Rheumatoid ArthritisPhase 2NCT03605251
Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.
A Phase 2 study testing TAS5315 low dose and TAS5315 high dose in people with Rheumatoid Arthritis, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- TAS5315 low dose and TAS5315 high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteJapan
- Study dates
- 30 Aug 2018to 28 May 2020
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria
- Have been treated with methotrexate (MTX) for at least 90 days prior to screening, and must be on a stable dose between 8 and 16 mg/week for at least 56 days prior to screening.
- Have an inadequate response to MTX
- Have a minimum of 6 swollen and 6 tender joints from 66/68 joint count
- Have hsCRP of ≥ 0.6 mg/dL
Who cannot join
- Have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for MTX, within 28 days prior to randomization
- Have an inadequate response to biologic disease-modifying anti-rheumatic drug or Have been treated with 2 biologic treatment
- Have been treated with Janus Kinase inhibitors or other Bruton's Tyrosine Kinase inhibitors
- Have a positive result for hepatitis B surface antigen/antibody, hepatitis B core antibody, hepatitis C virus antibody or human immunodeficiency virus antigen/antibody at screening
- Have been treated with Oral steroids at dose above 10 mg/day of prednisone or prednisone equivalents
- Have a diagnosis of Felty's syndrome
- Have a positive result of the QuantiFERON®-tuberculosis (TB) Gold test or a T-spot ®-TB test at screening
- Have a positive result of β-D-glucan at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.
- Conditions
- Rheumatoid Arthritis
- Being tested
- TAS5315 low dose, TAS5315 high dose, Placebos
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS5315 low doseDrug
Oral administration for 12 or 36 weeks
TAS5315 high doseDrug
Oral administration for 12 or 36 weeks
PlacebosDrug
Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)
| Study group | Role | What they receive |
|---|---|---|
| TAS5315 low dose group | Experimental | TAS5315 low dose and Methotrexate as specified Receives: Drug: TAS5315 low dose |
| TAS5315 high dose group | Experimental | TAS5315 high dose and Methotrexate as specified Receives: Drug: TAS5315 high dose |
| Placebo group | Placebo comparator | Placebo and Methotrexate as specified Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving American College of Rheumatology 20% (ACR20) response
Measured: Week 12
Secondary outcomes (16)
Proportion of participants who achieve ACR20 response
Measured: Up to Week 36, except for Week 12
Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response
Measured: Up to Week 36
Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission
Measured: Baseline, Week 12
Change from baseline in DAS28-CRP and DAS28-ESR score
Measured: Up to Week 36
Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission
Measured: Baseline, Week 12
Change from baseline in CDAI and SDAI score
Measured: Up to Week 36
Change from baseline in patient assessment score of arthritis pain
Measured: Up to Week 36
Change from baseline in patient global assessment score of arthritis
Measured: Up to Week 36
Change from baseline in physician's global assessment score of arthritis
Measured: Up to Week 36
Change from baseline in modified total sharp score
Measured: Baseline, Week 2, 4, 12
Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels
Measured: Up to Week 36
Change from baseline in rheumatoid factor levels
Measured: Up to Week 36
Maximum observed plasma concentration for TAS5315
Measured: Baseline, Week 2, 4, 12
Time to reach the maximum plasma concentration for TAS5315
Measured: Baseline, Week 2, 4, 12
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315
Measured: Baseline, Week 2, 4, 12
Incidence of adverse events and side effects as safety
Measured: Up to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start30 Aug 2018
- Primary completion30 Nov 2019
- Study completion28 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taiho Pharmaceutical Co., Ltd., Study director, Taiho Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605251
- Sponsor's protocol ID
- 10063030
- Status last verified
- Aug 2020
- First submitted
- 3 Jul 2018
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Takeuchi T, Tanaka S, Murata M, Tanaka Y. Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial. Ann Rheum Dis. 2023 Aug;82(8):1025-1034. doi: 10.1136/ard-2022-223759. Epub 2023 May 22.
PubMed 37217273
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
- ClinicalTrials.gov ID
- NCT03605251
- Acronym / sponsor ID
- 10063030
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 30 Jul 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 purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAS5315 low dose group | Experimental | Drug: TAS5315 low doseTAS5315 low dose and Methotrexate as specified |
| TAS5315 high dose group | Experimental | Drug: TAS5315 high doseTAS5315 high dose and Methotrexate as specified |
| Placebo group | Placebo comparator | Drug: PlacebosPlacebo and Methotrexate as specified |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria
- Have been treated with methotrexate (MTX) for at least 90 days prior to screening, and must be on a stable dose between 8 and 16 mg/week for at least 56 days prior to screening.
- Have an inadequate response to MTX
- Have a minimum of 6 swollen and 6 tender joints from 66/68 joint count
- Have hsCRP of ≥ 0.6 mg/dL
Key exclusion criteria (8 listed)
- Have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for MTX, within 28 days prior to randomization
- Have an inadequate response to biologic disease-modifying anti-rheumatic drug or Have been treated with 2 biologic treatment
- Have been treated with Janus Kinase inhibitors or other Bruton's Tyrosine Kinase inhibitors
- Have a positive result for hepatitis B surface antigen/antibody, hepatitis B core antibody, hepatitis C virus antibody or human immunodeficiency virus antigen/antibody at screening
- Have been treated with Oral steroids at dose above 10 mg/day of prednisone or prednisone equivalents
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 |
|---|---|---|
| TAS5315 low doseOral administration for 12 or 36 weeks | Drug | TAS5315 low dose group |
| TAS5315 high doseOral administration for 12 or 36 weeks | Drug | TAS5315 high dose group |
| PlacebosOral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group) | Drug | Placebo group |
Primary outcome
Proportion of participants achieving American College of Rheumatology 20% (ACR20) response
Time frame: Week 12
16 secondary outcomes
Proportion of participants who achieve ACR20 response
Time frame: Up to Week 36, except for Week 12
Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response
Time frame: Up to Week 36
Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission
Time frame: Baseline, Week 12
Change from baseline in DAS28-CRP and DAS28-ESR score
Time frame: Up to Week 36
Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission
Time frame: Baseline, Week 12
Change from baseline in CDAI and SDAI score
Time frame: Up to Week 36
Change from baseline in patient assessment score of arthritis pain
Time frame: Up to Week 36
Change from baseline in patient global assessment score of arthritis
Time frame: Up to Week 36
Change from baseline in physician's global assessment score of arthritis
Time frame: Up to Week 36
Change from baseline in modified total sharp score
Time frame: Baseline, Week 2, 4, 12
Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels
Time frame: Up to Week 36
Change from baseline in rheumatoid factor levels
Time frame: Up to Week 36
Maximum observed plasma concentration for TAS5315
Time frame: Baseline, Week 2, 4, 12
Time to reach the maximum plasma concentration for TAS5315
Time frame: Baseline, Week 2, 4, 12
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315
Time frame: Baseline, Week 2, 4, 12
Incidence of adverse events and side effects as safety
Time frame: Up to Week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Derived from this study: PubMed 37217273Takeuchi T, Tanaka S, Murata M, Tanaka Y. Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial. Ann Rheum Dis. 2023 Aug;82(8):1025-1034. doi: 10.1136/ard-2022-223759. Epub 2023 May 22.
- Individual participant dataSharing planned: Undecided
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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.
Taiho Pharmaceutical Co., Ltd. study director
Taiho Pharmaceutical Co., Ltd.
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 TAS5315 low dose and TAS5315 high dose in people with Rheumatoid Arthritis, run by Taiho Pharmaceutical Co., Ltd. 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 17 Aug 2020. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving American College of Rheumatology 20% (ACR20) response (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03605251, which also lists 1 linked publication.
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 17 Aug 2020.