Trial · NCT00965757
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
NCT00965757, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2015-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00965757. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00965757
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT00965757
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 253 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Rheumatoid Arthritis
- Interventions
- T-614, Placebo
- First posted
- 2009-08-26
- Last updated
- 2021-12-17
- Results first posted
- 2015-06-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of American College of Rheumatology [ACR] 20 Criteria Responders | 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 \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\]. |
| Secondary | Change From Baseline in Tender Joint Counts and Swollen Joint Counts | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC) |
| Secondary | Change From Baseline in PAP, PtGADA and PyGADA | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | 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. |
| Secondary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | 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. |
| Secondary | Change From Baseline in C-reactive Protein (CRP) | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | Assessment of individual ACR core components i.e. CRP |
| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | Assessment of individual ACR core components i.e. ESR |
| Secondary | 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) | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | 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). |
| Secondary | Percentage of ACR 50 Criteria Responders | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | 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 \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\]. |
| Secondary | Percentage of ACR 70 Criteria Responders | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | 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 \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\]. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Change From Baseline in Tender Joint Counts and Swollen Joint Counts | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | FAS (Double-blind), Efficacy Analysis Set (Extension) | joint counts | MEAN |
| SECONDARY | Change From Baseline in PAP, PtGADA and PyGADA | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | FAS (Double-blind), Efficacy Analysis Set (Extension) | mm | MEAN |
| SECONDARY | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | FAS (Double-blind), Efficacy Analysis Set (Extension) | score on scale | MEAN |
| SECONDARY | Change From Baseline in C-reactive Protein (CRP) | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | FAS (Double-blind), Efficacy Analysis Set (Extension) | mg/dl | MEAN |
| SECONDARY | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | FAS (Double-blind), Efficacy Analysis Set (Extension) | mm/hr | MEAN |
| SECONDARY | 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) | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | FAS (Double-blind), Efficacy Analysis Set (Extension) | participants | NUMBER |
| SECONDARY | Percentage of ACR 50 Criteria Responders | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension) | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of ACR 70 Criteria Responders | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | FAS (Double-blind), Efficacy Analysis Set (Extension) | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of American College of Rheumatology [ACR] 20 Criteria Responders | 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) | Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension) | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group102
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | Baseline: TJC | 12.5 | Standard Deviation 6.5 | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | Placebo (Double-blind, 1-28 Weeks) | Baseline: TJC | 13.3 | Standard Deviation 8.1 | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | Placebo/T-614 (Extension, 29-52 Weeks) | Baseline: TJC | 13.8 | Standard Deviation 8.5 | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | Change from baseline at week 24 LOCF: TJC | -7.4 | Standard Deviation 6 | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | Placebo (Double-blind, 1-28 Weeks) | Change from baseline at week 24 LOCF: TJC | -4.6 | Standard Deviation 7.8 | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | Placebo/T-614 (Extension, 29-52 Weeks) | Change from baseline at week 24 LOCF: TJC | NA | Standard Deviation NA | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | Change from baseline at week 52 LOCF: TJC | -8.4 | Standard Deviation 6.1 | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | Placebo (Double-blind, 1-28 Weeks) | Change from baseline at week 52 LOCF: TJC | NA | Standard Deviation NA | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | Placebo/T-614 (Extension, 29-52 Weeks) | Change from baseline at week 52 LOCF: TJC | -9.9 | Standard Deviation 7.6 | joint counts |
| Change From Baseline in Tender Joint Counts and Swollen Joint Counts | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | Baseline: SJC | 11.5 | Standard Deviation 6.3 | joint counts |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase | STARTED | T-614 (Double-blind, 1-28 Weeks) | 165 | |
| Double-blind Phase | STARTED | Placebo (Double-blind, 1-28 Weeks) | 88 | |
| Double-blind Phase | STARTED | T-614 (Extension, 29-52 Weeks) | 0 | |
| Double-blind Phase | STARTED | Placebo/T-614 (Extension, 29-52 Weeks) | 0 | |
| Double-blind Phase | COMPLETED | T-614 (Double-blind, 1-28 Weeks) | 148 | |
| Double-blind Phase | COMPLETED | Placebo (Double-blind, 1-28 Weeks) | 70 | |
| Double-blind Phase | COMPLETED | T-614 (Extension, 29-52 Weeks) | 0 | |
| Double-blind Phase | COMPLETED | Placebo/T-614 (Extension, 29-52 Weeks) | 0 | |
| Double-blind Phase | NOT COMPLETED | T-614 (Double-blind, 1-28 Weeks) | 17 | |
| Double-blind Phase | NOT COMPLETED | Placebo (Double-blind, 1-28 Weeks) | 18 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events63
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | 52 | 164 | 71 |
| other | Nasopharyngitis | Infections and infestations | Placebo (Double-blind, 1-28 Weeks) | 14 | 88 | 18 |
| other | Nasopharyngitis | Infections and infestations | Placebo/T-614 (Extension, 29-52 Weeks) | 15 | 68 | 17 |
| other | Pharyngitis | Infections and infestations | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | 10 | 164 | 14 |
| other | Pharyngitis | Infections and infestations | Placebo (Double-blind, 1-28 Weeks) | 6 | 88 | 6 |
| other | Pharyngitis | Infections and infestations | Placebo/T-614 (Extension, 29-52 Weeks) | 0 | 68 | 0 |
| other | Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | 20 | 164 | 25 |
| other | Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Placebo (Double-blind, 1-28 Weeks) | 2 | 88 | 3 |
| other | Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Placebo/T-614 (Extension, 29-52 Weeks) | 4 | 68 | 4 |
| other | Stomatitis | Gastrointestinal disorders | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | 18 | 164 | 26 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | ||
| Total, all-cause mortality | Placebo (Double-blind, 1-28 Weeks) | ||
| Total, all-cause mortality | Placebo/T-614 (Extension, 29-52 Weeks) | ||
| Total, other adverse events | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | 135 | 164 |
| Total, other adverse events | Placebo (Double-blind, 1-28 Weeks) | 43 | 88 |
| Total, other adverse events | Placebo/T-614 (Extension, 29-52 Weeks) | 41 | 68 |
| Total, serious adverse events | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | 2 | 164 |
| Total, serious adverse events | Placebo (Double-blind, 1-28 Weeks) | 2 | 88 |
| Total, serious adverse events | Placebo/T-614 (Extension, 29-52 Weeks) | 0 | 68 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00965757
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