| Secondary | 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) | FAS (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Mean | Standard Deviation | joint counts | | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. | | OG002 | Placebo/T-614 (Extension, 29-52 Weeks) | Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily). |
| | | Title | Denominators | Categories |
|---|
| Baseline: TJC | | | Title | Measurements |
|---|
| - OG00012.5± 6.5
- OG00113.3± 8.1
- OG00213.8± 8.5
|
| | Change from baseline at week 24 LOCF: TJC |
| |
| Secondary | 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. | FAS (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Mean | Standard Deviation | mm | | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. | | OG002 | Placebo/T-614 (Extension, 29-52 Weeks) | |
|
| Secondary | 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. | FAS (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Mean | Standard Deviation | score on scale | | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. | | OG002 | Placebo/T-614 (Extension, 29-52 Weeks) | |
|
| Secondary | Change From Baseline in C-reactive Protein (CRP) | Assessment of individual ACR core components i.e. CRP | FAS (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Mean | Standard Deviation | mg/dl | | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. | | OG002 | Placebo/T-614 (Extension, 29-52 Weeks) | Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily). |
|
| Secondary | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Assessment of individual ACR core components i.e. ESR | FAS (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Mean | Standard Deviation | mm/hr | | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. | | OG002 | Placebo/T-614 (Extension, 29-52 Weeks) | Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily). |
|
| 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) | 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). | FAS (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Number | | participants | | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. |
|
| Secondary | 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)]. | Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. | |
|
| Secondary | 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)]. | FAS (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. | |
|
| Primary | 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)]. | Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension) | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 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) | | | | ID | Title | Description |
|---|
| OG000 | T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks) | T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks. | | OG001 | Placebo (Double-blind, 1-28 Weeks) | Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period. |
|