- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00794118
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose) (DOSE)
June 20, 2019 updated by: Pfizer
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study
The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients.
Data will be collected only from subjects providing informed consent.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
299
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Roma, Italy, 00161
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic
Description
Inclusion Criteria:
- Eighteen years of age or older
Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:
- Morning stiffness in and around the joints lasting at least 1 hour;
- Arthritis of 3 or more joint areas;
- Arthritis of hand joints;
- Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
- Rheumatoid nodules;
- Serum Rheumatoid Factor (RF)
- Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
- Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
- Patients naive to anti-TNF drugs
- Outpatients
Exclusion Criteria:
Patients involved in controlled or interventional trials in the 12 previous months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1.0
As per routinary clinical practice
|
As per clinical practice
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Erythrocyte Sedimentation Rate (ESR) at Month 6
Time Frame: Month 6
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hr.
A higher rate is consistent with inflammation.
|
Month 6
|
Erythrocyte Sedimentation Rate (ESR) at Month 12
Time Frame: Month 12
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hr.
A higher rate is consistent with inflammation.
|
Month 12
|
Duration of Morning Stiffness at Month 6
Time Frame: Month 6
|
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Month 6
|
Duration of Morning Stiffness at Month 12
Time Frame: Month 12
|
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Month 12
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3
Time Frame: Month 3
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity.
A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.
|
Month 3
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6
Time Frame: Month 6
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
A participant is considered to be in remission if they have a DAS28 <2.6.
|
Month 6
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9
Time Frame: Month 9
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
A participant is considered to be in remission if they have a DAS28 <2.6.
|
Month 9
|
Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12
Time Frame: Month 12
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
A participant is considered to be in remission if they have a DAS28 < 2.6.
|
Month 12
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 3
Time Frame: Month 3
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
|
Month 3
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
Time Frame: Month 6
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
|
Month 6
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 9
Time Frame: Month 9
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
|
Month 9
|
Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
Time Frame: Month 12
|
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
DAS28 <=3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
|
Month 12
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 3
Time Frame: Month 3
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
|
Month 3
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 6
Time Frame: Month 6
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
|
Month 6
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 9
Time Frame: Month 9
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
|
Month 9
|
Patient Global Assessment (PtGA) of Disease Activity Score at Month 12
Time Frame: Month 12
|
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
|
Month 12
|
Physician Global Assessment (PGA) of Disease Activity at Month 3
Time Frame: Month 3
|
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
|
Month 3
|
Physician Global Assessment (PGA) of Disease Activity at Month 6
Time Frame: Month 6
|
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
|
Month 6
|
Physician Global Assessment (PGA) of Disease Activity at Month 9
Time Frame: Month 9
|
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
|
Month 9
|
Physician Global Assessment (PGA) of Disease Activity at Month 12
Time Frame: Month 12
|
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
|
Month 12
|
Visual Analogue Scale for Pain (VAS-pain) at Month 3
Time Frame: Month 3
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
|
Month 3
|
Visual Analogue Scale for Pain (VAS-pain) at Month 6
Time Frame: Month 6
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
|
Month 6
|
Visual Analogue Scale for Pain (VAS-pain) at Month 9
Time Frame: Month 9
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
|
Month 9
|
Visual Analogue Scale for Pain (VAS-pain) at Month 12
Time Frame: Month 12
|
10 cm line (VAS) marked by participant.
Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
|
Month 12
|
C-reactive Protein (CRP) at Month 3
Time Frame: Month 3
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 3
|
C-reactive Protein (CRP) at Month 6
Time Frame: Month 6
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 6
|
C-reactive Protein (CRP) at Month 9
Time Frame: Month 9
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 9
|
C-reactive Protein (CRP) at Month 12
Time Frame: Month 12
|
CRP is a marker of inflammation.
CRP value higher than 0.5 mg/dL is consistent with inflammation.
|
Month 12
|
Erythrocyte Sedimentation Rate (ESR) at Month 3
Time Frame: Month 3
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hr.
A higher rate is consistent with inflammation.
|
Month 3
|
Erythrocyte Sedimentation Rate (ESR) at Month 9
Time Frame: Month 9
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hr.
A higher rate is consistent with inflammation.
|
Month 9
|
Number of Participants With Rheumatoid Factor (RF) at Month 3
Time Frame: Month 3
|
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma.
RF value higher than 20 U/mL is considered positive.
|
Month 3
|
Number of Participants With Rheumatoid Factor (RF) at Month 6
Time Frame: Month 6
|
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma.
RF value higher than 20 U/mL is considered positive.
|
Month 6
|
Number of Participants With Rheumatoid Factor (RF) at Month 9
Time Frame: Month 9
|
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma.
RF value higher than 20 U/mL is considered positive.
|
Month 9
|
Number of Participants With Rheumatoid Factor (RF) at Month 12
Time Frame: Month 12
|
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma.
