NCT02401620

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

March 19, 2015

Last Update Submit

March 24, 2015

Conditions

Rheumatoid Arthritis

Keywords

AR: arthritis rheumatoidDMARDs: Disease-modifying antirheumatic drugsACR. American College of RheumatologyEULAR: European League against rheumatology

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • 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).

    10 months

  • 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.

    10 months

  • the adverse reactions (AR) reported by patients impact in the daily life.

    10 months

  • +1 more secondary outcomes

Study Arms (1)

single-group studies

Patients with RA diagnosed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with Rheumatoid Arthritis

You may qualify if:

  • 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 who have provided informed consent prior to taking part in the study.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Clínic

Barcelona, Barcelona, 08036, Spain

RECRUITING

Hospital Moisés Broggi

Sant Joan Despí, Barcelona, 08970, Spain

RECRUITING

Hospital Can Misses

Ibiza Town, Ibiza, 07800, Spain

RECRUITING

Hospital Son Espases

Mallorca, Mallorca, 07010, Spain

RECRUITING

Hospital Son Llàtzer

Mallorca, Mallorca, 07198, Spain

RECRUITING

Hospital Corporacio Sanitaria Parc Tauli

Sabadell, Spain, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Antoni Gomez Centeno

    Hospital Corporacio Parc Tauli

    STUDY CHAIR

Central Study Contacts

Antoni Gomez Centeno, MD

CONTACT

0034937496300msarmiento@es.imshealth.com

Monica Sarmiento

CONTACT

0034937496300msarmiento@es.imshealth.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 30, 2015

Study Start

January 1, 2014

Primary Completion

April 1, 2015

Study Completion

December 1, 2015

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

ES(6)