TriangleNCT01185353 · OUTCOME
Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- number of joints
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline, Weeks 12 and 24
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 randomized participants who received study drug in Parts A and B and had TJC and SJC evaluated at analysis time points. LOCF was used to impute missing post-baseline values
Groups in this outcome
1 mg LY3009104
1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
2 mg LY3009104
2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
4 mg LY3009104
4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
8 mg LY3009104
8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
Placebo
Placebo administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
| Group | Source count |
|---|---|
| 1 mg LY3009104 | 49 |
| 2 mg LY3009104 | 52 |
| 4 mg LY3009104 | 51 |
| 8 mg LY3009104 | 50 |
| Placebo | 98 |
Reported measurements
TJC - Week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1 mg LY3009104 | -8.4 | 12.70 | Not reported | Not reported | Not reported |
| 2 mg LY3009104 | -11.3 | 13.50 | Not reported | Not reported | Not reported |
| 4 mg LY3009104 | -12.2 | 10.45 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 | -14.7 | 12.97 | Not reported | Not reported | Not reported |
| Placebo | -7.6 | 12.31 | Not reported | Not reported | Not reported |
TJC - Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1 mg LY3009104 | NA | NA | Not reported | Not reported | Participants were not dosed with 1 mg LY3009104 after Week 12, therefore mean and standard deviation (SD) were not calculated. |
| 2 mg LY3009104 | -12.4 | 12.60 | Not reported | Not reported | Not reported |
| 4 mg LY3009104 | -14.0 | 9.54 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 | -17.5 | 11.23 | Not reported | Not reported | Not reported |
| Placebo | NA | NA | Not reported | Not reported | Participants were not dosed with placebo after Week 12, therefore mean and SD were not calculated. |
SJC - Week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1 mg LY3009104 | -8.1 | 7.24 | Not reported | Not reported | Not reported |
| 2 mg LY3009104 | -8.9 | 9.03 | Not reported | Not reported | Not reported |
| 4 mg LY3009104 | -9.6 | 6.49 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 | -10.4 | 8.88 | Not reported | Not reported | Not reported |
| Placebo | -6.7 | 7.97 | Not reported | Not reported | Not reported |
SJC - Week 24
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1 mg LY3009104 | NA | NA | Not reported | Not reported | Participants were not dosed with 1 mg LY3009104 after Week 12, therefore mean and SD were not calculated. |
| 2 mg LY3009104 | -10.0 | 8.16 | Not reported | Not reported | Not reported |
| 4 mg LY3009104 | -10.5 | 6.42 | Not reported | Not reported | Not reported |
| 8 mg LY3009104 | -12.2 | 7.29 | Not reported | Not reported | Not reported |
| Placebo | NA | NA | Not reported | Not reported | Participants were not dosed with placebo after Week 12, therefore mean and SD were not calculated. |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.480
- p Value Comment
- P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG001
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.064
- p Value Comment
- P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG002
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG003
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.001
- p Value Comment
- P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.116
- p Value Comment
- P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG001
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.201
- p Value Comment
- P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG002
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG003
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.002
- p Value Comment
- P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.480
- p Value Comment
- P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG001
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.064
- p Value Comment
- P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG002
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG003
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.001
- p Value Comment
- P-value is for TJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG000
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.116
- p Value Comment
- P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG001
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.201
- p Value Comment
- P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG002
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.001
- p Value Comment
- P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- ci Num Sides
- TWO_SIDED
- group Ids
- OG003
- OG004
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.002
- p Value Comment
- P-value is for SJC - Week 12. A priori p-value significance threshold: 2-sided ≤0.10.
- statistical Method
- ANCOVA
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.70
- value
- -8.4
- group Id
- OG001
- spread
- 13.50
- value
- -11.3
- group Id
- OG002
- spread
- 10.45
- value
- -12.2
- group Id
- OG003
- spread
- 12.97
- value
- -14.7
- group Id
- OG004
- spread
- 12.31
- value
- -7.6
- title
- TJC - Week 12
- categories
- measurements
- comment
- Participants were not dosed with 1 mg LY3009104 after Week 12, therefore mean and standard deviation (SD) were not calculated.
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 12.60
- value
- -12.4
- group Id
- OG002
- spread
- 9.54
- value
- -14.0
- group Id
- OG003
- spread
- 11.23
- value
- -17.5
- comment
- Participants were not dosed with placebo after Week 12, therefore mean and SD were not calculated.
- group Id
- OG004
- spread
- NA
- value
- NA
- title
- TJC - Week 24
- categories
- measurements
- group Id
- OG000
- spread
- 7.24
- value
- -8.1
- group Id
- OG001
- spread
- 9.03
- value
- -8.9
- group Id
- OG002
- spread
- 6.49
- value
- -9.6
- group Id
- OG003
- spread
- 8.88
- value
- -10.4
- group Id
- OG004
- spread
- 7.97
- value
- -6.7
- title
- SJC - Week 12
- categories
- measurements
- comment
- Participants were not dosed with 1 mg LY3009104 after Week 12, therefore mean and SD were not calculated.
- group Id
- OG000
- spread
- NA
- value
- NA
- group Id
- OG001
- spread
- 8.16
- value
- -10.0
- group Id
- OG002
- spread
- 6.42
- value
- -10.5
- group Id
- OG003
- spread
- 7.29
- value
- -12.2
- comment
- Participants were not dosed with placebo after Week 12, therefore mean and SD were not calculated.
- group Id
- OG004
- spread
- NA
- value
- NA
- title
- SJC - Week 24
- denoms
- counts
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 52
- group Id
- OG002
- value
- 51
- group Id
- OG003
- value
- 50
- group Id
- OG004
- value
- 98
- 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
- 1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
- id
- OG000
- title
- 1 mg LY3009104
- description
- 2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
- id
- OG001
- title
- 2 mg LY3009104
- description
- 4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
- id
- OG002
- title
- 4 mg LY3009104
- description
- 8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
- id
- OG003
- title
- 8 mg LY3009104
- description
- Placebo administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
- id
- OG004
- title
- Placebo
- param Type
- MEAN
- population Description
- All randomized participants who received study drug in Parts A and B 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 12 and 24
- title
- Mean Change From Baseline to Weeks 12 and 24 in Tender and Swollen Joint Counts (TJC and SJC)
- type
- SECONDARY
- unit Of Measure
- number of joints
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Preserved source evidence · Not medical advice