Trial Outcomes & Findings for A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab) (NCT NCT01663506)

NCT ID: NCT01663506

Last Updated: 2019-12-10

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 23 participants
• Primary outcome timeframe: 6 Months
• Results posted on: 2019-12-10

Participant Flow

Participant milestones

Measure	Tocilizumab Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Overall Study STARTED	23
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Tocilizumab Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Overall Study Lack of Efficacy	3
Overall Study Consent Withdrawal by Subject	1
Overall Study Lost to Follow-up	1
Overall Study Adverse Event	1
Overall Study Switched to Subcutaneous Tocilizumab	2

Baseline Characteristics

A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)

Baseline characteristics by cohort

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Age, Continuous	52.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: FAS.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation	73.9 percentage of participants Interval 51.6 to 89.9

SECONDARY outcome

Timeframe: Month 12

Population: FAS.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation	69.6 percentage of participants Interval 47.1 to 86.8

SECONDARY outcome

Timeframe: Up to Month 12

Population: FAS.

Dose modification was defined as an increase or decrease in the dose of study drug compared to the previous dose received. Interruption was defined as temporary or permanent discontinuation of study drug due to any reason, for example adverse event. Irregularity was defined as a time interval of greater than and equal to (>=) 75 days between two consecutive doses of study drug.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity Dose Modification	26.1 percentage of participants
Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity Dose Modification + Interruption	39.1 percentage of participants
Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity Dose Modification + Interruption + Irregularity	39.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS.

Participants were assessed for any comorbidity at study entry including anemia, fatigue, conventional risk factors for cardiovascular disease, C-reactive protein (CRP) level above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis, interstitial lung disease, and so on. Number of participants with each comorbidity was reported. One participant could have presented with more than 1 comorbidity.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants With Comorbidities at Baseline Spinal column stenosis	1 participants
Number of Participants With Comorbidities at Baseline Anemia	1 participants
Number of Participants With Comorbidities at Baseline Iron deficiency anemia	1 participants
Number of Participants With Comorbidities at Baseline Atrial fibrillation	1 participants
Number of Participants With Comorbidities at Baseline Hypothyroidism	3 participants
Number of Participants With Comorbidities at Baseline Chronic gastritis	2 participants
Number of Participants With Comorbidities at Baseline Duodenitis	1 participants
Number of Participants With Comorbidities at Baseline Duodenal ulcer perforation	1 participants
Number of Participants With Comorbidities at Baseline Dyspepsia	1 participants
Number of Participants With Comorbidities at Baseline Gastric disorder	2 participants
Number of Participants With Comorbidities at Baseline Inguinal hernia	1 participants
Number of Participants With Comorbidities at Baseline Large intestine polyp	1 participants
Number of Participants With Comorbidities at Baseline Cholelithiasis	1 participants
Number of Participants With Comorbidities at Baseline Hepatic steatosis	1 participants
Number of Participants With Comorbidities at Baseline Latent tuberculosis	1 participants
Number of Participants With Comorbidities at Baseline Pulmonary tuberculosis	1 participants
Number of Participants With Comorbidities at Baseline Hyperlipidaemia	2 participants
Number of Participants With Comorbidities at Baseline Spinal osteoarthritis	2 participants
Number of Participants With Comorbidities at Baseline Osteoarthritis	5 participants
Number of Participants With Comorbidities at Baseline Osteopenia	2 participants
Number of Participants With Comorbidities at Baseline Osteoporosis	2 participants
Number of Participants With Comorbidities at Baseline Rotator cuff syndrome	1 participants
Number of Participants With Comorbidities at Baseline Scoliosis	1 participants
Number of Participants With Comorbidities at Baseline Spondyloarthropathy	1 participants
Number of Participants With Comorbidities at Baseline Spondylolisthesis	1 participants
Number of Participants With Comorbidities at Baseline Haemangioma of liver	1 participants
Number of Participants With Comorbidities at Baseline Ovarian cancer	1 participants
Number of Participants With Comorbidities at Baseline Radiculopathy	1 participants
Number of Participants With Comorbidities at Baseline Cervical radiculopathy	1 participants
Number of Participants With Comorbidities at Baseline Gynaecomastia	1 participants
Number of Participants With Comorbidities at Baseline Chronic obstructive pulmonary disease	1 participants
Number of Participants With Comorbidities at Baseline Hypertension	9 participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs) No Prior DMARDs	1 participants
Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs) 1 Prior DMARD	1 participants
Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs) 2 Prior DMARDs	5 participants
Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs) 3 Prior DMARDs	7 participants
Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs) 4 Prior DMARDs	5 participants
Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs) 5 Prior DMARDs	4 participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants With Prior Exposure of Biologics No Prior Biologics	12 participants
Number of Participants With Prior Exposure of Biologics 1 Prior Biologic	8 participants
Number of Participants With Prior Exposure of Biologics 2 Prior Biologics	3 participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment (PtGA) of disease activity. DAS28 total score range = 0 to 10, where higher scores indicates higher disease activity. DAS28 less than and equal to (<=) 2.6 meant clinical remission; DAS28 <=3.2 meant low disease activity; DAS28 greater than (>) 3.2 to 5.1 implied moderate disease activity; and DAS28 >5.1 implied high disease activity.

Outcome measures

Measure	Tocilizumab n=22 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Disease Activity Score Based on 28-joints Count (DAS28) Baseline (n=22)	5.35 units on a scale Standard Deviation 1.21
Disease Activity Score Based on 28-joints Count (DAS28) Month 3 (n=19)	3.54 units on a scale Standard Deviation 1.20
Disease Activity Score Based on 28-joints Count (DAS28) Month 6 (n=17)	2.91 units on a scale Standard Deviation 1.59
Disease Activity Score Based on 28-joints Count (DAS28) Month 12 (n=11)	2.29 units on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: Month 3, 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.

The DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Description of DAS28 calculation is provided in Outcome Measure 7. Good responders: decrease from baseline >1.2 with DAS28 <= 3.2; moderate responders: decrease from baseline >1.2 with DAS28 >3.2 or decrease from baseline >0.6 to <=1.2 with DAS28 <=5.1; non-responders: decrease from baseline <= 0.6 or decrease from baseline >0.6 and <=1.2 with DAS28 >5.1.

Outcome measures

Measure	Tocilizumab n=22 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 3: Good responders (n=18)	6 participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 3: Moderate responders (n=18)	8 participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 3: Non-responders (n=18)	4 participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 6: Good responders (n=16)	11 participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 6: Moderate responders (n = 16)	2 participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 6: Non-responders (n=16)	3 participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 12: Good responders (n=11)	8 participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 12: Moderate responders (n=11)	2 participants
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Month 12: Non-responders (n=11)	1 participants

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

PGA of disease activity was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity.

Outcome measures

Measure	Tocilizumab n=20 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Physician Global Assessment (PGA) of Disease Activity Baseline (n=20)	58.40 mm Standard Deviation 10.08
Physician Global Assessment (PGA) of Disease Activity Month 6 (n=15)	27.00 mm Standard Deviation 18.34
Physician Global Assessment (PGA) of Disease Activity Month 12 (n=10)	13.80 mm Standard Deviation 13.83

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

PtGA of Disease Activity was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity.

Outcome measures

Measure	Tocilizumab n=22 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Patient Global Assessment (PtGA) of Disease Activity Score Baseline (n=22)	62.68 mm Standard Deviation 17.67
Patient Global Assessment (PtGA) of Disease Activity Score Month 6 (n=17)	36.85 mm Standard Deviation 24.22
Patient Global Assessment (PtGA) of Disease Activity Score Month 12 (n=11)	22.27 mm Standard Deviation 21.00

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

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 was scored on a 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 divided by the number of domains answered. Total possible score range was 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Measure	Tocilizumab n=20 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Baseline (n=20)	1.22 units on a scale Standard Deviation 0.80
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Month 6 (n=10)	0.98 units on a scale Standard Deviation 0.81
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Month 12 (n=6)	0.65 units on a scale Standard Deviation 0.52

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

Intensity of pain was measured on a 100 mm line VAS marked by participant. It ranged (over the past week): 0 = no pain to 100 = worst possible pain.

Outcome measures

Measure	Tocilizumab n=22 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Visual Analog Scale (VAS)-Pain Baseline (n=22)	56.18 mm Standard Deviation 21.64
Visual Analog Scale (VAS)-Pain Month 6 (n=17)	35.00 mm Standard Deviation 23.25
Visual Analog Scale (VAS)-Pain Month 12 (n=11)	22.91 mm Standard Deviation 22.87

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

Participants assessed their fatigue using a 0 - 100 mm VAS, where 0 mm = no fatigue and 100 mm = worst possible fatigue.

Outcome measures

Measure	Tocilizumab n=6 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Visual Analog Fatigue Scale (VAFS) Baseline (n=6)	67.00 mm Standard Deviation 30.66
Visual Analog Fatigue Scale (VAFS) Month 6 (n=5)	39.80 mm Standard Deviation 30.38
Visual Analog Fatigue Scale (VAFS) Month 12 (n=3)	5.67 mm Standard Deviation 6.66

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

Participants assessed their morning stiffness using a 0 - 100 mm VAS, where 0 mm = no stiffness and 100 mm = worst possible stiffness.

Outcome measures

Measure	Tocilizumab n=6 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Visual Analog Scale-Morning Stiffness (VAS-MS) Baseline (n=6)	67.00 mm Standard Deviation 12.54
Visual Analog Scale-Morning Stiffness (VAS-MS) Month 6 (n=5)	23.60 mm Standard Deviation 33.22
Visual Analog Scale-Morning Stiffness (VAS-MS) Month 12 (n=2)	16.00 mm Standard Deviation 19.80

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

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 higher rate is consistent with inflammation.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Erythrocyte Sedimentation Rate (ESR) Baseline (n=23)	36.83 mm/hr Standard Deviation 27.53
Erythrocyte Sedimentation Rate (ESR) Month 6 (n=16)	9.81 mm/hr Standard Deviation 14.11
Erythrocyte Sedimentation Rate (ESR) Month 12 (n=13)	6.54 mm/hr Standard Deviation 6.77

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range is up to 10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
C-Reactive Protein (CRP) Baseline (n=23)	30.16 mg/L Standard Deviation 41.14
C-Reactive Protein (CRP) Month 6 (n=18)	8.54 mg/L Standard Deviation 17.54
C-Reactive Protein (CRP) Month 12 (n=14)	4.07 mg/L Standard Deviation 7.70

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.

Number of swollen joints was determined by examination of 66 joints (SJC66) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 68 joints (TJC68) 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, 0 = no tenderness, 1 = tenderness.

Outcome measures

Measure	Tocilizumab n=7 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Swollen and Tender Joints Based on 66 and 68 Joints SJC66: Baseline (n=7)	4.29 joints count Standard Deviation 2.21
Number of Swollen and Tender Joints Based on 66 and 68 Joints TJC68: Baseline (n=7)	6.86 joints count Standard Deviation 7.99
Number of Swollen and Tender Joints Based on 66 and 68 Joints SJC66: Month 6 (n=1)	0 joints count Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.
Number of Swollen and Tender Joints Based on 66 and 68 Joints TJC68: Month 6 (n=1)	0 joints count Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.
Number of Swollen and Tender Joints Based on 66 and 68 Joints SJC66: Month 12 (n=1)	1.00 joints count Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.
Number of Swollen and Tender Joints Based on 66 and 68 Joints TJC68: Month 12 (n=1)	2.00 joints count Standard Deviation NA Standard deviation was not calculated due to insufficient number of participants analyzed at this time point.

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point for specified category.

