TriangleNCT01185353 · OUTCOME
Mean Change From Baseline to Weeks 76 and 128 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Weeks 76 and 128
What was measured
Physician's and Patient's assessments of DA assessed using a VAS that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).
Analysis population: All participants who received study drug in Parts C and D and had physician's and participant's assessments of disease activity and pain evaluated at analysis time points. LOCF was used to impute missing post-baseline values.
Groups in this outcome
4 mg LY3009104 QD - Parts C and D
Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A. Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B. Received 4 mg LY3009104 QD in Part C. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A. Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B. Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C. Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
Received 8 mg LY3009104 QD in Parts A, B and C. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
| Group | Source count |
|---|---|
| 4 mg LY3009104 QD - Parts C and D | 108 |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 61 |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 32 |
Reported measurements
Physician Assessment of DA-Week 76 (n=108, 61, 32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -40.3 | 19.15 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -32.3 | 23.37 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -40.5 | 21.44 | Not reported | Not reported | Not reported |
Physician Assessment of DA-Week 128 (n=79, 47, 18)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -39.5 | 20.32 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -31.0 | 25.54 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -34.0 | 27.51 | Not reported | Not reported | Not reported |
Patient Assessment of DA-Week 76 (n=108, 61, 32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -27.5 | 26.49 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -27.5 | 25.52 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -27.6 | 24.11 | Not reported | Not reported | Not reported |
Patient Assessment of DA-Week 128 (n=79, 47, 18)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -27.9 | 27.40 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -19.3 | 29.72 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -27.6 | 25.17 | Not reported | Not reported | Not reported |
Patient Assessment of Pain-Week 76 (n=108, 61, 32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -25.1 | 24.10 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -27.3 | 24.24 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -23.4 | 23.49 | Not reported | Not reported | Not reported |
Patient Assessment of Pain-Week 128 (n=79, 47, 18)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -24.2 | 24.35 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -18.0 | 28.85 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -22.3 | 22.99 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 19.15
- value
- -40.3
- group Id
- OG001
- spread
- 23.37
- value
- -32.3
- group Id
- OG002
- spread
- 21.44
- value
- -40.5
- title
- Physician Assessment of DA-Week 76 (n=108, 61, 32)
- categories
- measurements
- group Id
- OG000
- spread
- 20.32
- value
- -39.5
- group Id
- OG001
- spread
- 25.54
- value
- -31.0
- group Id
- OG002
- spread
- 27.51
- value
- -34.0
- title
- Physician Assessment of DA-Week 128 (n=79, 47, 18)
- categories
- measurements
- group Id
- OG000
- spread
- 26.49
- value
- -27.5
- group Id
- OG001
- spread
- 25.52
- value
- -27.5
- group Id
- OG002
- spread
- 24.11
- value
- -27.6
- title
- Patient Assessment of DA-Week 76 (n=108, 61, 32)
- categories
- measurements
- group Id
- OG000
- spread
- 27.40
- value
- -27.9
- group Id
- OG001
- spread
- 29.72
- value
- -19.3
- group Id
- OG002
- spread
- 25.17
- value
- -27.6
- title
- Patient Assessment of DA-Week 128 (n=79, 47, 18)
- categories
- measurements
- group Id
- OG000
- spread
- 24.10
- value
- -25.1
- group Id
- OG001
- spread
- 24.24
- value
- -27.3
- group Id
- OG002
- spread
- 23.49
- value
- -23.4
- title
- Patient Assessment of Pain-Week 76 (n=108, 61, 32)
- categories
- measurements
- group Id
- OG000
- spread
- 24.35
- value
- -24.2
- group Id
- OG001
- spread
- 28.85
- value
- -18.0
- group Id
- OG002
- spread
- 22.99
- value
- -22.3
- title
- Patient Assessment of Pain-Week 128 (n=79, 47, 18)
- denoms
- counts
- group Id
- OG000
- value
- 108
- group Id
- OG001
- value
- 61
- group Id
- OG002
- value
- 32
- units
- Participants
- description
- Physician's and Patient's assessments of DA assessed using a VAS that ranged from 0 to 100 mm, where 0 indicated no arthritis activity and 100 indicated extremely active arthritis. Patient's assessment of pain due to arthritis assessed using a VAS that ranged from 0 (no pain) to 100 mm (worst possible pain).
- dispersion Type
- Standard Deviation
- groups
- description
- Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A. Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B. Received 4 mg LY3009104 QD in Part C. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
- id
- OG000
- title
- 4 mg LY3009104 QD - Parts C and D
- description
- Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A. Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B. Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C. Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
- id
- OG001
- title
- 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
- description
- Received 8 mg LY3009104 QD in Parts A, B and C. Received 4 mg LY3009104 QD in Part D. MTX was administered orally as background therapy.
- id
- OG002
- title
- 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D
- param Type
- MEAN
- population Description
- All participants who received study drug in Parts C and D and had physician's and participant's assessments of disease activity and pain evaluated at analysis time points. LOCF was used to impute missing post-baseline values.
- reporting Status
- POSTED
- time Frame
- Baseline, Weeks 76 and 128
- title
- Mean Change From Baseline to Weeks 76 and 128 in Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity and Patient's Assessment of Pain
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice