumatology, EULAR: European League against rheumatology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-group studies | – | –Patients with RA diagnosed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Rheumatoid Arthritis
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
- 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.
- 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.
- Patients who participated in interviews of the Phase I (development of the questionnaire)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validation of a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in patient's perspective.
Time frame: 10 months
To validate (evaluate measurement properties) a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in routine clinical practice
6 secondary outcomes
the feasibility of the questionnaire by non-response rate and the time required to complete it
Time frame: 10 months
the construct validity of the questionnaire analyzing the relation between questionnaire scores and clinical data (discriminant validity).
Time frame: 10 months
the reliability of the questionnaire in terms of internal consistency
Time frame: 10 months
describe socio-demographic and clinical features of the patients recruited in the study.
Time frame: 10 months
the adverse reactions (AR) reported by patients impact in the daily life.
Time frame: 10 months
correlation between the tolerability questionnaire and the patient satisfaction
Time frame: 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni Gomez Centeno study chair
Hospital Corporacio Parc Tauli
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Corporacion Parc Tauli at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoni Gomez Centeno, MD (0034937496300 ext. 6371, msarmiento@es.imshealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of a new questionnaire to measure the tolerability to the pharmacological treatment in RA patients in patient's perspective. (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.