Number of swollen joints was determined by examination of 28 (SJC28) joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, 0 = no swelling, 1 = swelling. Number of tender joints was determined by examining 28 joints (TJC28) 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, 0 = no tenderness, 1 = tenderness.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Swollen and Tender Joints Based on 28 Joints SJC28: Baseline (n=23)	6.78 joints count Standard Deviation 4.06
Number of Swollen and Tender Joints Based on 28 Joints TJC28: Baseline (n=23)	9.13 joints count Standard Deviation 7.23
Number of Swollen and Tender Joints Based on 28 Joints SJC28: Month 6 (n=18)	2.56 joints count Standard Deviation 2.79
Number of Swollen and Tender Joints Based on 28 Joints TJC28: Month 6 (n=18)	4.11 joints count Standard Deviation 6.03
Number of Swollen and Tender Joints Based on 28 Joints SJC28: Month 12 (n=13)	1.54 joints count Standard Deviation 2.40
Number of Swollen and Tender Joints Based on 28 Joints TJC28: Month 12 (n=13)	1.92 joints count Standard Deviation 1.85

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

The SDAI is the numerical sum of five outcome parameters: TJC28, SJC28, PtGA, PGA, and CRP. Description of these outcome parameters is given in outcome measure 9, 10, 16, and 18. SDAI total score = 0-86. SDAI <=3.3 indicates disease remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high disease activity.

Outcome measures

Measure	Tocilizumab n=20 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Simplified Disease Activity Index (SDAI) Score Baseline (n=20)	31.99 units on a scale Standard Deviation 10.77
Simplified Disease Activity Index (SDAI) Score Month 6 (n=15)	13.69 units on a scale Standard Deviation 11.60
Simplified Disease Activity Index (SDAI) Score Month 12 (n=10)	7.17 units on a scale Standard Deviation 6.12

SECONDARY outcome

Timeframe: Baseline, Month 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

The CDAI is the numerical sum of 4 outcome parameters: TJC28, SJC28, PtGA, and PGA. Description of these outcome parameters is given come measure 9, 10, and 18. CDAI total score = 0-76. CDAI <= 2.8 indicates disease remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high disease activity.

Outcome measures

Measure	Tocilizumab n=20 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Clinical Disease Activity Index (CDAI) Score Baseline (n=20)	28.68 units on a scale Standard Deviation 10.21
Clinical Disease Activity Index (CDAI) Score Month 6 (n=15)	13.12 units on a scale Standard Deviation 11.55
Clinical Disease Activity Index (CDAI) Score Month 12 (n=10)	6.77 units on a scale Standard Deviation 5.33

SECONDARY outcome

Timeframe: Baseline, Study end (at Month 12 or at time of study discontinuation)

Population: FAS.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants Who Received Tocilizumab as Monotherapy Baseline	2 participants
Number of Participants Who Received Tocilizumab as Monotherapy Study end	9 participants

SECONDARY outcome

Timeframe: Baseline, Study end (at Month 12 or at time of study discontinuation)

Population: FAS.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs) Baseline	21 participants
Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs) Study end	14 participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed at specified time point.

Outcome measures

Measure	Tocilizumab n=23 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants Receiving Oral Corticosteroids Baseline (n=23)	18 Participants
Number of Participants Receiving Oral Corticosteroids Month 3 (n=21)	14 Participants
Number of Participants Receiving Oral Corticosteroids Month 6 (n=19)	12 Participants
Number of Participants Receiving Oral Corticosteroids Month 12 (n=15)	9 Participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.

Participants were assigned the disease activity status on the basis of DAS28 score. Description of DAS28 calculation is provided in Outcome Measure 7. Remission: DAS28 score <= 2.6; low disease activity: DAS28 <=3.2; moderate disease activity: DAS28 <=5.1; and high disease activity: DAS28 >5.1.

Outcome measures

Measure	Tocilizumab n=22 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants With Disease Activity Status Based on DAS28 Score Baseline: Remission (n=22)	1 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Baseline: low disease activity (n=22)	1 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Baseline: moderate disease activity (n=22)	4 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Baseline: high disease activity (n=22)	16 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 3: Remission (n=19)	5 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 3: low disease activity (n=19)	3 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 3: moderate disease activity (n=19)	8 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 3: high disease activity (n=19)	3 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 6: Remission (n=17)	8 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 6: low disease activity (n=17)	3 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 6: moderate disease activity (n=17)	4 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 6: high disease activity (n=17)	2 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 12: Remission (n=11)	9 participants
Number of Participants With Disease Activity Status Based on DAS28 Score Month 12: moderate disease activity (n=11)	2 participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.

Participants were assigned the disease activity status on the basis of SDAI score. Description of SDAI score calculation is provided in Outcome Measure 19. Remission: SDAI score <= 3.3; low disease activity: SDAI <=11.0; moderate disease activity: SDAI <=26.0; and high disease activity: SDAI >26.0.

Outcome measures

Measure	Tocilizumab n=20 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants With Disease Activity Status Based on SDAI Score Baseline: moderate disease activity (n=20)	5 participants
Number of Participants With Disease Activity Status Based on SDAI Score Baseline: high disease activity (n=20)	15 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 3: low disease activity (n=16)	5 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 3: moderate disease activity (n=16)	8 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 3: high disease activity (n=16)	3 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 6: Remission (n=15)	3 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 6: low disease activity (n=15)	4 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 6: moderate disease activity (n=15)	7 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 6: high disease activity (n=15)	1 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 12: Remission (n=10)	2 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 12: low disease activity (n=10)	6 participants
Number of Participants With Disease Activity Status Based on SDAI Score Month 12: moderate disease activity (n=10)	2 participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6, and 12

Population: FAS. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category.

Participants were assigned the disease activity status on the basis of CDAI score. Description of CDAI score calculation is provided in Outcome Measure 20. Remission: CDAI score <= 2.8; low disease activity: CDAI <=10.0; moderate disease activity: CDAI <=22.0; and high disease activity: CDAI >22.0.

Outcome measures

Measure	Tocilizumab n=20 Participants Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Number of Participants With Disease Activity Status Based on CDAI Score Baseline: moderate disease activity (n=20)	5 participants
Number of Participants With Disease Activity Status Based on CDAI Score Baseline: high disease activity (n=20)	15 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 3: low disease activity (n=17)	4 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 3: moderate disease activity (n=17)	9 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 3: high disease activity (n=17)	4 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 6: Remission (n=15)	3 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 6: low disease activity (n=15)	4 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 6: moderate disease activity (n=15)	5 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 6: high disease activity (n=15)	3 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 12: Remission (n=10)	2 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 12: low disease activity (n=10)	6 participants
Number of Participants With Disease Activity Status Based on CDAI Score Month 12: moderate disease activity (n=10)	2 participants

Adverse Events

Tocilizumab

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tocilizumab n=23 participants at risk Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Infections and infestations Chronic tonsillitis	4.3% 1/23 • Up to Month 12
Infections and infestations Post procedural infection	4.3% 1/23 • Up to Month 12
Injury, poisoning and procedural complications Femur fracture	4.3% 1/23 • Up to Month 12
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	4.3% 1/23 • Up to Month 12
Surgical and medical procedures Knee arthroplasty	4.3% 1/23 • Up to Month 12

Other adverse events

Measure	Tocilizumab n=23 participants at risk Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
Blood and lymphatic system disorders Leukopenia	8.7% 2/23 • Up to Month 12
Blood and lymphatic system disorders Neutropenia	8.7% 2/23 • Up to Month 12
Infections and infestations Nasopharyngitis	13.0% 3/23 • Up to Month 12
Infections and infestations Upper respiratory tract infection	8.7% 2/23 • Up to Month 12
Investigations Hepatic enzyme increased	13.0% 3/23 • Up to Month 12
Vascular disorders Hypertension	17.4% 4/23 • Up to Month 12

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

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