Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?
REVECHO
REVECHO Study (REmission Véritable en ECHOgraphie) Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?
1 other identifier
interventional
450
1 country
1
Brief Summary
Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks to a large choice of therapies, early treatment and tight control (30% relapse). Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may improve the prognosis of RA in remission by increasing the duration of sustained remission and by preventing radiographic structural progression. The tested hypothesis is: The US coverage of RA allows to increase the duration of sustained clinical remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Oct 2014
Typical duration for not_applicable rheumatoid-arthritis
1 active site
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
First Submitted
Initial submission to the registry
May 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 16, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedNovember 20, 2017
November 1, 2017
4 years
May 7, 2014
November 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to loss of remission, as clinically defined by a DAS28 score ≥2.6
The DAS28 (Disease Activity Score for Rheumatoid Arthritis) score is calculated on the basis of swollen joint count (SJC) and tender joint count (TJC) out of 28 (shoulder, elbow, wrist, metacarpophalangeal (MCP) I-V, proximal interphalangeal (PIP) I-V, and knee) as follows: DAS28-CRP= 0.56 x √TJC + 0.28 x √SJC + 0.36 x Ln (CRP + 1) + 0.014 x GA + 0.96 As a result, the DAS28 index gives a value between 0 and 10, with: * \>5.1 indicating high disease activity * 3.2-5.1 indicating moderate disease activity * \<3.2 indicating low disease activity * \<2.6 complete remission
Up to 18 months
Secondary Outcomes (3)
Percentage of RA patients in clinical remission (DAS28 <2.6) at 18 months
18 months
Percentage of RA patients without radiographic structural progression
18 months
Evolution of the RAPID score and HAQ
18 months
Study Arms (3)
Usual care
ACTIVE COMPARATORUsual care and follow-up every 3 months
US-driven therapy
EXPERIMENTALClinical evaluation according to DAS28 + US every 3 months
ACR/EULAR remission criteria-driven therapy
ACTIVE COMPARATORClinical evaluation according to DAS28 + ACR/EULAR remission criteria every 3 months
Interventions
Clinical evaluation according to DAS28 and US every 3 months. US examination is realized in B and Doppler power mode for each studied joint: Ankles, shoulders, elbows, wrists, MCP 1 to 5, PIP 1 to 5, knees and MTP 1 to 5.
Clinical evaluation and follow-up according to the practice of the referring rheumatologist every 3 months
Evaluation based on clinical evaluation according to DAS28 and ACR/EULAR remission criteria every 3 months.
Eligibility Criteria
You may qualify if:
- RA patients (ACR 2010 criteria)
- Disease duration ≤12 years
- Patients of both genders above 18 years old
- Remission according to DAS28 criteria (DAS28\<2.6) since at least 3 months
- Treated with DMARDS and/or biologics with stable posology since at least 3 months
- Treated with corticosteroids ≤5 mg/day (oral, local intra-articular or perfusion) since at least 3 months
- Affiliated to a regimen of health insurance (only for French sites)
- Having signed a consent form
- The patient is considered reliable, willing and capable of adhering to the protocol (for example, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
You may not qualify if:
- Pregnant women
- Predictable difficulties of follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- Pfizercollaborator
Study Sites (1)
Rheumatology Department, Ambroise Paré Hospital
Boulogne, Hauts DE Seine, 92104, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maria-Antonietta D'AGOSTINO, MD, PhD
Rheumatology Department, Ambroise Paré Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2014
First Posted
May 16, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
November 20, 2017
Record last verified: 2017-11