Trial Outcomes & Findings for An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (NCT NCT01669902)
NCT ID: NCT01669902
Last Updated: 2015-11-23
Results Overview
COMPLETED
107 participants
Month 6
2015-11-23
Participant Flow
Participant milestones
| Measure |
Tocilizumab
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Overall Study
STARTED
|
107
|
|
Overall Study
COMPLETED
|
78
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Overall Study
Adverse Event
|
11
|
|
Overall Study
Lack of Efficacy
|
10
|
|
Overall Study
Other
|
8
|
Baseline Characteristics
An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=107 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Age, Continuous
|
56.6 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: Safety Analysis Set
Outcome measures
| Measure |
Tocilizumab
n=107 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
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|---|---|
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Percentage of Participants on Tocilizumab Treatment at Month 6
|
76.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Safety Analysis Set
Dose modification is any change in dose; this also included participants who stopped treatment with tocilizumab.
Outcome measures
| Measure |
Tocilizumab
n=107 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants With Dose Modifications of Tocilizumab
|
36.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The Full Analysis Set (FAS) (swollen joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for swollen joints. n = participants evaluable for this measure at specified timepoint.
Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of swollen joints compared to baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=83 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
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|---|---|
|
Swollen Joint Count (SJC)
Baseline (n=83)
|
5.6 swollen joint count
Standard Deviation 5.2
|
|
Swollen Joint Count (SJC)
Month 3 (n=73)
|
2.5 swollen joint count
Standard Deviation 3.1
|
|
Swollen Joint Count (SJC)
Month 6 (n=63)
|
1.8 swollen joint count
Standard Deviation 2.5
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SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The FAS (tender joint counts) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for tender joints. n = participants evaluable for this measure at specified timepoint.
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28. A reduction in number of tender joints compared to baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=83 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Tender Joint Count (TJC)
Baseline (n=83)
|
8.6 tender joint count
Standard Deviation 6.9
|
|
Tender Joint Count (TJC)
Month 3 (n=73)
|
4.5 tender joint count
Standard Deviation 5.3
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|
Tender Joint Count (TJC)
Month 6 (n=63)
|
3.7 tender joint count
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The FAS (DAS28-4 \[CRP\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 \[CRP\] assessment. n = participants evaluable for this measure at specified timepoint.
DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (milligram per liter \[mg/L\]) and patient global assessment (PtGA) of disease activity (measured on a 0 to 100 millimeter \[mm\] Visual Analog Scale \[VAS\]) where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) less than or equal to (\<= 3.2) implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) less than (\<) 2.6 = clinical remission.
Outcome measures
| Measure |
Tocilizumab
n=83 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Baseline (n=83)
|
4.76 Units on a scale
Standard Deviation 1.31
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Month 3 (n=69)
|
3.17 Units on a scale
Standard Deviation 1.34
|
|
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Month 6 (n=60)
|
2.98 Units on a scale
Standard Deviation 1.21
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SECONDARY outcome
Timeframe: Month 3 and Month 6Population: FAS (DAS28-4 \[CRP\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.
DAS28-4 (CRP) was calculated from the SJC and TJC using the 28 joints count, CRP (mg/L) and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (CRP) was calculated using the following formula: DAS28-4 (CRP) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(CRP+1) + 0.014\*PtGA + 0.96. Total score range: 0 to 10, higher score indicated more disease activity. DAS28-4 (CRP) \<= 3.2 implied low disease activity and \> 3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (CRP) \< 2.6 = clinical remission.
Outcome measures
| Measure |
Tocilizumab
n=69 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)
Month 3 (n=69): Clinical remission
|
36.2 percentage of participants
|
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Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP)
Month 6 (n=60): Clinical remission
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The FAS (DAS28-4 \[ESR\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for DAS28-4 \[ESR\] assessment. n = participants evaluable for this measure at specified timepoint.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeter per hour \[mm/hour\]), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = clinical remission.
Outcome measures
| Measure |
Tocilizumab
n=59 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Baseline (n=59)
|
5.03 Units on a scale
Standard Deviation 1.39
|
|
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Month 3 (n=49)
|
2.98 Units on a scale
Standard Deviation 1.41
|
|
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Month 6 (n=45)
|
2.64 Units on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: FAS (DAS28-4 \[ESR\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and PtGA of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity). DAS28-4 (ESR) = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.70\*ln(ESR) + 0.014\*PtGA. Total score range: 0-10, higher score=more disease activity. DAS28-4 (ESR) \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) \<2.6 = clinical remission.
Outcome measures
| Measure |
Tocilizumab
n=49 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)
Month 3 (n=49): Clinical remission
|
38.8 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR)
Month 6 (n=45) : Clinical remission
|
57.8 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: FAS (DAS28-4 \[CRP\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.
The DAS28-4 (CRP) \[described in Outcome Measure 5\] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline \>1.2 with DAS28 \<= 3.2; moderate responders: change from baseline \>1.2 with DAS28 in the range of \>3.2 to \<=5.1 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 in the range of \>3.2 to \<=5.1 or change from baseline \>1.2 with DAS28 \>5.1 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 \<=3.2; non-responders: change from baseline \<= 0.6 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 \>5.1 or change from baseline \<=0.6 with DAS28 \<=3.2 or in the range of \>3.2 to \<=5.1.
Outcome measures
| Measure |
Tocilizumab
n=69 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
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Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
Month 3: Good response (n=69)
|
43.5 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
Month 3: Moderate response (n=69)
|
33.3 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
Month 3: No response (n=69)
|
23.2 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
Month 6: Good response (n=60)
|
43.3 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
Month 6: Moderate response (n=60)
|
33.3 percentage of participants
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP)
Month 6: No response (n=60)
|
23.3 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: FAS (DAS28-4 \[ESR\]). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.
The DAS28-4 (ESR) \[described in Outcome Measure 7\] based EULAR response criteria were used to measure individual response as good, moderate, or no response depending on the extent of change from baseline in DAS28 score and the level of disease activity (low, moderate or high) reached. Good responders: change from baseline \>1.2 with DAS28 \<= 3.2; moderate responders: change from baseline \>1.2 with DAS28 in the range of \>3.2 to \<=5.1 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 in the range of \>3.2 to \<=5.1 or change from baseline \>1.2 with DAS28 \>5.1 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 \<=3.2; non-responders: change from baseline \<= 0.6 or change from baseline in the range of \>0.6 to \<=1.2 with DAS28 \>5.1 or change from baseline \<=0.6 with DAS28 \<=3.2 or in the range of \>3.2 to \<=5.1.
Outcome measures
| Measure |
Tocilizumab
n=49 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
Month 3: Good response (n=49)
|
51.0 percentage of participants
|
|
Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
Month 3: Moderate response (n=49)
|
34.7 percentage of participants
|
|
Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
Month 3: No response (n=49)
|
14.3 percentage of participants
|
|
Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
Month 6: Good response (n=45)
|
55.6 percentage of participants
|
|
Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
Month 6: Moderate response (n=45)
|
31.1 percentage of participants
|
|
Percentage of Participants With EULAR Response Based on DAS28-4 (ESR)
Month 6: No response (n=45)
|
13.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The FAS (SDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for SDAI. n = participants evaluable for this measure at specified timepoint.
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and physician global assessment (PGA) assessed on 0-10 centimeter (cm) VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity.
Outcome measures
| Measure |
Tocilizumab
n=34 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Simplified Disease Activity Index (SDAI)
Baseline (n=34)
|
22.46 Units on a scale
Standard Deviation 11.33
|
|
Simplified Disease Activity Index (SDAI)
Month 3 (n=31)
|
11.48 Units on a scale
Standard Deviation 9.18
|
|
Simplified Disease Activity Index (SDAI)
Month 6 (n=24)
|
10.73 Units on a scale
Standard Deviation 11.74
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: FAS (SDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity, and CRP (mg/dL). SDAI total score = 0-86. SDAI \<=3.3 indicates clinical remission, \>3.4 to 11 = low disease activity, \>11 to 26 = moderate disease activity, and \>26 = high (or severe) disease activity.
Outcome measures
| Measure |
Tocilizumab
n=31 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants Achieving Clinical Remission Based on SDAI
Month 3 (n=31): Clinical remission
|
12.9 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission Based on SDAI
Month 6 (n=24): Clinical remission
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The FAS (CDAI) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for CDAI. n = participants evaluable for this measure at specified timepoint.
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity.
