Rheumatoid ArthritisNCT02389283
Reduced Ultrasound Counts in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones, joint capsule, tendons and ligaments leading to the consequential functional joint deterioration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Jun 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid arthritis patients with more than 6 months and less than 5 years of active evolution (DAS28 > 3.2 or SDAI > 11) and which start treatment with biologic therapy for the first time independently of the combination with synthetic DMARDs. The patients will be evaluated according to clinical practice (clinical evaluation and inflammation markers) at baseline and 3 and 6 months after the initiation of the treatment with the biologic DMARD.
Who may be able to join
- Patients of both genders, ≥ 18 years of age
- Patients diagnosed with RA (according to the ACR 2010 criteria) with more than 6 months and less than 5 years of active evolution and DAS28 > 3.2 or SDAI > 11, which start treatment with biologic DMARD for the first time, according to the product's summary of products characteristics (SPC).
- Patients who have granted their written informed consent for the collection and review of their data.
Who cannot join
- Patients who are already participating in a clinical trial/s at the moment of participation in this study.
- Patients with rheumatic disease other than RA
Trial locations and contacts
1 site in 1 country.
ESPERANZA NAREDO, PhD contact
Juan Carlos Nieto, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hopsital general Universitario Gregorio Marañón
Madrid, Madrid, 28007
Esperanza Naredo, PhD, enaredo@ser.es
Juan Carlos Nieto, MD, juancarlos.nietog@gmail.com
About this study
Official title: Sensitivity to Change of Different Reduced Ultrasound Counts in Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones, joint capsule, tendons and ligaments leading to the consequential functional joint deterioration.
The main goal of RA treatment is to achieve disease remission. The treatment of RA consists of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected when low disease or remission is not achieved with the first ones. Therapeutic response monitoring in RA should be closely managed. It is classically based on clinical exploration and laboratory tests. During the last decade, the resolution improvement of musculoskeletal ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the evaluation and monitoring of patients with RA, mainly due to its better capacity to detect synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive, reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects pathological synovial flow, which reflects synovial inflammation and has a demonstrated sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients with RA includes the detection of synovitis in B and Doppler mode in the joints accessible by ultrasound. There has been high variability in the literature regarding the number of joints that should be evaluated for an appropriate monitoring of the RA patients. The validity for monitoring the therapeutic response in long standing RA has been demonstrated in three reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution RA, the sensitivity to change of any of these reduced ultrasound evaluations has never been studied
Read the detailed description
Primary objectives
- To evaluate the sensitivity to change of the Doppler Ultrasound evaluation of 12, 7 and 6 joints counts in RA patients with more than 6 months and less than 5 years of evolution, which initiate an effective treatment for the disease according to indication (biologic DMARD in monotherapy or combined with methotrexate).
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, ultrasound joint count
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid arthritis(RA) patients | The patients will be evaluated according to clinical practice (clinical evaluation and inflammation markers) at baseline and 3 and 6 months after the initiation of the treatment with the biologic DMARD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode B and power Doppler (PD) ultrasound evaluation
Mode B and PD ultrasound evaluation will consist in quantifying the synovitis (0 to 3) in B mode (synovial hypertrophy, effusion) and PD with quantification system OMERACT (Outcome Measures in Rheumatology) in the following bilateral joints:
- Elbows (anterior and posterior recess)
- Carpi (radiocarpal and midcarpal + carpoulnar) (dorsal recess)
- Second and third metacarpophalangeal (dorsal recess)
- Second and third proximal interphalangeal of hands (dorsal and palmar recesses)
- Knees (suprapatellar and parapatelallar recesses)
- Tibiotalar (dorsal and lateral recesses)
- Second and fifth metatarsophalangeal (dorsal recess)
Measured: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD
Secondary outcomes (1)
Dopler Ultrasound sensitivity to change comparison
Measured: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2017
- Study completionJun 2017 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- ESPERANZA NAREDO, PhD, Principal investigator, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389283
- Sponsor's protocol ID
- FIBHGM-EONC004-2014
- Status last verified
- Apr 2017
- First submitted
- 10 Mar 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity to Change of Different Reduced Ultrasound Counts in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02389283
- Acronym / sponsor ID
- FIBHGM-EONC004-2014
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis, ultrasound joint count
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Mar 2015 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 17 Mar 2015 (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.
Rheumatoid arthritis (RA) is a chronic inflammatory disease characterized by intra and peri-articular synovial inflammation. Synovitis can damage the articular cartilage, bones, joint capsule, tendons and ligaments leading to the consequential functional joint deterioration.
The main goal of RA treatment is to achieve disease remission. The treatment of RA consists of synthetic and biologic disease modifying drugs (DMARDs), being the second ones selected when low disease or remission is not achieved with the first ones. Therapeutic response monitoring in RA should be closely managed. It is classically based on clinical exploration and laboratory tests. During the last decade, the resolution improvement of musculoskeletal ultrasound (MSUS) imaging has led to the gradual incorporation of this technique in the evaluation and monitoring of patients with RA, mainly due to its better capacity to detect synovitis than clinical exploration . Ultrasound imaging is highly available, non-invasive, reproducible, affordable and well accepted by patients. Ultrasound doppler mode detects pathological synovial flow, which reflects synovial inflammation and has a demonstrated sensitivity to change in multiple longitudinal studies. Sonographic evaluation of patients with RA includes the detection of synovitis in B and Doppler mode in the joints accessible by ultrasound. There has been high variability in the literature regarding the number of joints that should be evaluated for an appropriate monitoring of the RA patients. The validity for monitoring the therapeutic response in long standing RA has been demonstrated in three reduced joint counts, including 12, 7 and 6 joints. However, in shorter evolution RA, the sensitivity to change of any of these reduced ultrasound evaluations has never been studied
Detailed description
Primary objectives
- To evaluate the sensitivity to change of the Doppler Ultrasound evaluation of 12, 7 and 6 joints counts in RA patients with more than 6 months and less than 5 years of evolution, which initiate an effective treatment for the disease according to indication (biologic DMARD in monotherapy or combined with methotrexate).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid arthritis(RA) patients | – | –The patients will be evaluated according to clinical practice (clinical evaluation and inflammation markers) at baseline and 3 and 6 months after the initiation of the treatment with the biologic DMARD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients with more than 6 months and less than 5 years of active evolution (DAS28 > 3.2 or SDAI > 11) and which start treatment with biologic therapy for the first time independently of the combination with synthetic DMARDs. The patients will be evaluated according to clinical practice (clinical evaluation and inflammation markers) at baseline and 3 and 6 months after the initiation of the treatment with the biologic DMARD.
Key inclusion criteria (3 listed)
- Patients of both genders, ≥ 18 years of age
- Patients diagnosed with RA (according to the ACR 2010 criteria) with more than 6 months and less than 5 years of active evolution and DAS28 > 3.2 or SDAI > 11, which start treatment with biologic DMARD for the first time, according to the product's summary of products characteristics (SPC).
- Patients who have granted their written informed consent for the collection and review of their data.
Key exclusion criteria (2 listed)
- Patients who are already participating in a clinical trial/s at the moment of participation in this study.
- Patients with rheumatic disease other than RA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mode B and power Doppler (PD) ultrasound evaluation
Time frame: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD
Mode B and PD ultrasound evaluation will consist in quantifying the synovitis (0 to 3) in B mode (synovial hypertrophy, effusion) and PD with quantification system OMERACT (Outcome Measures in Rheumatology) in the following bilateral joints: * Elbows (anterior and posterior recess) * Carpi (radiocarpal and midcarpal + carpoulnar) (dorsal recess) * Second and third metacarpophalangeal (dorsal recess) * Second and third proximal interphalangeal of hands (dorsal and palmar recesses) * Knees (suprapatellar and parapatelallar recesses) * Tibiotalar (dorsal and lateral recesses) * Second and fifth metatarsophalangeal (dorsal recess)
1 secondary outcome
Dopler Ultrasound sensitivity to change comparison
Time frame: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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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.
ESPERANZA NAREDO, PhD contact
Juan Carlos Nieto, MD contact
ESPERANZA NAREDO, PhD principal investigator
Hospital General Universitario Gregorio Marañon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 3 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 ESPERANZA NAREDO, PhD (enaredo@ser.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode B and power Doppler (PD) ultrasound evaluation (time frame: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD). 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 18 Apr 2017.