Rheumatoid ArthritisNCT01050010
The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission. Preliminary Study
A study testing MRI in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
Trial summary
The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. Numerous definitions of the remission proposed by literature remain imperfect. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2010to Apr 2012
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Earlier rheumatoid arthritis (<1 year)
- Clinical remission (DAS 28 <2,6 ou SDAI <5) since 6 months before the inclusion
- Unchanged DMARds and /or biologic therapy since 6 months before the inclusion
- Unchanged corticosteroid (5 mg/day) since 3 months before the inclusion in patients treated with this therapy
- No contre-indication to the MRI
Who cannot join
- Contra-indication to MRI
- Pregnant or breast-feeding women
Trial locations and contacts
2 sites in 1 country.
Christine ALBERT-SABONNADIERE, PhD contact
France2 sites, 2 recruiting
- Recruiting
CHU de NICE
Nice, 06000
Christine ALBERT-SABONNADIERE, M.D., 0492035481
Christine ALBERT-SABONNADIERE, M.D.
- Not yet recruiting
Rheumatology Department, Nice University Hospital
Nice, 06000
Christine ALBERT-SABONNADIERE, PhD, albert-sabonnadiere.c@chu-nice.fr
About this study
Official title: The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study
The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. Numerous definitions of the remission proposed by literature remain imperfect.
Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid arthritis.
Read more
Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and ultrasonography synovitis, 45% of cases with synovial activity.
To our knowledge, in such case few studies showed correlation between persistent imaging synovitis and structural radiographic progression.
On the other hand, no studies with extremity dedicated RMI in patients with remission are reported.
In this preliminary study, the investigators propose to evaluate in patients with rheumatoid arthritis remission and persistent dedicated MRI synovitis the structural radiographic progression at one year.
- Conditions
- Rheumatoid Arthritis
- Being tested
- MRI
- Keywords
- rheumatoid arthritis, clinical remission, synovitis, dedicated extremity MRI
- Medical subject headings
- Arthritis, Rheumatoid, Synovitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
dedicated extremity MRI
| Study group | Role | What they receive |
|---|---|---|
| Dedicated extremity MRI | Other | Structural deterioration radiographic assessed by dedicated extremity MRI Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot)
Measured: at Month 0 (first visit) and Month 12 (last visit)
Secondary outcomes (1)
Ultrasonography (hand, wrist and foot)
Measured: at Month 0 (first vist) and Month 12 (last visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2010
- Study completionApr 2012 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine ALBERT-SABONNADIERE, PhD, Principal investigator, Nice University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050010
- Sponsor's protocol ID
- 09-CIR-01
- Status last verified
- Dec 2011
- First submitted
- 14 Jan 2010
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study
- ClinicalTrials.gov ID
- NCT01050010
- Acronym / sponsor ID
- 09-CIR-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, clinical remission, synovitis, dedicated extremity MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2012 (estimated)
- First posted
- 15 Jan 2010 (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 major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. Numerous definitions of the remission proposed by literature remain imperfect.
Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid arthritis.
Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and ultrasonography synovitis, 45% of cases with synovial activity.
To our knowledge, in such case few studies showed correlation between persistent imaging synovitis and structural radiographic progression.
On the other hand, no studies with extremity dedicated RMI in patients with remission are reported.
In this preliminary study, the investigators propose to evaluate in patients with rheumatoid arthritis remission and persistent dedicated MRI synovitis the structural radiographic progression at one year.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dedicated extremity MRI | Other | Other: MRIStructural deterioration radiographic assessed by dedicated extremity MRI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Earlier rheumatoid arthritis (<1 year)
- Clinical remission (DAS 28 <2,6 ou SDAI <5) since 6 months before the inclusion
- Unchanged DMARds and /or biologic therapy since 6 months before the inclusion
- Unchanged corticosteroid (5 mg/day) since 3 months before the inclusion in patients treated with this therapy
- No contre-indication to the MRI
Key exclusion criteria (2 listed)
- Contra-indication to MRI
- Pregnant or breast-feeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIdedicated extremity MRI | Other | Dedicated extremity MRI |
Primary outcome
Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot)
Time frame: at Month 0 (first visit) and Month 12 (last visit)
1 secondary outcome
Ultrasonography (hand, wrist and foot)
Time frame: at Month 0 (first vist) and Month 12 (last visit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
Related trials for Rheumatoid Arthritis
Active, not recruitingObservational study
Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries
Rheumatoid Arthritis, Ankylosing Spondylitis
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 2
A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE
Sjögren's Syndrome
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
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.
Christine ALBERT-SABONNADIERE, PhD contact
Christine ALBERT-SABONNADIERE, PhD principal investigator
Nice University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.
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 2 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 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 Christine ALBERT-SABONNADIERE, PhD (albert-sabonnadiere.c@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot) (time frame: at Month 0 (first visit) and Month 12 (last visit)). 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 9 Dec 2011.