Power Doppler in Hand Joints of Early RA Patients

NCT04752748 | Completed DMC

• 1 other identifier: 106108
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Early Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Changes in Synovial blood flow (power doppler)

  Measured in ultrasound examination

  Baseline, after 4, 12, 24 and 48 weeks

Secondary Outcomes (8)

• Change in Synovial Proliferation

  Baseline, after 4, 12, 24 and 48 weeks

• Changes in Tenosynovitis

  Baseline, after 4, 12, 24 and 48 weeks

• Changes in Joint Damage

  Baseline, after 4, 12, 24 and 48 weeks

• Changes in C-reactive protein level (mg/liter)

  Baseline, after 4, 12, 24 and 48 weeks

• Changes in erythrocyte sedimentation rate level (mm/hour)

  Baseline, after 4, 12, 24 and 48 weeks

Study Arms (1)

Woman with Early Rheumatoid Arthritis

Drug: Drug protocol

Interventions

Drug protocol DRUG

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.

Woman with Early Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Woman diagnosed eith early rheumatoid arthritis naive for treatment

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Related Publications (1)

• da Luz KR, Natour J, Pinheiro MM, Petterle GS, Dos Santos MF, Fernandes ADRC, Furtado RNV. Power Doppler in hand joints predicts therapeutic failure in treatment-naive women with early rheumatoid arthritis: A prospective study. Clinics (Sao Paulo). 2025 Mar 1;80:100593. doi: 10.1016/j.clinsp.2025.100593. eCollection 2025.

  PMID: 40023888 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Drug Therapy, Computer-Assisted

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 12, 2021
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: February 17, 2021

Record last verified: 2021-02