Rheumatoid ArthritisPhase 4NCT02157012
Evaluation of the Condition of Rheumatoid Arthritis After Treatment
A Phase 4 study testing The effectiveness of Xeljanz in rheumatoid arthritis patients in people with Rheumatoid Arthritis, run by Shinshu University at 1 site in Japan.
Trial summary
To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- The effectiveness of Xeljanz in rheumatoid arthritis patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- May 2014to Mar 2025
- Phase
- Phase 4
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Rheumatoid arthritis
Who cannot join
- Other connective tissue disease
Trial locations and contacts
1 site in 1 country.
Yukio Nakamura, MD, PhD contact
Japan1 site, 1 recruiting
- Recruiting
Yukio Nakamura
Matsumoto, Nagano, 3908621
Yukio Nakamura, MD, PhD, yxn14@aol.jp
About this study
Official title: Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients
To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients
- Conditions
- Rheumatoid Arthritis
- Being tested
- The effectiveness of Xeljanz in rheumatoid arthritis patients
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effectiveness of Xeljanz in rheumatoid arthritis patientsDrug
| Study group | Role | What they receive |
|---|---|---|
| The condition of rheumatoid arthritis | Experimental | Not described Receives: Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of clinical evaluation in rheumatoid arthritis
DAS28, SDAI, Blood testing, Plain radiograph, and Ultrasound will be performed.
Measured: Every month
Secondary outcomes (1)
Number of participants with adverse events
Measured: Every month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionApr 2022 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shinshu University
- Sponsor type
- University, hospital or other
- Collaborators
- Showa Inan General Hospital
- Responsible party
- Principal investigator, Yukio Nakamura, Shinshu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157012
- Sponsor's protocol ID
- Xeljanz2014
- Status last verified
- Sep 2021
- First submitted
- 1 Jun 2014
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
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
- Evaluation of the Condition After Xeljanz Treatment in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT02157012
- Acronym / sponsor ID
- Xeljanz2014
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Collaborators
- Showa Inan General Hospital
- Study start
- May 2014 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 5 Jun 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.
To examine the safety and effectiveness after Xeljanz treatment in rheumatoid arthritis patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The condition of rheumatoid arthritis | Experimental | Drug: The effectiveness of Xeljanz in rheumatoid arthritis patients |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatoid arthritis
Key exclusion criteria (1 listed)
- Other connective tissue disease
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 effectiveness of Xeljanz in rheumatoid arthritis patients | Drug | The condition of rheumatoid arthritis |
Primary outcome
Change from baseline of clinical evaluation in rheumatoid arthritis
Time frame: Every month
DAS28, SDAI, Blood testing, Plain radiograph, and Ultrasound will be performed.
1 secondary outcome
Number of participants with adverse events
Time frame: Every month
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.
Yukio Nakamura, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing The effectiveness of Xeljanz in rheumatoid arthritis patients in people with Rheumatoid Arthritis, run by Shinshu University at 1 site 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 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yukio Nakamura, MD, PhD (yxn14@aol.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of clinical evaluation in rheumatoid arthritis (time frame: Every month). 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.