Rheumatoid ArthritisPhase 2NCT03755466
Examination of Efficacy and Safety of Baricitinib in RA Patients
A Phase 2 study testing "Baricitinib", "olumiant®", "Biologics" and Tofacitinib 5 MG [Xeljanz] in people with Rheumatoid Arthritis, run by Shinshu University at 1 site in Japan.
Trial summary
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients: 1. Baricitinib treatment for 12 months 2. Biologics treatment for 12 months 3. Tofacitinib treatment for 12 months Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- "Baricitinib", "olumiant®", "Biologics" and Tofacitinib 5 MG [Xeljanz]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteJapan
- Study dates
- 21 Nov 2018to 20 Nov 2025
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA patients
Who cannot join
- Not RA patients
- RA patients who are allergic to the drugs, refused to do this research, or who are pregnant
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yukio Nakamura
Matsumoto, Nagano, 3908621
Yukio Nakamura, MD, PhD, +81-263-37-2659, yxn14@aol.jp
Yukio Nakamura, MD, PhD
About this study
Official title: Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:
- Baricitinib treatment for 12 months
- Biologics treatment for 12 months
- Tofacitinib treatment for 12 months
- Conditions
- Rheumatoid Arthritis
- Being tested
- "Baricitinib", "olumiant®", "Biologics", Tofacitinib 5 MG [Xeljanz]
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Baricitinib", "olumiant®"Drug
To examine the effects of baricitinib in RA patients
"Biologics"Drug
To examine the effects of biologics in RA patients
Tofacitinib 5 MG [Xeljanz]Drug
To examine the effects of tofacitinib in RA patients
| Study group | Role | What they receive |
|---|---|---|
| BARI | Active comparator | Not described Receives: Drug: "Biologics"; Drug: Tofacitinib 5 MG [Xeljanz] |
| Bio | Active comparator | Not described Receives: Drug: "Baricitinib", "olumiant®"; Drug: Tofacitinib 5 MG [Xeljanz] |
| Tofa | Active comparator | Not described Receives: Drug: "Baricitinib", "olumiant®"; Drug: "Biologics" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients.
Measured: Change from Baseline Values of DAS28-CRP at 1 year in each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start21 Nov 2018
- Primary completion20 Nov 2023 (estimated)
- Study completion20 Nov 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 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
- NCT03755466
- Sponsor's protocol ID
- BARI2018
- Status last verified
- Sep 2021
- First submitted
- 21 Nov 2018
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Efficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or Tofacitinib
- ClinicalTrials.gov ID
- NCT03755466
- Acronym / sponsor ID
- BARI2018
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shinshu UniversityUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 28 Nov 2018 (actual)
- 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.
The aim of this study is to examine the efficacy and adverse events in the following 3 groups in rheumatoid arthritis patients:
- Baricitinib treatment for 12 months
- Biologics treatment for 12 months
- Tofacitinib treatment for 12 months
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BARI | Active comparator | Drug: "Biologics", Drug: Tofacitinib 5 MG [Xeljanz] |
| Bio | Active comparator | Drug: "Baricitinib", "olumiant®", Drug: Tofacitinib 5 MG [Xeljanz] |
| Tofa | Active comparator | Drug: "Baricitinib", "olumiant®", Drug: "Biologics" |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- RA patients
Key exclusion criteria (2 listed)
- Not RA patients
- RA patients who are allergic to the drugs, refused to do this research, or who are pregnant
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 |
|---|---|---|
| "Baricitinib", "olumiant®"To examine the effects of baricitinib in RA patients | Drug | Bio, Tofa |
| "Biologics"To examine the effects of biologics in RA patients | Drug | BARI, Tofa |
| Tofacitinib 5 MG [Xeljanz]To examine the effects of tofacitinib in RA patients | Drug | BARI, Bio |
Primary outcome
Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients.
Time frame: Change from Baseline Values of DAS28-CRP at 1 year in each group
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.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Baricitinib", "olumiant®", "Biologics" and Tofacitinib 5 MG [Xeljanz] 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 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Assessment of Disease Activity in rheumatoid patients for 1 year treated by baricitinib (N=30), biologics (N=30), or tofacitinib (N=30). Also, the efficacy and adverse event of each drug for 1 year in the RA patients. (time frame: Change from Baseline Values of DAS28-CRP at 1 year in each group). 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.