Rheumatoid Arthritis in Remission Clinical Trial
— SONOREOfficial title:
Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study
| NCT number | NCT02618954 |
| Other study ID # | 9186 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2013 |
| Est. completion date | July 2016 |
| Verified date | June 2018 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The objective of this study is to determine the longitudinal relation between clinical
remission and ultrasound (US) remission in Rheumatoid arthritis (RA).
At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals
and power Doppler signals) is frequent in patients with RA in clinical remission. Several
longitudinal studies reveal an association of US-detected residual synovitis and risk of
relapse and radiographic progression, in individual patients and joints, over 1-2 years.
However, the longitudinal relation between clinical remission and US remission is not so
well-known and it is possible that clinical remission arrive before ultrasound remission.
Thus arise the question as to whether the presence of US-detected residual synovitis require
to adapt the treatment to ultrasound findings or to simply increase the patient care.
The investigator propose to conduct a prospective, bi-center, non randomized study.
| Status | Completed |
| Enrollment | 116 |
| Est. completion date | July 2016 |
| Est. primary completion date | July 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age = 18 years - PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria - Patient treated by DMARDs (disease-modifying antirheumatic drug) - Patient in confirmed remission for less than 6 months Exclusion Criteria: - Patient participating simultaneously in another clinical study with blind treatment - Patient participating simultaneously in another clinical study involving decreasing of drug dose - Patient in post clinical study exclusion period - patients subject to legal protection measures - Patient unable to read French - Pregnant or breast-feeding women - patient treated with Rituximab |
| Country | Name | City | State |
|---|---|---|---|
| France | Montpellier University Hospital | Montpellier | Herault |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 1 year pejorative evolution | Number of patient with a clinical relapse | 1 year after inclusion | |
| Secondary | Structural progression | Number of patient with a structural progression of the illness | 1 year after inclusion | |
| Secondary | RA (Rheumatoid Arthritis) remission duration | Evaluation of the remission duration (patient in both clinical and ultrasound remission) | At each follow-up (3,6,9 and 12 months after inclusion) | |
| Secondary | RA ultrasound remission duration | Evaluation of the ultrasound remission duration | At each follow-up (3,6,9 and 12 months after inclusion) | |
| Secondary | RA clinical remission duration | Evaluation of the clinical remission duration | At each follow-up (3,6,9 and 12 months after inclusion) | |
| Secondary | Clinical relapse at one year | Evaluation of the probability of a clinical relapse at 1 year based on the ultrasound data | 1 year after inclusion | |
| Secondary | Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments) | identifying initial factors that can explain persistence of ultrasound synovitis despite clinical remission | At baseline | |
| Secondary | Radiographic progression at 1 year | Evaluation at joint level the probability of a radiographic progression in presence of a non active synovitis | 1 year after inclusion | |
| Secondary | Intra-observator reproductibility | Evaluating the intra-observer reliability for US synovitis through study completion | 1 year after inclusion |