Reduced Ultrasound Counts in Rheumatoid Arthritis

NCT02389283 | Unknown

• 1 other identifier: FIBHGM-EONC004-2014
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; ultrasound joint count

Outcome Measures

Primary Outcomes (1)

• 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)

  at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD

Secondary Outcomes (1)

• Dopler Ultrasound sensitivity to change comparison

  at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Hopsital general Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• ESPERANZA NAREDO, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ESPERANZA NAREDO, PhD

CONTACT

enaredo@ser.es

Juan Carlos Nieto, MD

CONTACT

juancarlos.nietog@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

ES (1)