Progression of Rheumatoid ArthritisNCT02327650
To Examine Whether or Not the Primary Causes of OA or RA Might be Bone Alterations
An observational study of Progression of Rheumatoid Arthritis and Osteoarthritis of Multiple Joints, run by Shinshu University at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Progression of Rheumatoid Arthritis, Osteoarthritis of Multiple Joints
- What is being tested?
- The examinations for bones in joints of OA and RA patients
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesJapan
- Study dates
- Nov 2015to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The patients who have OA with accompaying joint pain or the patients who have RA with accompaying joint pain
Who may be able to join
- RA and/or OA
Who cannot join
- N/A
Trial locations and contacts
2 sites in 1 country.
Japan2 sites, 2 recruiting
- Recruiting
Yukio Nakamura
Matsumoto, Nagano, 3908621
Yukio Nakamura, MD, PhD, +81-263-37-2659, yxn14@aol.jp
Yukio Nakamura, MD, PhD
- Recruiting
Yukio Nakamura
Matsumoto
Yukio Nakamura, yxn14@aol.jp
About this study
Official title: The Examinations Whether or Not the Primary Causes of Osteoarthritis or Rheumatoid Arthritis in Joints Might be Bone Alterations
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.
- Being tested
- The examinations for bones in joints of OA and RA patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The examinations for bones in joints of OA and RA patientsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| RA and OA | Every 2 or 3 months, plain radiograph, blood and urinary tests, and MRI are performed in the painful joints of RA. Receives: Procedure: The examinations for bones in joints of OA and RA patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
The bone signal changes detected by MRI in OA and/or RA patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startNov 2015
- Primary completionApr 2022 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progression of Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukio Nakamura, Shinshu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327650
- Sponsor's protocol ID
- OA RA Bone Study
- Status last verified
- Sep 2021
- First submitted
- 21 Dec 2014
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Examinations Whether or Not the Primary Causes of Osteoarthritis or Rheumatoid Arthritis in Joints Might be Bone Alterations
- ClinicalTrials.gov ID
- NCT02327650
- Acronym / sponsor ID
- OA RA Bone Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA and OA | – | Procedure: The examinations for bones in joints of OA and RA patientsEvery 2 or 3 months, plain radiograph, blood and urinary tests, and MRI are performed in the painful joints of RA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who have OA with accompaying joint pain or the patients who have RA with accompaying joint pain
Key inclusion criteria (1 listed)
- RA and/or OA
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The examinations for bones in joints of OA and RA patients | Procedure or surgery | RA and OA |
Primary outcome
The bone signal changes detected by MRI in OA and/or RA patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progression of Rheumatoid Arthritis and Osteoarthritis of Multiple Joints, run by Shinshu University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The bone signal changes detected by MRI in OA and/or RA patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.