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Completed

NCT Number: NCT04752748

Power Doppler in Hand Joints of Early RA Patients

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.

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Key information

Conditions

Early Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in Synovial blood flow (power doppler)

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured in ultrasound examination

Secondary outcomes

  1. Change in Synovial Proliferation

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured in ultrasound examination

  2. Changes in Tenosynovitis

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured in ultrasound examination

  3. Changes in Joint Damage

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured in ultrasound examination

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

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured in blood test

  5. Changes in erythrocyte sedimentation rate level (mm/hour)

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured in blood test

  6. Changes in function

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured by Health Assessment Questionnaire

  7. Changes in upper limb function

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured by Disabilities of the Arm, Shoulder and Hand Questionnaire

  8. Changes in disease activity score

    Time frame: Baseline, after 4, 12, 24 and 48 weeks

    Measured by disease activity score 28

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Feb 12, 2021
Registry last updated
Feb 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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