TriangleNCT01185353 · OUTCOME
Mean Change From Baseline to Weeks 76 and 128 in DAS28-CRP
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
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
Analysis population: All participants who received study drug in Parts C and D and had DAS28-CRP 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 | 107 |
| 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 | 31 |
Reported measurements
Week 76 (n=107, 61, 31)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -2.47 | 1.23 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -2.16 | 1.28 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -2.68 | 1.12 | Not reported | Not reported | Not reported |
Week 128 (n=79, 47, 18)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -2.56 | 1.16 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -2.02 | 1.23 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -2.35 | 1.40 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.23
- value
- -2.47
- group Id
- OG001
- spread
- 1.28
- value
- -2.16
- group Id
- OG002
- spread
- 1.12
- value
- -2.68
- title
- Week 76 (n=107, 61, 31)
- categories
- measurements
- group Id
- OG000
- spread
- 1.16
- value
- -2.56
- group Id
- OG001
- spread
- 1.23
- value
- -2.02
- group Id
- OG002
- spread
- 1.40
- value
- -2.35
- title
- Week 128 (n=79, 47, 18)
- denoms
- counts
- group Id
- OG000
- value
- 107
- group Id
- OG001
- value
- 61
- group Id
- OG002
- value
- 31
- units
- Participants
- description
- Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), CRP (mg/L), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (patient's global VAS). DAS28-CRP=0.56\*square root (sqrt)(TJC28)+0.28\*sqrt(SJC28)+0.36\*natural log(CRP+1)+0.014\*patient's global VAS+0.96. Scores ranged from 1.0-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP \<2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.
- 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 DAS28-CRP 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 DAS28-CRP
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice