A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

A Phase 3 study testing T-614 in people with Rheumatoid Arthritis, run by Eisai Co., Ltd. at 72 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis Read more about this study

Who is it for?: Ages 20 to 69 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: T-614
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 253 participants
Where: 72 sitesJapan
Study dates: 31 Jul 2009to 30 Sep 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 69 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria
Age greater or 20 years and less than 70 years old

Who cannot join

Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant

Trial locations and contacts

72 sites in 1 country.

City, postcode or hospital

72 sites in 1 country

Japan72 sites

Study site
Amagasaki, Hyōgo
Study site
Anjo, Aichi-ken
Study site
Asahikawa, Hokkaido
Study site
Chitose, Hokkaido
Study site
Chiyoda City, Tokyo
Study site
Edogawa City, Tokyo
Study site
Fukuoka
Study site
Gifu
Study site
Hakodate, Hokkaido
Study site
Higashiosaka, Osaka
Study site
Hiki-gun, Saitama
Study site
Hirakata, Osaka
Study site
Hiroshima
Study site
Hitachi, Ibaraki
Study site
Hitachi-Naka, Ibaraki
Study site
Hōfu, Yamaguchi
Study site
Hyūga, Miyazaki
Study site
Ichikawa, Chiba
Study site
Ichinomiya, Aichi-ken
Study site
Ikoma, Nara
Study site
Iruma, Saitama
Study site
Isahaya, Nagasaki
Study site
Kagashima
Study site
Kagoshima
Study site
Kanazawa, Ishikawa-ken
Study site
Katō, Hyōgo
Study site
Kawaguchi, Saitama
Study site
Kawasaki, Kanagawa
Study site
Kirishima, Kagoshima-ken
Study site
Kitakyushu, Fukuoka
Study site
Kobe, Hyōgo
Study site
Kochi
Study site
Komatsu, Ishikawa-ken
Study site
Kumamoto
Study site
Kurume, Fukuoka
Study site
Kyoto
Study site
Maebashi, Gunma
Study site
Matsudo, Chiba
Study site
Matsue, Shimane
Study site
Miyagi-gun, Miyagi
Study site
Morioka, Iwate
Study site
Nagano
Study site
Nagasaki
Study site
Nagoya, Aichi-ken
Study site
Narita, Chiba
Study site
Nasushiobara, Tochigi
Study site
Ōita
Study site
Okazaki, Aichi-ken
Study site
Osaka
Study site
Otaku, Tokyo
Study site
Oyama, Tochigi
Study site
Saitama
Study site
Sapporo, Hokkaido
Study site
Sasebo, Nagasaki
Study site
Sendai, Miyagi
Study site
Setagaya City, Tokyo
Study site
Shimotsuke, Tochigi
Study site
Shizuoka
Study site
Sumida City, Tokyo
Study site
Takaoka, Toyama
Study site
Takasaki, Gunma
Study site
Takatsuki, Osaka
Study site
Tamana, Kumamoto
Study site
Tokorozawa, Saitama
Study site
Tokushima
Study site
Tomakomai, Hokkaido
Study site
Tonami, Toyama
Study site
Toyohashi, Aichi-ken
Study site
Tsukuba, Ibaraki
Study site
Yokohama, Kanagawa
Study site
Yonezawa, Yamagata
Study site
Yoshinogawa, Tokushima

Other trials in Japan

About this study

Conditions: Rheumatoid Arthritis
Being tested: T-614, Placebo
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T-614Drug
T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.
PlaceboDrug
Placebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.

Study groups in NCT00965757
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: T-614
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of American College of Rheumatology [ACR] 20 Criteria Responders
ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].
Measured: Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)

Secondary outcomes (8)

Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)
Measured: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Change From Baseline in PAP, PtGADA and PyGADA
Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0-100 mm, with higher scores indicating severe disease.
Measured: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.
Measured: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Change From Baseline in C-reactive Protein (CRP)
Assessment of individual ACR core components i.e. CRP
Measured: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Assessment of individual ACR core components i.e. ESR
Measured: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)
The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity).
Measured: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Percentage of ACR 50 Criteria Responders
ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].
Measured: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Percentage of ACR 70 Criteria Responders
ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].
Measured: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jul 200930 Sep 2011

First posted26 Aug 2009 (estimated)
Study start31 Jul 2009
Primary completion30 Sep 2011
Study completion30 Sep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 253 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00965757
Sponsor's protocol ID: T614-ADN
Status last verified: Nov 2015
First submitted: 25 Aug 2009
Last updated: 17 Dec 2021
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
ClinicalTrials.gov ID: NCT00965757
Acronym / sponsor ID: T614-ADN
Conditions: Rheumatoid Arthritis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 253 participants (actual)
Lead sponsor: Eisai Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: FUJIFILM Toyama Chemical Co., Ltd.
Study start: 31 Jul 2009 (actual)
Primary completion: 30 Sep 2011 (actual)
Study completion: 30 Sep 2011 (actual)
First posted: 26 Aug 2009 (estimated)
Results: Posted 19 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: T-614
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 20 to 69 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria
Age greater or 20 years and less than 70 years old

Key exclusion criteria (2 listed)

Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
Women of childbearing potential who are not practicing a successful method of contraception, or wish to become 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
T-614T-614 is administered twice daily in combination with methotrexate. The daily dose of T-614 is 25 mg for the first 4 weeks and 50 mg for subsequent weeks.	Drug	1
PlaceboPlacebo is administered twice daily in combination with methotrexate. In placebo group, patients will receive T-614 after completing 28 weeks of treatment.	Drug	2

Primary outcome

Percentage of American College of Rheumatology [ACR] 20 Criteria Responders
Time frame: Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)
ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant [erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)].

8 secondary outcomes

Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Change From Baseline in PAP, PtGADA and PyGADA
Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Change From Baseline in C-reactive Protein (CRP)
Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)
Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Percentage of ACR 50 Criteria Responders
Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)
Percentage of ACR 70 Criteria Responders
Time frame: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)

Results and safety

Results posted to the registry on 19 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T-614 (Double-blind, 1-28 Weeks)	165	148
Placebo (Double-blind, 1-28 Weeks)	88	70
T-614 (Extension, 29-52 Weeks)	0	0
Placebo/T-614 (Extension, 29-52 Weeks)	0	0

Primary outcome: Percentage of American College of Rheumatology [ACR] 20 Criteria Responders

Time frame: Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm). Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) n = 164	Placebo (Double-blind, 1-28 Weeks) n = 88	Placebo/T-614 (Extension, 29-52 Weeks) n = 68
Week 24 LOCF	69.5 (61.9 to 76.5)	30.7 (21.3 to 41.4)	NA (NA to NA)
Week 52 LOCF	71.3 (63.8 to 78.1)	NA (NA to NA)	72.1 (59.9 to 82.3)

Population analysed: Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)	2 of 164 (1.2%)	135 of 164 (82.3%)	Not reported
Placebo (Double-blind, 1-28 Weeks)	2 of 88 (2.3%)	43 of 88 (48.9%)	Not reported
Placebo/T-614 (Extension, 29-52 Weeks)	0 of 68 (0%)	41 of 68 (60.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

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.

Kota Nagai study director

JAC PCU. EPCS, Eisai Co., Ltd.

72 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing T-614 in people with Rheumatoid Arthritis, run by Eisai Co., Ltd. at 72 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 2 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: finished, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of American College of Rheumatology [ACR] 20 Criteria Responders (time frame: Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)). 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 NCT00965757.

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 Dec 2021; AzTrials last refreshed its copy on 2 Nov 2026.