TriangleNCT01185353 · OUTCOME
Mean Change From Baseline to Weeks 76 and 128 in TJC and SJC
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
TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
Analysis population: All participants who received study drug in Parts C and D and had TJC and SJC 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
TJC - Week 76 (n=108, 61, 32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -15.7 | 11.26 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -16.0 | 13.37 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -18.1 | 12.06 | Not reported | Not reported | Not reported |
TJC - Week 128 (n=79, 47, 18)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -16.4 | 11.01 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -15.3 | 12.56 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -14.0 | 13.68 | Not reported | Not reported | Not reported |
SJC - Week 76 (n=108, 61, 32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -11.6 | 6.40 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -12.9 | 7.80 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -12.4 | 7.67 | Not reported | Not reported | Not reported |
SJC - Week 128 (n=79, 47, 18)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | -11.4 | 6.81 | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -12.4 | 8.01 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | -11.6 | 6.23 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.26
- value
- -15.7
- group Id
- OG001
- spread
- 13.37
- value
- -16.0
- group Id
- OG002
- spread
- 12.06
- value
- -18.1
- title
- TJC - Week 76 (n=108, 61, 32)
- categories
- measurements
- group Id
- OG000
- spread
- 11.01
- value
- -16.4
- group Id
- OG001
- spread
- 12.56
- value
- -15.3
- group Id
- OG002
- spread
- 13.68
- value
- -14.0
- title
- TJC - Week 128 (n=79, 47, 18)
- categories
- measurements
- group Id
- OG000
- spread
- 6.40
- value
- -11.6
- group Id
- OG001
- spread
- 7.80
- value
- -12.9
- group Id
- OG002
- spread
- 7.67
- value
- -12.4
- title
- SJC - Week 76 (n=108, 61, 32)
- categories
- measurements
- group Id
- OG000
- spread
- 6.81
- value
- -11.4
- group Id
- OG001
- spread
- 8.01
- value
- -12.4
- group Id
- OG002
- spread
- 6.23
- value
- -11.6
- title
- SJC - 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
- TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint.
- 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 TJC and SJC 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 TJC and SJC
- type
- SECONDARY
- unit Of Measure
- units on a scale
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Preserved source evidence · Not medical advice