Rheumatoid Arthritis Response to Methotrexate

NCT ID: NCT03535519

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-07

Study Completion Date

2020-08-31

Brief Summary

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

Detailed Description

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* 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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Methotrexate

standard of care treatment with methotrexate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nordic Pharma SAS

INDUSTRY

Sponsor Role collaborator

Juan Carlos Nieto

OTHER

Sponsor Role lead

Responsible Party

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Juan Carlos Nieto

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Juan Carlos Nieto González, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Universitario Gregorio Maranon

Locations

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Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Juan Carlos Nieto González, PhD

Role: CONTACT

+34637723549

Facility Contacts

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Juan Carlos Nieto González, PhD

Role: primary

Other Identifiers

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Reuma-01-2017

Identifier Type: -

Identifier Source: org_study_id

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