Power Doppler in Hand Joints of Early RA Patients

Early Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752748
• Other study ID #: 106108
• Status: Completed
• Start date: August 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2021
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Early Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

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