Trial Outcomes & Findings for A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting (NCT NCT01664104)
NCT ID: NCT01664104
Last Updated: 2017-07-13
Results Overview
Percentage of participants on TCZ treatment at Month 6 was calculated as: \[(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.
COMPLETED
151 participants
Month 6
2017-07-13
Participant Flow
A total of 151 participants were enrolled in the study; of which,136 participants met the eligibility criteria. The results are reported only for those participants who met the eligibility criteria.
Participant milestones
| Measure |
Rheumatoid Arthritis (RA) Participants
Participants with moderate or severe RA who were under tocilizumab (TCZ) treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Overall Study
STARTED
|
136
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Rheumatoid Arthritis (RA) Participants
Participants with moderate or severe RA who were under tocilizumab (TCZ) treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Other
|
1
|
|
Overall Study
Unknown: Reason Unrelated to TCZ
|
2
|
Baseline Characteristics
A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting
Baseline characteristics by cohort
| Measure |
RA Participants
n=133 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: All enrolled participants evaluable for primary objective.
Percentage of participants on TCZ treatment at Month 6 was calculated as: \[(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.
Outcome measures
| Measure |
RA Participants
n=133 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants on TCZ Treatment at Month 6
|
86.5 percentage of participants
Interval 79.46 to 91.78
|
SECONDARY outcome
Timeframe: Month 6Population: All enrolled participants evaluable for primary objective and who did not interrupt TCZ at Month 6.
TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the \[(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)\] multiplied by 100.
Outcome measures
| Measure |
RA Participants
n=115 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by TCZ Dose at Month 6
Not available
|
0.87 percentage of participants
|
|
Percentage of Participants by TCZ Dose at Month 6
8 milligrams per kilogram (mg/kg)
|
93.91 percentage of participants
|
|
Percentage of Participants by TCZ Dose at Month 6
4 mg/kg
|
1.74 percentage of participants
|
|
Percentage of Participants by TCZ Dose at Month 6
6.35 mg/kg
|
0.87 percentage of participants
|
|
Percentage of Participants by TCZ Dose at Month 6
7.1 mg/kg
|
0.87 percentage of participants
|
|
Percentage of Participants by TCZ Dose at Month 6
7.6 mg/kg
|
0.87 percentage of participants
|
|
Percentage of Participants by TCZ Dose at Month 6
6.4 mg/kg
|
0.87 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective.
Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in "IR to biologic group". Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the "DMARDs intolerance and/or IR" group.
Outcome measures
| Measure |
RA Participants
n=133 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
IR to biologic treatment
|
62.4 percentage of participants
|
|
Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Intolerance or IR to DMARDs
|
37.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (assessed retrospectively)Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.
Outcome measures
| Measure |
RA Participants
n=131 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Time Elapsed From Diagnosis of RA
|
6.5 years
Interval 0.3 to 49.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.
Outcome measures
| Measure |
RA Participants
n=125 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline
|
61.3 mm
Standard Deviation 28.2
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.
Outcome measures
| Measure |
RA Participants
n=117 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline
|
61.0 mm
Standard Deviation 28.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.
Outcome measures
| Measure |
RA Participants
n=114 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline
|
53.4 mm
Standard Deviation 24.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.
Outcome measures
| Measure |
RA Participants
n=50 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Participant Assessment of Morning Stiffness Using VAS at Baseline
|
47.0 mm
Standard Deviation 32.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.
Outcome measures
| Measure |
RA Participants
n=91 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Participant Assessment of Fatigue Using VAS at Baseline
|
57.1 mm
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.
Outcome measures
| Measure |
RA Participants
n=111 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline
|
1.4 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.
Outcome measures
| Measure |
RA Participants
n=130 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Tender Joint Count (TJC) at Baseline
|
11.5 tender joints
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.
Outcome measures
| Measure |
RA Participants
n=130 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Swollen Joint Count (SJC) at Baseline
|
6.7 swollen joints
Standard Deviation 5.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
RA Participants
n=131 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Erythrocyte Sedimentation Rate (ESR) at Baseline
|
33.0 mm/hour
Standard Deviation 25.1
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
RA Participants
n=126 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
C-Reactive Protein (CRP) at Baseline
|
2.7 milligrams per deciliter (mg/dL)
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.
