TriangleNCT01185353 · OUTCOME
Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 76 and 128
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline through 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 VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores \<2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.
Analysis population: All participants who received study drug in Parts C and D and had DAS28-CRP evaluated at analysis time points.
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
Low Disease activity - Week 76 (n=108, 61, 32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | 58 | Not reported | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 38 | Not reported | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 44 | Not reported | Not reported | Not reported | Not reported |
Remission - Week 76 (n=108, 61, 32)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | 52 | Not reported | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 21 | Not reported | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 22 | Not reported | Not reported | Not reported | Not reported |
Low Disease activity - Week 128 (n=79, 47, 18)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | 59 | Not reported | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 36 | Not reported | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 56 | Not reported | Not reported | Not reported | Not reported |
Remission - Week 128 (n=79, 47, 18)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 4 mg LY3009104 QD - Parts C and D | 47 | Not reported | Not reported | Not reported | Not reported |
| 4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 26 | Not reported | Not reported | Not reported | Not reported |
| 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D | 39 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 44
- title
- Low Disease activity - Week 76 (n=108, 61, 32)
- categories
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 22
- title
- Remission - Week 76 (n=108, 61, 32)
- categories
- measurements
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 36
- group Id
- OG002
- value
- 56
- title
- Low Disease activity - Week 128 (n=79, 47, 18)
- categories
- measurements
- group Id
- OG000
- value
- 47
- group Id
- OG001
- value
- 26
- group Id
- OG002
- value
- 39
- title
- Remission - 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
- 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 VAS (patient's global VAS). Scores ranged from 1.0-9.4, where lower scores indicated less disease activity. DAS28 scores ≤3.2 are considered as low disease activity, and scores \<2.6 are considered as remission. Participants who discontinue before analysis time points are treated as non-responders.
- 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
- NUMBER
- population Description
- All participants who received study drug in Parts C and D and had DAS28-CRP evaluated at analysis time points.
- reporting Status
- POSTED
- time Frame
- Baseline through Weeks 76 and 128
- title
- Percentage of Participants Meeting Low Disease Activity and Remission Based on the 28 Diarthrodial Joint Count (DAS28) Baseline Through Weeks 76 and 128
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice