Reduced Ultrasound Counts in Rheumatoid Arthritis

April 17, 2017 updated by: Hospital General Universitario Gregorio Marañon

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD

Secondary Outcome Measures

Outcome Measure
Time Frame
Dopler Ultrasound sensitivity to change comparison
Time Frame: at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD
at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Gregorio Marañon

Collaborators

Roche Pharma AG

Investigators

  • Principal Investigator: ESPERANZA NAREDO, PhD, Hospital General Universitario Gregorio Maranon

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 (Actual)

March 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

March 10, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 17, 2015

Study Record Updates

Last Update Posted (Actual)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBHGM-EONC004-2014

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.

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