RF value higher than 20 U/mL is considered positive.
|
Month 12
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3
Time Frame: Month 3
|
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Anti-CCP antibodies value higher than 10 U/mL is considered positive.
|
Month 3
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6
Time Frame: Month 6
|
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Anti-CCP antibodies value higher than 10 U/mL is considered positive.
|
Month 6
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9
Time Frame: Month 9
|
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Anti-CCP antibodies value higher than 10 U/mL is considered positive.
|
Month 9
|
Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12
Time Frame: Month 12
|
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
Anti-CCP antibodies value higher than 10 U/mL is considered positive.
|
Month 12
|
Number of Participants With Anti-nuclear Antibodies at Month 3
Time Frame: Month 3
|
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease.
Anti-nuclear antibodies value higher than 1:160 is considered positive.
|
Month 3
|
Number of Participants With Anti-nuclear Antibodies at Month 6
Time Frame: Month 6
|
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease.
Anti-nuclear antibodies value higher than 1:160 is considered positive.
|
Month 6
|
Number of Participants With Anti-nuclear Antibodies at Month 9
Time Frame: Month 9
|
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease.
Anti-nuclear antibodies value higher than 1:160 is considered positive.
|
Month 9
|
Number of Participants With Anti-nuclear Antibodies at Month 12
Time Frame: Month 12
|
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease.
Anti-nuclear antibodies value higher than 1:160 is considered positive.
|
Month 12
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3
Time Frame: Month 3
|
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease.
Anti-DNA antibodies value higher than 1:20 is considered positive.
|
Month 3
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6
Time Frame: Month 6
|
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease.
Anti-DNA antibodies value higher than 1:20 is considered positive.
|
Month 6
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9
Time Frame: Month 9
|
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease.
Anti-DNA antibodies value higher than 1:20 is considered positive.
|
Month 9
|
Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12
Time Frame: Month 12
|
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease.
Anti-DNA antibodies value higher than 1:20 is considered positive.
|
Month 12
|
Duration of Morning Stiffness at Month 3
Time Frame: Month 3
|
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Month 3
|
Duration of Morning Stiffness at Month 9
Time Frame: Month 9
|
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes.
Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Month 9
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 3
Time Frame: Month 3
|
HAQ is a measure of functional limitations.
Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities.
The higher score reported by the participant for any component question of the 8 categories determines the score for that categories.
Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
|
Month 3
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 6
Time Frame: Month 6
|
HAQ is a measure of functional limitations.
Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities.
The higher score reported by the participant for any component question of the 8 categories determines the score for that categories.
Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
|
Month 6
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 9
Time Frame: Month 9
|
HAQ is a measure of functional limitations.
Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities.
The higher score reported by the participant for any component question of the 8 categories determines the score for that categories.
Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
|
Month 9
|
Stanford Health Assessment Questionnaire (HAQ) Score at Month 12
Time Frame: Month 12
|
HAQ is a measure of functional limitations.
Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities.
The higher score reported by the participant for any component question of the 8 categories determines the score for that categories.
Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
|
Month 12
|
36-Item Short-Form Health Survey (SF-36) at Month 12
Time Frame: Month 12
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
|
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Direct Costs
Time Frame: Baseline, Months 3, 6, 9 and 12
|
Direct costs included all expenses requiring actual payment or time spent due to the disease itself or to disability.
|
Baseline, Months 3, 6, 9 and 12
|
Indirect Costs
Time Frame: Baseline, Months 3, 6, 9 and 12
|
Indirect costs represent the loss of resources as a consequence of work disability or unemployment.
|
Baseline, Months 3, 6, 9 and 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
November 17, 2008
First Submitted That Met QC Criteria
November 18, 2008
First Posted (Estimate)
November 19, 2008
Study Record Updates
Last Update Posted (Actual)
July 1, 2019
Last Update Submitted That Met QC Criteria
June 20, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0881A1-102321
- B1801119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
-
University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
-
David Grant U.S. Air Force Medical CenterCompleted
-
TcLand Expression S.A.European CommissionTerminatedRheumatoId ArthritisFrance, Netherlands, Turkey, Czechia, Israel
Clinical Trials on As per clinical practice
-
Danone Nutricia SpA Società BenefitRecruitingAutism Spectrum Disorder | Drug Resistant Epilepsy | Chronic Migraine | Brain Tumor, PediatricItaly
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedRheumatoid ArthritisItaly
-
Singapore General HospitalDSO National Laboratories; Health Sciences Authority, SingaporeCompletedHypoproliferative ThrombocytopeniaSingapore
-
Università Vita-Salute San RaffaeleRecruitingAcute Respiratory Distress Syndrome | BarotraumaItaly
-
PfizerCompleted
-
Instituto de Atención PediátricaPfizer; Ben-Gurion University of the NegevSuspended
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaOspedale SS Giovanni e Paolo, VeneziaRecruiting
-
Amsterdam UMC, location VUmcCompleted
-
Basque Health ServiceCompleted
-
Corporacion Parc TauliRecruitingSimulation | Learning | Students, Medical | Feedback | Competency-based EducationSpain