Power Doppler in Hand Joints of Early RA Patients

Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment

It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three therapeutic failures were considered: failure 1 - to the first Disease-modifying antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide) and failure 3 - to the first immunobiological drugs (adalimumab). Ultrasound was performed bilaterally on the 2nd and 3rd metacarpophalangeal joints (MCFs), proximal interphalangeal joints (IFPs), and wrists (US10). Ultrasound measurements (qualitative and semi-quantitative) evaluated: 1 - inflammatory: synovial and tenosynovial proliferation in gray scale and power Doppler (0-3); 2 - joint damage: bone erosion (qualitative and semi-quantitative) and cartilage damage (qualitative and semi-quantitative). Clinical and laboratory variables were also assessed blindly at baseline and after 12, 24 e 48 weeks.

Study Overview

• Status: Completed
• Conditions: Early Rheumatoid Arthritis
• Intervention / Treatment: Drug: Drug protocol

• Study Type: Observational
• Enrollment (Actual): 48

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Woman diagnosed eith early rheumatoid arthritis naive for treatment

Description

Inclusion Criteria:

• early rheumatoid arthritis fulfilment of the 2010 ACR/EULAR RA classification criteria;
• age between 18-65 years;
• female gender,
• naive for treatment.

Exclusion Criteria:

• use of oral > 10 mg/d glucocorticoid in the previous three weeks;
• serum aspartate aminotransferase or alanine aminotransferase level > 3 times the upper limit of normal;
• bone marrow, auto-imune, lymphoproliferative or infectious diseases;
• pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Woman with Early Rheumatoid Arthritis

Drug: Drug protocol; The following drug scheme was carried out: The patients began with methotrexate (MTX) 15 mg / week, which was increased to 25 mg / week until week 12. Subsequent steps for patients with an insufficient response (DAS28 score> 3.2 and the Physician's Global Assessment (PGA)> 4.0 [0-10 cm]) were leflunomide 20mg / day with MTX 15 mg / week from week 12 to week 24 and adalimumab twice a month and MTX 15mg / week from week 24 to week 48. The use of 5mg folic acid was advised once a week during the 48 weeks of the study. Three treatment failures were considered over these 48 weeks: Failure 1: failure of the first DMARD (MTX) in week 12.; Failure 2: failure of the second DMARD (leflunomide) at week 24; Failure 3: failure of the first immunobiological (adalimumab) at week 48.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Synovial blood flow (power doppler)	Measured in ultrasound examination	Baseline, after 4, 12, 24 and 48 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Synovial Proliferation	Measured in ultrasound examination	Baseline, after 4, 12, 24 and 48 weeks
Changes in Tenosynovitis	Measured in ultrasound examination	Baseline, after 4, 12, 24 and 48 weeks
Changes in Joint Damage	Measured in ultrasound examination	Baseline, after 4, 12, 24 and 48 weeks
Changes in C-reactive protein level (mg/liter)	Measured in blood test	Baseline, after 4, 12, 24 and 48 weeks
Changes in erythrocyte sedimentation rate level (mm/hour)	Measured in blood test	Baseline, after 4, 12, 24 and 48 weeks
Changes in function	Measured by Health Assessment Questionnaire	Baseline, after 4, 12, 24 and 48 weeks
Changes in upper limb function	Measured by Disabilities of the Arm, Shoulder and Hand Questionnaire	Baseline, after 4, 12, 24 and 48 weeks
Changes in disease activity score	Measured by disease activity score 28	Baseline, after 4, 12, 24 and 48 weeks

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 106108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No