NCT01080131 · OUTCOME
Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study. · Source last updated 2014-01-30
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
- 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
What was measured
The study physician assessed the most affected joint for tenderness on the following 4-point scale:
* no pain;
* participant states that "there is pain;
* participant states "there is pain and winces";
* participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
Analysis population: Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
Groups in this outcome
Re-treated With Canakinumab 150 mg
Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
Triam Switched to Canakinumab
Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Re-treated With Canakinumab 150 mg | 62 |
|---|
| Triam Switched to Canakinumab | 41 |
|---|
Reported measurements
72 hours - No pain [N=56, 38]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Re-treated With Canakinumab 150 mg | 51.8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triam Switched to Canakinumab | 42.1 | Not reported | Not reported | Not reported | Not reported |
|---|
72 hours - Pain [N=56, 38]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Re-treated With Canakinumab 150 mg | 37.5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triam Switched to Canakinumab | 50.0 | Not reported | Not reported | Not reported | Not reported |
|---|
72 hours - Pain and winces [N=56, 38]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Re-treated With Canakinumab 150 mg | 5.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triam Switched to Canakinumab | 5.3 | Not reported | Not reported | Not reported | Not reported |
|---|
72 hours - Pain, winces and withdraws [N=56, 38]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Re-treated With Canakinumab 150 mg | 5.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triam Switched to Canakinumab | 2.6 | Not reported | Not reported | Not reported | Not reported |
|---|
7 days - No pain [N=58, 39]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Re-treated With Canakinumab 150 mg | 74.1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triam Switched to Canakinumab | 79.5 | Not reported | Not reported | Not reported | Not reported |
|---|
7 days - Pain [N=58, 39]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Re-treated With Canakinumab 150 mg | 22.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triam Switched to Canakinumab | 20.5 | Not reported | Not reported | Not reported | Not reported |
|---|
7 days - Pain and winces [N=58, 39]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Re-treated With Canakinumab 150 mg | 3.4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triam Switched to Canakinumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
7 days - Pain, winces and withdraws [N=58, 39]
Values in percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Re-treated With Canakinumab 150 mg | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Triam Switched to Canakinumab | 0.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 51.8
- group Id
- OG001
- value
- 42.1
- title
- 72 hours - No pain [N=56, 38]
- categories
- measurements
- group Id
- OG000
- value
- 37.5
- group Id
- OG001
- value
- 50.0
- title
- 72 hours - Pain [N=56, 38]
- categories
- measurements
- group Id
- OG000
- value
- 5.4
- group Id
- OG001
- value
- 5.3
- title
- 72 hours - Pain and winces [N=56, 38]
- categories
- measurements
- group Id
- OG000
- value
- 5.4
- group Id
- OG001
- value
- 2.6
- title
- 72 hours - Pain, winces and withdraws [N=56, 38]
- categories
- measurements
- group Id
- OG000
- value
- 74.1
- group Id
- OG001
- value
- 79.5
- title
- 7 days - No pain [N=58, 39]
- categories
- measurements
- group Id
- OG000
- value
- 22.4
- group Id
- OG001
- value
- 20.5
- title
- 7 days - Pain [N=58, 39]
- categories
- measurements
- group Id
- OG000
- value
- 3.4
- group Id
- OG001
- value
- 0.0
- title
- 7 days - Pain and winces [N=58, 39]
- categories
- measurements
- group Id
- OG000
- value
- 0.0
- group Id
- OG001
- value
- 0.0
- title
- 7 days - Pain, winces and withdraws [N=58, 39]
- denoms
- counts
- group Id
- OG000
- value
- 62
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- The study physician assessed the most affected joint for tenderness on the following 4-point scale:
* no pain;
* participant states that "there is pain;
* participant states "there is pain and winces";
* participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.
Data are reported for the last post-baseline flare for participants who were randomized to and re-treated with canakinumab, and for the first post-baseline flare treated with canakinumab for participants randomized to triamcinolone acetonide and who were switched to canakinumab in extension study 2.
- groups
- description
- Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
- id
- OG000
- title
- Re-treated With Canakinumab 150 mg
- description
- Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
- id
- OG001
- title
- Triam Switched to Canakinumab
- param Type
- NUMBER
- population Description
- Modified Analysis Set (MAS) consisting of all FAS patients who were either re-treated or switched to canakinumab during the 72 weeks. At each timepoint only patients with a value at both baseline flare and the new flare are included.
- reporting Status
- POSTED
- time Frame
- 72 hours post-dose and 7 days post dose for the last post-baseline flare for the canakinumab re-treated arm and for the first post-baseline flare treated with canakinumab in the triamcinolone acetonide arm during the overall 72 weeks.
- title
- Physician's Assessment of Joint Tenderness for Participants Re-treated or Switched to Canakinumab
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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