Outcome measures
| Measure |
RA Participants
n=128 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline
|
7.0 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Outcome measures
| Measure |
RA Participants
n=114 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Evidence of Structural Joint Damage at Baseline
|
71.9 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Outcome measures
| Measure |
RA Participants
n=124 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline
|
12.9 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.
Outcome measures
| Measure |
RA Participants
n=116 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline
|
59.5 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Outcome measures
| Measure |
RA Participants
n=103 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline
|
58.3 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective.
Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (\<) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (\>) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.
Outcome measures
| Measure |
RA Participants
n=133 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by Duration of Morning Stiffness at Baseline
> 240 minutes
|
3.8 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness at Baseline
The whole day
|
2.3 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness at Baseline
No morning stiffness
|
6.8 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness at Baseline
< 30 minutes
|
15.0 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness at Baseline
Between 30 - 60 minutes
|
30.1 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness at Baseline
Between 60 - 120 minutes
|
25.6 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness at Baseline
Between 120 - 240 minutes
|
4.5 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness at Baseline
Not estimable
|
12.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for the primary objective and had TCZ dose modification.
Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.
Outcome measures
| Measure |
RA Participants
n=6 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Number of Participants With TCZ Dose Change According to the Reason for Change
Adverse event
|
3 participants
|
|
Number of Participants With TCZ Dose Change According to the Reason for Change
Physician decision
|
1 participants
|
|
Number of Participants With TCZ Dose Change According to the Reason for Change
Weight variation
|
1 participants
|
|
Number of Participants With TCZ Dose Change According to the Reason for Change
Other
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective.
The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.
Outcome measures
| Measure |
RA Participants
n=133 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by Number of TCZ Dose Modifications Per Participant
0 dose modification
|
95.49 percentage of participants
|
|
Percentage of Participants by Number of TCZ Dose Modifications Per Participant
1 dose modification
|
1.50 percentage of participants
|
|
Percentage of Participants by Number of TCZ Dose Modifications Per Participant
2 dose modifications
|
3.01 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.
The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.
Outcome measures
| Measure |
RA Participants
n=130 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Time in Days Elapsed Between TCZ Infusions
Infusion 4 and Infusion 5
|
30 days
Interval 28.0 to 35.0
|
|
Time in Days Elapsed Between TCZ Infusions
Infusion 5 and Infusion 6
|
31 days
Interval 28.0 to 35.0
|
|
Time in Days Elapsed Between TCZ Infusions
Infusion 1 and Infusion 2
|
31 days
Interval 28.0 to 35.0
|
|
Time in Days Elapsed Between TCZ Infusions
Infusion 2 and Infusion 3
|
31.5 days
Interval 28.5 to 34.0
|
|
Time in Days Elapsed Between TCZ Infusions
Infusion 3 and Infusion 4
|
31 days
Interval 28.0 to 35.0
|
|
Time in Days Elapsed Between TCZ Infusions
Infusion 6 and Infusion 7
|
29 days
Interval 28.0 to 33.0
|
|
Time in Days Elapsed Between TCZ Infusions
Infusion 7 and Infusion 8
|
28 days
Interval 28.0 to 31.0
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective.
The percentage of participants with at least one infusion interruption was reported as "Yes". Participants with unknown infusion interruption were set to "No".
Outcome measures
| Measure |
RA Participants
n=133 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With TCZ Infusion Interruption
Yes
|
3.01 percentage of participants
|
|
Percentage of Participants With TCZ Infusion Interruption
No
|
96.99 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective who discontinued TCZ.
Outcome measures
| Measure |
RA Participants
n=18 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation
Adverse event
|
50.0 percentage of participants
|
|
Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation
Lack of or insufficient efficacy
|
33.33 percentage of participants
|
|
Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation
Unspecified
|
16.67 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective.
The percentage of participants with at least one TCZ reintroduction was reported as "Yes". Participants with unknown TCZ reintroduction were set to "No".
Outcome measures
| Measure |
RA Participants
n=133 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With TCZ Reintroduction
Yes
|
1.5 percentage of participants
|
|
Percentage of Participants With TCZ Reintroduction
No
|
98.5 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Outcome measures
| Measure |
RA Participants
n=40 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline
Lack of DMARD efficacy
|
12.5 percentage of participants
|
|
Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline
DMARD intolerability
|
85 percentage of participants
|
|
Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline
Both lack of efficacy and intolerability to DMARDs
|
2.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of \< 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of \> 3.2 and ≤ 5.1 represents moderate disease activity and a score of \> 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Outcome measures
| Measure |
RA Participants
n=37 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6
Baseline
|
5.16 units on a scale
Standard Deviation 1.06
|
|
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6
Change at Month 3
|
1.99 units on a scale
Standard Deviation 1.04
|
|
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6
Change at Month 6
|
2.15 units on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and \> 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Outcome measures
| Measure |
RA Participants
n=61 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6
Baseline
|
35.12 units on a scale
Standard Deviation 20.50
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6
Change at Month 3
|
19.37 units on a scale
Standard Deviation 17.08
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6
Change at Month 6
|
20.35 units on a scale
Standard Deviation 22.00
|
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of \> 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Outcome measures
| Measure |
RA Participants
n=80 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6
Change at Month 3
|
15.06 units on a scale
Standard Deviation 13.56
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6
Baseline
|
30.48 units on a scale
Standard Deviation 13.62
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6
Change at Month 6
|
15.96 units on a scale
Standard Deviation 15.73
|
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for this outcome and number analyzed = participants with available data for specified category.
DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of \< 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of \>3.2 and ≤ 5.1 represents moderate disease activity, and a score of \> 5.1 represents high (or severe) disease activity.
Outcome measures
| Measure |
RA Participants
n=92 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: DAS28 ≥ 2.6 to ≤ 3.2
|
1.8 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: DAS28 > 5.1
|
8.1 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: DAS28 < 2.6
|
3.5 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: DAS28 > 3.2 to ≤ 5.1
|
43.9 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: DAS28 > 5.1
|
50.9 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: DAS28 < 2.6
|
30.4 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: DAS28 ≥ 2.6 to ≤ 3.2
|
14.1 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: DAS28 >3.2 to ≤ 5.1
|
50.0 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: DAS28 > 5.1
|
5.4 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: DAS28 < 2.6
|
33.7 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: DAS28 ≥ 2.6 to ≤ 3.2
|
15.1 percentage of participants
|
|
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: DAS28 >3.2 to ≤ 5.1
|
43.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.
SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and \> 26.0 represents high (or severe) disease activity.
Outcome measures
| Measure |
RA Participants
n=93 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: SDAI ≤ 11.0
|
7.5 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: SDAI ≤ 26.0
|
80.7 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: SDAI ≤ 3.3
|
2.2 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: SDAI ≤ 26.0
|
36.6 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: SDAI > 26.0
|
63.4 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: SDAI ≤ 3.3
|
7.2 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: SDAI ≤ 11.0
|
34.9 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: SDAI > 26.0
|
19.3 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: SDAI ≤ 3.3
|
13.8 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: SDAI ≤ 11.0
|
47.5 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: SDAI ≤ 26.0
|
82.5 percentage of participants
|
|
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: SDAI > 26.0
|
17.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.
CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of \> 22.0 represents high (or severe) disease activity.
Outcome measures
| Measure |
RA Participants
n=97 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: CDAI ≤ 22.0
|
78.7 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: CDAI ≤ 2.8
|
2.1 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: CDAI ≤ 10.0
|
8.2 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: CDAI ≤ 22.0
|
24.7 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Baseline: CDAI > 22.0
|
75.3 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: CDAI ≤ 2.8
|
7.4 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: CDAI ≤ 10.0
|
36.2 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: CDAI ≤ 22.0
|
77.7 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 3: CDAI > 22.0
|
22.3 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: CDAI ≤ 2.8
|
10.6 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: CDAI ≤ 10.0
|
42.6 percentage of participants
|
|
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6
Month 6: CDAI > 22.0
|
21.3 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.
Outcome measures
| Measure |
RA Participants
n=120 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 90 not achieved
|
89.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 20 achieved
|
45 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 20 not achieved
|
38.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 20 at least 1 missing data
|
16.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 50 achieved
|
23.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 50 not achieved
|
62.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 50 at least 1 missing data
|
14.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 70 achieved
|
9.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 70 not achieved
|
79.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 70 at least 1 missing data
|
11.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 90 achieved
|
1.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 90 not achieved
|
90.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 3: ACR 90 at least 1 missing data
|
8.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 20 achieved
|
51.7 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 20 not achieved
|
35.8 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 20 at least 1 missing data
|
12.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 50 achieved
|
27.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 50 not achieved
|
57.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 50 at least 1 missing data
|
15.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 70 achieved
|
12.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 70 not achieved
|
73.3 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 70 at least 1 missing data
|
14.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 90 achieved
|
2.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment
Month 6: ACR 90 at least 1 missing data
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
TJC 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 baseline and at Month 6. No tenderness = 0 and tenderness = 1.
Outcome measures
| Measure |
RA Participants
n=114 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline to Month 6 in TJC
|
6.0 tender joints
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
SJC 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 baseline and at Month 6. No swelling = 0 and swelling = 1.
Outcome measures
| Measure |
RA Participants
n=114 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline to Month 6 in SJC
|
4.2 swollen joints
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for the primary objective with available data for this outcome measure.
The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.
Outcome measures
| Measure |
RA Participants
n=96 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline to Month 6 in PGH
|
21.4 mm
Standard Deviation 26.1
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for the primary objective with available data for this outcome measure.
The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.
Outcome measures
| Measure |
RA Participants
n=93 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline to Month 6 in PhGH
|
23.9 mm
Standard Deviation 26.2
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.
Outcome measures
| Measure |
RA Participants
n=107 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline to Month 6 in Patient's Assessment of Pain
|
22.5 mm
Standard Deviation 26.4
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for the primary objective with available data for this outcome measure.
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.
Outcome measures
| Measure |
RA Participants
n=89 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline to Month 6 in HAQ-DI Score
|
0.4 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for the primary objective with available data for this outcome measure.
Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.
Outcome measures
| Measure |
RA Participants
n=68 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline to Month 6 in Participant Assessment of Fatigue
|
17.9 mm
Standard Deviation 23.1
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.
Outcome measures
| Measure |
RA Participants
n=35 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness
|
18.8 mm
Standard Deviation 31.6
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.
Outcome measures
| Measure |
RA Participants
n=120 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI
Month 3
|
36.7 percentage of participants
|
|
Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI
Month 6
|
45.8 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.
Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of \>1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL \>1.2 with DAS28 score \> 3.2 to ≤ 5.1 or a chg from BL \> 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL \< 0.6 regardless initial DAS28 score or \> 0.6 to ≤ 1.2 with DAS28 score of \> 5.1.
Outcome measures
| Measure |
RA Participants
n=46 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Month 3: Good response
|
41.3 percentage of participants
|
|
Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Month 3: Moderate response
|
47.8 percentage of participants
|
|
Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Month 3: No response
|
10.9 percentage of participants
|
|
Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Month 6: Good response
|
45.5 percentage of participants
|
|
Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Month 6: Moderate response
|
40.9 percentage of participants
|
|
Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
Month 6: No response
|
13.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
DMARDs that met the criteria for "concomitant medications" were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered.
Outcome measures
| Measure |
RA Participants
n=9 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Time to DMARD Dose Reduction
|
3.2 months
Interval 1.0 to 4.6
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
DMARDs that met the criteria for "concomitant medications" were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.
Outcome measures
| Measure |
RA Participants
n=11 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Time to DMARD Dose Withdrawal
|
4.1 months
Interval 2.9 to 5.2
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
DMARDs that met the criteria for "concomitant medications" were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected.
Outcome measures
| Measure |
RA Participants
n=11 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by Reason for DMARD Withdrawal During the Study
Subjective intolerance
|
9.09 percentage of participants
|
|
Percentage of Participants by Reason for DMARD Withdrawal During the Study
Objective intolerance
|
36.36 percentage of participants
|
|
Percentage of Participants by Reason for DMARD Withdrawal During the Study
Unspecified
|
36.36 percentage of participants
|
|
Percentage of Participants by Reason for DMARD Withdrawal During the Study
Lack of efficacy
|
18.18 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Steroids that met the criteria for "concomitant medications" were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered.
Outcome measures
| Measure |
RA Participants
n=18 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Time to Steroid Dose Reduction
|
2.3 months
Interval 1.7 to 4.6
|
SECONDARY outcome
Timeframe: Baseline up to Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Steroids that met the criteria for "concomitant medications" were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.
Outcome measures
| Measure |
RA Participants
n=7 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Time to Steroid Dose Withdrawal
|
1.8 months
Interval 1.1 to 3.1
|
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Outcome measures
| Measure |
RA Participants
n=89 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline in CRP at Month 3 and Month 6
Change at Month 6
|
1.98 mg/dL
Standard Deviation 8.87
|
|
Change From Baseline in CRP at Month 3 and Month 6
Change at Month 3
|
2.28 mg/dL
Standard Deviation 8.61
|
SECONDARY outcome
Timeframe: Baseline, Month 3, and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Outcome measures
| Measure |
RA Participants
n=100 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Change From Baseline in ESR at Month 3 and Month 6
Change at Month 3
|
23.15 mm/hr
Standard Deviation 21.72
|
|
Change From Baseline in ESR at Month 3 and Month 6
Change at Month 6
|
21.42 mm/hr
Standard Deviation 23.21
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of \< 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.
Outcome measures
| Measure |
RA Participants
n=89 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
Without DAS28-CRP clinical remission
|
3.1 mg/dL
Standard Deviation 10.5
|
|
CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
With DAS28-CRP clinical remission
|
2.2 mg/dL
Standard Deviation 6.2
|
|
CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
With SDAI clinical remission
|
4.6 mg/dL
Standard Deviation 10.6
|
|
CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
Without SDAI clinical remission
|
2.8 mg/dL
Standard Deviation 9.5
|
|
CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
With CDAI clinical remission
|
4.2 mg/dL
Standard Deviation 10.0
|
|
CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6
Without CDAI clinical remission
|
2.7 mg/dL
Standard Deviation 8.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.
DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of \< 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.
Outcome measures
| Measure |
RA Participants
n=91 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
With DAS-28 CRP clinical remission
|
23.3 kilogram per meter square (Kg/m^2)
Standard Deviation 3.2
|
|
Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
Without DAS-28 CRP clinical remission
|
26.7 kilogram per meter square (Kg/m^2)
Standard Deviation 5.0
|
|
Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
With SDAI clinical remission
|
23.7 kilogram per meter square (Kg/m^2)
Standard Deviation 3.2
|
|
Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
Without SDAI clinical remission
|
26.0 kilogram per meter square (Kg/m^2)
Standard Deviation 5.0
|
|
Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
With CDAI clinical remission
|
23.8 kilogram per meter square (Kg/m^2)
Standard Deviation 3.3
|
|
Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6
Without CDAI clinical remission
|
26.6 kilogram per meter square (Kg/m^2)
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria: 1. Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present); 2. Duration of morning stiffness, measured by ticking 1 of the six categories: \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day; 3. Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.
Outcome measures
| Measure |
RA Participants
n=120 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants With and Without Morning Stiffness
Month 3 (with morning stiffness)
|
70.0 percentage of participants
|
|
Percentage of Participants With and Without Morning Stiffness
Month 3 (without morning stiffness)
|
15.8 percentage of participants
|
|
Percentage of Participants With and Without Morning Stiffness
Month 3 (morning stiffness not estimable)
|
10.8 percentage of participants
|
|
Percentage of Participants With and Without Morning Stiffness
Month 3 (morning stiffness not done)
|
3.3 percentage of participants
|
|
Percentage of Participants With and Without Morning Stiffness
Month 6 (with morning stiffness)
|
65.0 percentage of participants
|
|
Percentage of Participants With and Without Morning Stiffness
Month 6 (without morning stiffness)
|
25.8 percentage of participants
|
|
Percentage of Participants With and Without Morning Stiffness
Month 6 (morning stiffness not estimable)
|
9.2 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3 and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.
Outcome measures
| Measure |
RA Participants
n=120 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Percentage of Participants by Duration of Morning Stiffness
Month 3 (no morning stiffness)
|
15.8 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 6 (no morning stiffness)
|
25.8 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 3 (< 30 minutes)
|
40.8 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 6 (< 30 minutes)
|
35.0 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 3 (between 30 - 60 minutes )
|
20.0 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 6 (between 30 - 60 minutes)
|
21.7 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 3 (Between 60 - 240 minutes)
|
7.5 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 6 (Between 60 - 240 minutes)
|
7.5 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 3 (> 240 minutes)
|
0.8 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 6 (> 240 minutes)
|
0 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 3 (whole day)
|
0 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 6 (whole day)
|
0.8 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 3 (not estimable)
|
11.7 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 6 (not estimable)
|
9.2 percentage of participants
|
|
Percentage of Participants by Duration of Morning Stiffness
Month 3 (not done)
|
3.3 percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and \> 30 minutes.
Outcome measures
| Measure |
RA Participants
n=40 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6
Morning stiffness (≤ 30 minutes)
|
3.3 mg/dL
Standard Deviation 12.0
|
|
CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6
Morning stiffness (> 30 minutes)
|
2.1 mg/dL
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: BaselinePopulation: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.
Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and \> 30 minutes.
Outcome measures
| Measure |
RA Participants
n=39 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6
Morning stiffness (≤ 30 minutes)
|
26.1 Kg/m^2
Standard Deviation 4.0
|
|
BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6
Morning stiffness (> 30 minutes)
|
26.6 Kg/m^2
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Outcome measures
| Measure |
RA Participants
n=89 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
Pearson correlation
|
0.12663 correlation coefficient
|
|
Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
Spearman correlation
|
0.02678 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Outcome measures
| Measure |
RA Participants
n=72 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6
Pearson correlation
|
0.25513 correlation coefficient
|
|
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6
Spearman correlation
|
0.21125 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Outcome measures
| Measure |
RA Participants
n=75 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6
Pearson correlation
|
0.08180 correlation coefficient
|
|
Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6
Spearman correlation
|
-0.11521 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Outcome measures
| Measure |
RA Participants
n=59 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6
Pearson correlation
|
0.41350 correlation coefficient
|
|
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6
Spearman correlation
|
0.40842 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene,reach, grip and common activities over past week. Each question was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Outcome measures
| Measure |
RA Participants
n=48 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
Pearson correlation
|
0.08505 correlation coefficient
|
|
Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6
Spearman correlation
|
0.12488 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Outcome measures
| Measure |
RA Participants
n=35 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6
Pearson correlation
|
0.41875 correlation coefficient
|
|
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6
Spearman correlation
|
0.40754 correlation coefficient
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.
Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Outcome measures
| Measure |
RA Participants
n=42 Participants
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6
Pearson correlation
|
0.00181 correlation coefficient
|
|
Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6
Spearman correlation
|
-0.07250 correlation coefficient
|
Adverse Events
RA Participants
Serious adverse events
| Measure |
RA Participants
n=136 participants at risk
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Nervous system disorders
Amyotrophic Lateral Sclerosis
|
0.74%
1/136 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Safety Analysis Set: Participants evaluable at enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.74%
1/136 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Safety Analysis Set: Participants evaluable at enrollment.
|
Other adverse events
| Measure |
RA Participants
n=136 participants at risk
Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
8/136 • Adverse events (AEs) were recorded from enrollment up to 6 months (final visit).
Safety Analysis Set: Participants evaluable at enrollment.
|
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