Trial Outcomes & Findings for A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy (NCT NCT01705730)

NCT ID: NCT01705730

Last Updated: 2018-09-04

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 71 participants
• Primary outcome timeframe: Month 6 after treatment initiation
• Results posted on: 2018-09-04

Participant Flow

A total of 71 participants were enrolled in the study. Out of 71 participants, 68 received at least one dose of tocilizumab during the study and were included in the full analysis set.

Participant milestones

Measure	Tocilizumab Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Overall Study STARTED	68
Overall Study COMPLETED	59
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Tocilizumab Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Overall Study Lack of Efficacy	1
Overall Study Adverse Event	3
Overall Study Lost to Follow-up	1
Overall Study Reason not Specified	4

Baseline Characteristics

A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy

Baseline characteristics by cohort

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Age, Continuous	59.3 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6 after treatment initiation

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation	79.4 percentage of participants Interval 67.9 to 88.3

SECONDARY outcome

Timeframe: Baseline

Population: Data for this outcome measure was not collected.

Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response DMARD Intolerance	1 participants
Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response Inadequate Response	67 participants

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Number of Participants With Inadequate Response to Other Biologics	35 participants

SECONDARY outcome

Timeframe: Month 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed are the participants who had addition of DMARDs during study.

The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.

Outcome measures

Measure	Tocilizumab n=1 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)	84 days Interval 84.0 to 84.0

SECONDARY outcome

Timeframe: Month 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies those participants who had addition of DMARDs during study.

Outcome measures

Measure	Tocilizumab n=1 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants Who Had DMARDs During Study Hydroxychoroquine	0.0 percentage of participants
Percentage of Participants Who Had DMARDs During Study Sulfasalazine	0.0 percentage of participants
Percentage of Participants Who Had DMARDs During Study Methotrexate	100.0 percentage of participants
Percentage of Participants Who Had DMARDs During Study Leflunomide	0.0 percentage of participants
Percentage of Participants Who Had DMARDs During Study Gold compunds	0.0 percentage of participants
Percentage of Participants Who Had DMARDs During Study Cyclosporine	0.0 percentage of participants
Percentage of Participants Who Had DMARDs During Study Azatioprine	0.0 percentage of participants
Percentage of Participants Who Had DMARDs During Study Other DMARD	0.0 percentage of participants

SECONDARY outcome

Timeframe: 6 months

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Number of Participants With Dose Reductions	4 participants

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Number of Participants With Starting Tocilizumab After Failing DMARDs	33 participants

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents	35 participants

SECONDARY outcome

Timeframe: Month 6

Population: Data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study.

Number of dose modification per participant at Month 6 was reported.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Number of Dose Modifications Per Participant at Month 6	0.1 number of dose modifications Standard Deviation 0.2

SECONDARY outcome

Timeframe: Month 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Analysis was performed only participants reaching 6 month visit.

Outcome measures

Measure	Tocilizumab n=54 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Mean Dosing Interval Per Participant at Month 6	25.86 days Standard Deviation 2.64

SECONDARY outcome

Timeframe: Month 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies the participants who were evaluable for the outcome measure.

Outcome measures

Measure	Tocilizumab n=13 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy Lack of efficacy	7.7 percentage of participants
Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy Adverse Event	61.5 percentage of participants
Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy Other	30.8 percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, number of participants analyzed signifies number of participants evaluated for this outcome measure.

Outcome measures

Measure	Tocilizumab n=4 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Time for Restoration of Initial Dosing Regimen	NA days Median and full range could not be reached as less than 50% of the participants restored to initial dosing regimen.

SECONDARY outcome

Timeframe: Month 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen	20.6 percentage of participants Interval 11.7 to 32.1

SECONDARY outcome

Timeframe: Month 6

Population: Only participants experiencing 'adverse events and/or abnormal laboratory tests requiring modification of drug dosage' are taken into account for this analysis.