Outcome measures
| Measure |
Tocilizumab
n=35 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Clinical Disease Activity Index (CDAI)
Baseline (n=35)
|
21.3 Units on a scale
Standard Deviation 10.9
|
|
Clinical Disease Activity Index (CDAI)
Month 3 (n=33)
|
10.9 Units on a scale
Standard Deviation 8.9
|
|
Clinical Disease Activity Index (CDAI)
Month 6 (n=24)
|
10.4 Units on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: FAS (CDAI). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.
The CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PtGA and PGA assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI \<= 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high (or severe) disease activity.
Outcome measures
| Measure |
Tocilizumab
n=33 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants Achieving Clinical Remission Based on CDAI
Month 3 (n=33): Clinical remission
|
12.1 percentage of participants
|
|
Percentage of Participants Achieving Clinical Remission Based on CDAI
Month 3 (n=24): Clinical remission
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Data for ACR response was not reported because in clinical practice the 66/68 joint evaluation needed for this is not performed in the Sweden, Denmark and Norway, the 28 joint count is performed instead.
ACR response: improvement in tender or swollen joint counts and improvement in 3 of the following 5 criteria: 1) PGA of disease activity, 2) PtGA of disease activity, 3) patient's assessment of pain, 4) patient's assessment of functional disability via a health assessment questionnaire, and 5) CRP at each visit. ACR response is based on 66/68 total joint count.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The FAS (VAS disease activity \[patient\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (patient). n = participants evaluable for this measure at specified timepoint.
Patient Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.
Outcome measures
| Measure |
Tocilizumab
n=87 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Patient Global Assessment (PtGA) of Disease Activity Score
Baseline (n=87)
|
61.6 mm
Standard Deviation 21.4
|
|
Patient Global Assessment (PtGA) of Disease Activity Score
Month 3 (n=77)
|
41.3 mm
Standard Deviation 25.9
|
|
Patient Global Assessment (PtGA) of Disease Activity Score
Month 6 (n=69)
|
41.6 mm
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The FAS (VAS disease activity \[physician\] included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS disease activity (physician). n = participants evaluable for this measure at specified timepoint.
Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity.
Outcome measures
| Measure |
Tocilizumab
n=42 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Physician Global Assessment (PGA) of Disease Activity
Baseline (n=42)
|
34.0 mm
Standard Deviation 16.4
|
|
Physician Global Assessment (PGA) of Disease Activity
Month 3 (n=37)
|
19.1 mm
Standard Deviation 17.2
|
|
Physician Global Assessment (PGA) of Disease Activity
Month 6 (n=30)
|
15.2 mm
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: FAS (categorical scale \[physician\]) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for rheumatoid arthritis illness categorical scale (physician). n = participants evaluable for this measure at specified timepoint.
A categorical scale (Lickert scale) with the following categories: none, mild, moderate, severe and maximal was used to evaluate disease activity in clinical practice.
Outcome measures
| Measure |
Tocilizumab
n=51 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Month 6: Moderate (n=46)
|
4.9 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Baseline: Mild (n=51)
|
2.0 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Baseline: Moderate (n=51)
|
56.9 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Baseline: Severe (n=51)
|
33.3 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Baseline: Maximal (n=51)
|
7.8 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Month 3: None (n=46)
|
8.7 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Month 3: Mild (n=46)
|
52.2 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Month 3: Moderate (n=46)
|
28.3 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Month 3: Severe (n=46)
|
10.9 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Month 6: None (n=41)
|
7.3 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Month 6: Mild (n=46)
|
78.0 percentage of participants
|
|
Percentage of Participants in a PGA of Disease Activity Score Category
Month 6: Severe (n=46)
|
9.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: The FAS (VAS pain) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for VAS pain. n = participants evaluable for this measure at specified timepoint.
Patient Global Assessment of Pain was assessed using a 100 mm VAS (0 to 100) where 0 = no pain to 100 = worst possible pain.
Outcome measures
| Measure |
Tocilizumab
n=83 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Patient Global Assessment of Pain
Baseline (n=83)
|
60.5 mm
Standard Deviation 22.3
|
|
Patient Global Assessment of Pain
Month 3 (n=73)
|
38.4 mm
Standard Deviation 24.5
|
|
Patient Global Assessment of Pain
Month 6 (n=68)
|
39.9 mm
Standard Deviation 27.1
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: FAS (morning stiffness) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or 6) for morning stiffness. n = participants evaluable for this measure at specified timepoint.
The percentage of participants with morning stiffness ("yes", "no", or "do not know") was assessed at each visit.
Outcome measures
| Measure |
Tocilizumab
n=89 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants With Morning Stiffness
Baseline: Yes (n=89)
|
55.1 percentage of participants
|
|
Percentage of Participants With Morning Stiffness
Baseline: No (n=89)
|
9.0 percentage of participants
|
|
Percentage of Participants With Morning Stiffness
Baseline: Do Not Know (n=89)
|
36.0 percentage of participants
|
|
Percentage of Participants With Morning Stiffness
Month 3: Yes (n=80)
|
47.5 percentage of participants
|
|
Percentage of Participants With Morning Stiffness
Month 3: No (n=80)
|
3.8 percentage of participants
|
|
Percentage of Participants With Morning Stiffness
Month 3: Do Not Know (n=80)
|
48.8 percentage of participants
|
|
Percentage of Participants With Morning Stiffness
Month 6: Yes (n=68)
|
36.8 percentage of participants
|
|
Percentage of Participants With Morning Stiffness
Month 6: No (n=68)
|
14.7 percentage of participants
|
|
Percentage of Participants With Morning Stiffness
Month 6: Do Not Know (n=68)
|
48.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6Population: FAS (morning stiffness). N (number of participants analyzed) = participants evaluable for this measure. n = participants evaluable for this measure at specified timepoint.
Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. Duration was recorded as less than (\<) 30 minutes, 30 to 60 minutes, 60 to 120 minutes, 120 to 240 minutes, more than (\>) 240 minutes, or whole day.
Outcome measures
| Measure |
Tocilizumab
n=49 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants With Duration of Morning Stiffness
Baseline: <30 minutes (n=49)
|
10.2 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Baseline: 30 to 60 minutes (n=49)
|
24.5 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Baseline: 60 to 120 minutes (n=49)
|
32.7 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Baseline: 120 to 240 minutes (n=49)
|
20.4 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Baseline: >240 minutes (n=49)
|
6.1 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Baseline: whole day (n=49)
|
6.1 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 3: <30 minutes (n=38)
|
28.9 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 3: 30 to 60 minutes (n=38)
|
28.9 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 3: 60 to 120 minutes (n=38)
|
23.7 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 3: 120 to 240 minutes (n=38)
|
15.8 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 3: >240 minutes (n=38)
|
0 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 3: whole day (n=38)
|
2.6 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 6: <30 minutes (n=25)
|
44.0 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 6: 30 to 60 minutes (n=25)
|
28.0 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 6: 60 to 120 minutes (n=25)
|
4.0 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 6: 120 to 240 minutes (n=25)
|
20.0 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 6: >240 minutes (n=25)
|
0 percentage of participants
|
|
Percentage of Participants With Duration of Morning Stiffness
Month 6: whole day (n=25)
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3 and Month 6Population: The FAS (HAQ) included all data from all participants who had at least a baseline value and one follow up value (Month 3 or Month 6) for HAQ.
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
Tocilizumab
n=82 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6
Baseline (n=82)
|
1.29 units on a scale
Standard Deviation 0.62
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6
Change at Month 3 (n=72)
|
-0.29 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6
Change at Month 6 (n=58)
|
-0.21 units on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Safety Analysis Set
Outcome measures
| Measure |
Tocilizumab
n=107 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Percentage of Participants With Concomitant Corticosteroids Treatment
|
26.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Month 6Population: Safety Analysis Set
Outcome measures
| Measure |
Tocilizumab
n=107 Participants
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study
|
1 participants
|
Adverse Events
Tocilizumab
Serious adverse events
| Measure |
Tocilizumab
n=107 participants at risk
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Infections and infestations
Ear infection
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Infections and infestations
Infection
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Investigations
Alanine aminotransferase increased
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Investigations
Blood lactic acid increased
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Investigations
C-reactive protein increased
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Anaemia
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Cardiac disorders
Cardiac failure
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
|
Vascular disorders
Femoral artery occlusion
|
0.93%
1/107 • Baseline to Month 6
Safety Analysis Set
|
Other adverse events
| Measure |
Tocilizumab
n=107 participants at risk
Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.5%
7/107 • Baseline to Month 6
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
5.6%
6/107 • Baseline to Month 6
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER