TriangleNCT01185353 · OUTCOME
Mean Change From Baseline to Weeks 76 and 128 in hsCRP
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- mg/L
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Weeks 76 and 128
What was measured
hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.
Analysis population: All participants who received study drug in Parts C and D and had hsCRP 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
Week 76 (n=108, 61, 32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -3.9 | 22.43 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -3.3 | 14.28 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -2.9 | 25.36 | 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 | -6.8 | 13.66 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -2.9 | 21.88 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -8.2 | 12.33 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 22.43
- value
- -3.9
- group Id
- OG001
- spread
- 14.28
- value
- -3.3
- group Id
- OG002
- spread
- 25.36
- value
- -2.9
- title
- Week 76 (n=108, 61, 32)
- categories
- measurements
- group Id
- OG000
- spread
- 13.66
- value
- -6.8
- group Id
- OG001
- spread
- 21.88
- value
- -2.9
- group Id
- OG002
- spread
- 12.33
- value
- -8.2
- title
- 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
- hsCRP is a laboratory analyte that is an indicator of inflammation. Decreases in hsCRP represent reductions in inflammation.
- 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 hsCRP 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 hsCRP
- type
- SECONDARY
- unit Of Measure
- mg/L
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice