Rheumatoid Arthritis Response to Methotrexate

Rheumatoid Arthritis Clinical Trial

Official title:

Rheumatoid Arthritis Ultrasound Response to Methotrexate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03535519
• Other study ID #: Reuma-01-2017
• Status: Recruiting
• Start date: August 7, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2019
• Source: Hospital General Universitario Gregorio Marañon
• Contact: Juan Carlos Nieto González, PhD
• Phone: +34637723549
• Email: juancarlos.nietog[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active rheumatoid arthritis fulfilling EULAR criteria.

• Prescription of methotrexate by a rheumatologist.

• Informed consent signed by the patient.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate
standard of care treatment with methotrexate

Locations

Country	Name	City	State
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Juan Carlos Nieto	Nordic Pharma SAS

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound response	Change in B mode and Doppler mode synovitis and tenosynovitis	Basal and at 6 months
Secondary	Clinical response	Change in disease activity measured by DAS28, CDAI and SDAI	Basal and 6 months
Secondary	Functional response	Change in functional status measured by HAQ	Basal and 6 months