Rheumatoid Arthritis Response to Methotrexate

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT03535519
• Lead Sponsor: Juan Carlos Nieto

Brief Summary

Observational and prospective study of the ultrasound response to methotrexate in rheumatoid arthritis patients who started methotrexate

Detailed Description

* Rheumatoid arthritis patients with active disease who start subcutaneous methotrexate by their rheumatologist prescription methotrexate will be included.

* Patients will participate in a prospective and observational study in which the response to methotrexate will be assessed by ultrasound (US) of joints and tendons.

* The main objective of the study is the change in B mode and Doppler mode US after 24 weeks of methotrexate treatment.

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-24
• Study Start: 2018-08-07
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Active rheumatoid arthritis fulfilling EULAR criteria.
• Prescription of methotrexate by a rheumatologist.
• Informed consent signed by the patient.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound response	Basal and at 6 months	Change in B mode and Doppler mode synovitis and tenosynovitis

Secondary Outcome Measures

Name	Time	Method
Clinical response	Basal and 6 months	Change in disease activity measured by DAS28, CDAI and SDAI
Functional response	Basal and 6 months	Change in functional status measured by HAQ

Trial Locations

Locations (1)

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain