Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGMethotrexate
standard of care treatment with methotrexate
Sponsors
Nordic Pharma SAS
Juan Carlos Nieto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Active rheumatoid arthritis fulfilling EULAR criteria. * Prescription of methotrexate by a rheumatologist. * Informed consent signed by the patient.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound response | Basal and at 6 months | Change in B mode and Doppler mode synovitis and tenosynovitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Contacts
Primary ContactJuan Carlos Nieto González, PhD
Outcome results
None listed