Outcome measures

Measure	Tocilizumab n=8 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Number of Participants Who Were Not Adhering to Recommended Management of AEs	0 participants

SECONDARY outcome

Timeframe: Month 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants Still on Tocilizumab Monotherapy at Month 6	98.1 percentage of participants Interval 90.0 to 99.9

SECONDARY outcome

Timeframe: Baseline

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants With Reason for Choice of Monotherapy at Baseline MTX Intolerance	61.8 percentage of participants
Percentage of Participants With Reason for Choice of Monotherapy at Baseline Continued MTX not Appropriate	38.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

TJC was determined by examining 28 and 68 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, tenderness = 1.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Tender Joint Count (TJC) Baseline for TJC28 (n=47)	10.3 tender joints Standard Deviation 6.0
Tender Joint Count (TJC) Month 3 for TJC28 (n=29)	2.9 tender joints Standard Deviation 5.0
Tender Joint Count (TJC) Month 6 for TJC 28 (n=17)	2.2 tender joints Standard Deviation 3.3
Tender Joint Count (TJC) Baseline for TJC68 (n=7)	8.6 tender joints Standard Deviation 3.2
Tender Joint Count (TJC) Month 3 for TJC68 (n=10)	2.0 tender joints Standard Deviation 2.7
Tender Joint Count (TJC) Month 6 for TJC68 (n=1)	0.0 tender joints Standard Deviation NA Standard deviation was not estimable for TJC68 as only 1 participant was evaluated at Month 6.

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Swollen Joint Count (SJC) Baseline for SJC28 (n=47)	7.9 swollen joints Standard Deviation 5.6
Swollen Joint Count (SJC) Month 3 for SJC28 (n=29)	1.5 swollen joints Standard Deviation 3.5
Swollen Joint Count (SJC) Month 6 for SJC 28 (n=17)	0.9 swollen joints Standard Deviation 1.4
Swollen Joint Count (SJC) Baseline for SJC66 (n=7)	8.9 swollen joints Standard Deviation 4.5
Swollen Joint Count (SJC) Month 3 for SJC66 (n=10)	0.6 swollen joints Standard Deviation 1.3
Swollen Joint Count (SJC) Month 6 for SJC66 (n=1)	0.0 swollen joints Standard Deviation NA Standard deviation was not estimable for SJC66 as 1 participant was evaluated at Month 6.

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants With Disease Activity Score-28 (DAS28) LDA at Baseline (n=38)	0 percentage of participants
Percentage of Participants With Disease Activity Score-28 (DAS28) LDA at Month 3 (n=19)	73.7 percentage of participants
Percentage of Participants With Disease Activity Score-28 (DAS28) LDA at Month 6 (n=11)	81.8 percentage of participants
Percentage of Participants With Disease Activity Score-28 (DAS28) Remission at Baseline (n=38)	0 percentage of participants
Percentage of Participants With Disease Activity Score-28 (DAS28) Remission at Month 3 (n=19)	68.4 percentage of participants
Percentage of Participants With Disease Activity Score-28 (DAS28) Remission at Month 6 (n=11)	81.8 percentage of participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 Month 3 (n=10)	90 percentage of participants
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 Month 6 (n=5)	80 percentage of participants

SECONDARY outcome

Timeframe: Month 3, 6

Population: The ACR analysis was not performed because the Health Assessment Questionnaire (HAQ) disability index score is needed; only HAQ total score expressed in % was available.

ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response Remission at Month 6 (n=4)	75.0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response Baseline LDA (n=30)	13.3 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response LDA at Month 3 (n=8)	25.0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response LDA at Month 6 (n=4)	25.0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response Baseline Moderate Disease Activity (n=30)	50.0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response Moderate Disease Activity at Month 3 (n=8)	0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response Baseline Remission (n=30)	0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response Remission at Month 3 (n=8)	75.0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response Moderate Disease Activity at Month 6 (n=4)	0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response Baseline High Disease Activity (n=30)	36.7 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response High Disease Activity at Month 3 (n=8)	0 percentage of participants
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response High Disease Activity at Month 6 (n=4)	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response Baseline Remission (n=28)	0 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response Remission at Month 3 (n=8)	75.0 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response Remission at Month 6 (n=4)	75.0 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response Baseline LDA (n=28)	17.9 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response LDA at Month 3 (n=8)	25.0 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response LDA at Month 6 (n=4)	25.0 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response Baseline Moderate Disease Activity (n=28)	46.4 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response Moderate Disease Activity at Month 3 (n=8)	0 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response Moderate Disease Activity at Month 6 (n=4)	0 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response Baseline High Disease Activity (n=28)	35.7 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response High Disease Activity at Month 3 (n=8)	0 percentage of participants
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response High Disease Activity at Month 6 (n=4)	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 Baseline (n=40)	65.6 units on a scale Standard Deviation 15.2
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 Change at Month 3 (n=12)	-27.8 units on a scale Standard Deviation 27.5
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 Change at Month 6 (n=7)	-30.1 units on a scale Standard Deviation 16.2

