NCT00720798 · OUTCOME
Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264
An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies · Source last updated 2014-09-30
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
- Baseline to Week 264
What was measured
A DAS-28 responder was defined as someone who met the European League Against Rheumatism \[EULAR\] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.
Analysis population: All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
Groups in this outcome
Tocilizumab
Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
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 |
|---|
| Tocilizumab | 2067 |
|---|
Reported measurements
Week 24 Good (n = 1920)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 43.3 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 48 Good (n = 1753)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 51.9 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 108 Good (n = 1525)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 61.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 156 Good (n = 1441)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 64.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 204 Good (n = 1358)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 67.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 264 Good (n = 1278)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 68.8 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 24 Moderate (n = 1920)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 45.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 48 Moderate (n = 1753)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 40.0 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 108 Moderate (n = 1525)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 33.2 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 156 Moderate (n = 1441)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 28.7 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 204 Moderate (n = 1358)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 26.4 | Not reported | Not reported | Not reported | Not reported |
|---|
Week 264 Moderate (n = 1278)
Values in Percentage of participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tocilizumab | 26.1 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- Week 24 Good (n = 1920)
- title
- Week 48 Good (n = 1753)
- title
- Week 108 Good (n = 1525)
- title
- Week 156 Good (n = 1441)
- title
- Week 204 Good (n = 1358)
- title
- Week 264 Good (n = 1278)
- title
- Week 24 Moderate (n = 1920)
- title
- Week 48 Moderate (n = 1753)
- title
- Week 108 Moderate (n = 1525)
- title
- Week 156 Moderate (n = 1441)
- title
- Week 204 Moderate (n = 1358)
- title
- Week 264 Moderate (n = 1278)
- description
- A DAS-28 responder was defined as someone who met the European League Against Rheumatism \[EULAR\] criteria of a good or moderate response. A change of the DAS-28 score from Baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of \< -1.2 was a good response, \< -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score \> 3.2 to ≤ 5.1, a change from baseline of \< -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score \> 5.1, a change from baseline \< -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores \> 3.2.
- groups
- description
- Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.
- id
- OG000
- title
- Tocilizumab
- param Type
- NUMBER
- population Description
- All-exposure population: All participants who entered this study and received at least 1 dose of tocilizumab in either this extension study or in a core study. Only participants with available data were included in the analysis.
- time Frame
- Baseline to Week 264
- title
- Percentage of Participants Who Were Disease Activity Score 28 (DAS-28) Responders at Weeks 24, 48, 108, 156, 204, and 264
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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