NCT03535519

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

August 7, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2.1 years

First QC Date

May 14, 2018

Last Update Submit

August 5, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Ultrasound response

    Change in B mode and Doppler mode synovitis and tenosynovitis

    Basal and at 6 months

Secondary Outcomes (2)

  • Clinical response

    Basal and 6 months

  • Functional response

    Basal and 6 months

Interventions

MethotrexateDRUG

standard of care treatment with methotrexate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rheumatoid arthritis fulfilling EULAR criteria with active disease

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Juan Carlos Nieto González, PhD

    Hospital General Universitario Gregorio Maranon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Carlos Nieto González, PhD

CONTACT

+34637723549juancarlos.nietog@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 24, 2018

Study Start

August 7, 2018

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)