NCT04540250

Brief Summary

This study included rheumatoid arthritis patients receiving Methotrexate as monotherapy. All eligible patients were subjected to thorough clinical examination and full history to identify oral events. Drug history, current dose and duration of MTX were recorded.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
804

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

August 1, 2020

Enrollment Period

2.6 years

First QC Date

August 18, 2020

Last Update Submit

August 31, 2020

Conditions

Methotrexate Adverse ReactionOral Mucositis

Outcome Measures

Primary Outcomes (1)

  • occurrence of oral mucositis

    Clinical examination (intra-oral) and history of oral mucositis where recorded

    throughout the study time (one year)

Study Arms (1)

Study group of Rheumatoid arthritis patients

RA patients receiving MTX as monotherapy were included in the study. Patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded.

Other: questionnaire

Interventions

questionnaireOTHER

conventional intra-oral examination and questionnaire

Also known as: intra-oral examination
Study group of Rheumatoid arthritis patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

RA patients receiving MTX as monotherapy were included in the study. Patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded.

You may qualify if:

  • patients with Rheumatoid arthritis using methotrexate as sole treatment

You may not qualify if:

  • patients with Rheumatoid arthritis using any other treatments for Rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomatitis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of oral medicine

Study Record Dates

First Submitted

August 18, 2020

First Posted

September 7, 2020

Study Start

January 1, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

September 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share