Reduced Ultrasound Counts in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Sensitivity to Change of Different Reduced Ultrasound Counts in Rheumatoid Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02389283
• Other study ID #: FIBHGM-EONC004-2014
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2015
• Last updated: April 17, 2017
• Start date: March 2015
• Est. completion date: June 2017

Study information

• Verified date: April 2017
• Source: Hospital General Universitario Gregorio Marañon
• Contact: ESPERANZA NAREDO, PhD
• Email: enaredo[@]ser.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Spain	Hopsital general Universitario Gregorio Marañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital General Universitario Gregorio Marañon	Roche Pharma AG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dopler Ultrasound sensitivity to change comparison		at baseline and 1, 3 and 6 months after the initiation with the biologic DMARD