NCT02327650

Brief Summary

Generally, osteoarthris (OA) is considered as primarily cartilage disease. However, as we and others have previously reported, a portion of OA might be caused primarily by bone alterations. In this study, we prospectively and retrospectively show that the bone altertations may affect OA primarily in all of the joints. In addition, rheumatoid arthritis (RA) is a joint disease when immune system attacks synovium. Joint destruction occurrs continuously if suitable treatment is not performed. The etiology of RA is still largely unknown. As with OA, RA can be primarily damaged in bone, instead of cartilage. Here we prospectively and retrospectively show that the bone altertations may affect RA primarily in all of the joints.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

December 21, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

6.4 years

First QC Date

December 21, 2014

Last Update Submit

September 20, 2021

Conditions

Progression of Rheumatoid ArthritisOsteoarthritis of Multiple Joints

Outcome Measures

Primary Outcomes (1)

  • The bone signal changes detected by MRI in OA and/or RA patients

    1 year

Study Arms (1)

RA and OA

Every 2 or 3 months, plain radiograph, blood and urinary tests, and MRI are performed in the painful joints of RA.

Procedure: The examinations for bones in joints of OA and RA patients

Interventions

The examinations for bones in joints of OA and RA patientsPROCEDURE
RA and OA

Eligibility Criteria

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

The patients who have OA with accompaying joint pain or the patients who have RA with accompaying joint pain

You may qualify if:

  • RA and/or OA

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yukio Nakamura

Matsumoto, Nagano, 3908621, Japan

RECRUITING

Yukio Nakamura

Matsumoto, Japan

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 21, 2014

First Posted

December 30, 2014

Study Start

November 1, 2015

Primary Completion

April 1, 2022

Study Completion

December 1, 2024

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

JP(2)