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 Baseline (n=34)	57.6 units on a scale Standard Deviation 23.1
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 Change at Month (n=9)	-41.9 units on a scale Standard Deviation 22.6
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 Change at Month (n=3)	-53.0 units on a scale Standard Deviation 20.7

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

The HAQ was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6 Baseline (n=42)	41.11 units on a scale Standard Deviation 19.40
Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6 Change at Month 3 (n=13)	-23.59 units on a scale Standard Deviation 29.09
Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6 Change at Month 6 (n=6)	-11.94 units on a scale Standard Deviation 19.87

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Change From Baseline in VAS-Fatigue at Month 3 and Month 6 Baseline (n=31)	64 units on a scale Standard Deviation 16.5
Change From Baseline in VAS-Fatigue at Month 3 and Month 6 Change at Month 3 (n=9)	-19.3 units on a scale Standard Deviation 18.4
Change From Baseline in VAS-Fatigue at Month 3 and Month 6 Change at Month 6 (n=5)	-38.4 units on a scale Standard Deviation 21.4

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 Baseline (n=34)	60.6 units on a scale Standard Deviation 22.9
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 Change at Month 3 (n=9)	-31.8 units on a scale Standard Deviation 25.1
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 Change at Month 6 (n=4)	-33.0 units on a scale Standard Deviation 18.2

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

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 as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6 Baseline (n=22)	37.8 units on a scale Standard Deviation 22.9
Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6 Change at Month 3 (n=5)	-7.6 units on a scale Standard Deviation 26.3
Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6 Change at Month 6 (n=3)	-30.3 units on a scale Standard Deviation 18.5

SECONDARY outcome

Timeframe: Month 6

Population: Safety population included all participants that received a dose of study drug.

An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) AE	61.8 percentage of participants
Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) SAE	4.4 percentage of participants
Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) AESI	8.8 percentage of participants

SECONDARY outcome

Timeframe: Month 6

Population: Safety population included all participants that received a dose of study drug.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Percentage of Participants With AEs Leading to Dose Modifications	7.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

CRP is an acute phase reactant and is a measure of inflammation.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
C-reactive Protein (CRP]) Level Baseline (n= 51)	9.94 milligram per liter (mg/L) Standard Deviation 20.71
C-reactive Protein (CRP]) Level Month 3 (n= 52)	5.04 milligram per liter (mg/L) Standard Deviation 18.95
C-reactive Protein (CRP]) Level Month 6 (n= 28)	2.49 milligram per liter (mg/L) Standard Deviation 3.16

SECONDARY outcome

Timeframe: Baseline, Month 3, 6

Population: Full analysis set included all participants that received at least one dose of tocilizumab during the study. Here, n signifies the number of participants who were evaluated for the specified time points.

ESR is an acute phase reactant and is a measure of inflammation.

Outcome measures

Measure	Tocilizumab n=68 Participants Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Erythrocyte Sedimentation Rate (ESR) Level Baseline (n= 42)	24.31 millimeter per hour (mm/hr) Standard Deviation 24.68
Erythrocyte Sedimentation Rate (ESR) Level Month 3 (n= 38)	12.71 millimeter per hour (mm/hr) Standard Deviation 23.84
Erythrocyte Sedimentation Rate (ESR) Level Month 6 (n= 17)	8.88 millimeter per hour (mm/hr) Standard Deviation 15.07

Adverse Events

Tocilizumab

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tocilizumab n=68 participants at risk Participants with RA received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Immune system disorders Sarcoidosis	1.5% 1/68 • Month 6 An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Psychiatric disorders Depression	1.5% 1/68 • Month 6 An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
Vascular disorders Infarction	1.5% 1/68 • Month 6 An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 1-800-821-8590

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