Trial Outcomes & Findings for A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis (NCT NCT01562327)

NCT ID: NCT01562327

Last Updated: 2016-11-29

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: 6 months after treatment initiation
• Results posted on: 2016-11-29

Participant Flow

Participant milestones

Measure	Tocilizumab Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
Overall Study STARTED	50
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Tocilizumab Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
Overall Study Adverse Event	2
Overall Study Lack of Efficacy	1
Overall Study Participant drop-out	1
Overall Study Infusion not received at 6 month window	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tocilizumab n=50 Participants Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
Age, Continuous	53.9 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after treatment initiation

Population: The Full Analysis Set (FAS) was defined as all participants who received at least one dose of Tocilizumab.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation	84 percentage of participants Interval 71.0 to 93.0

SECONDARY outcome

Timeframe: Baseline

Population: FAS was defined as all participants who received at least one dose of Tocilizumab.

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 one of the conditions.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants With Systemic Manifestations of RA at Baseline	40 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS was defined as all participants who received at least one dose of Tocilizumab.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab	5 participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS was defined as all participants who received at least one dose of Tocilizumab.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants Who Previously Received DMARDs 0 DMARDs	48.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 1 DMARD	24.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 2 DMARDs	14.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 3 DMARDs	10.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 4 DMARDs	0.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 5 DMARDs	1 percentage of participants
Percentage of Participants Who Previously Received DMARDs 6 DMARDs	2.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 7 DMARDs	0.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 8 DMARDs	0.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 9 DMARDs	0.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 10 DMARDs	0.00 percentage of participants
Percentage of Participants Who Previously Received DMARDs 11 DMARDs	2.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.

Outcome measures

Measure	Tocilizumab n=5 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Reason for DMARDs Withdrawal at Baseline Adverse event	2 participants
Reason for DMARDs Withdrawal at Baseline Unknown	2 participants
Reason for DMARDs Withdrawal at Baseline Other - reason not specified	1 participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS was defined as all participants who received at least one dose of Tocilizumab.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab	19 participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS was defined as all participants who received at least one dose of Tocilizumab.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants Who Previously Received Biologic Agents 0 Biologic Agents	62.00 percentage of participants
Percentage of Participants Who Previously Received Biologic Agents 1 Biologic Agent	16.00 percentage of participants
Percentage of Participants Who Previously Received Biologic Agents 2 Biologic Agents	16.00 percentage of participants
Percentage of Participants Who Previously Received Biologic Agents 3 Biologic Agents	4.00 percentage of participants
Percentage of Participants Who Previously Received Biologic Agents 4 Biologic Agents	2.00 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: FAS defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.

Outcome measures

Measure	Tocilizumab n=19 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Reason for Biologic Agent Withdrawal at Baseline Lack of efficacy	13 participants
Reason for Biologic Agent Withdrawal at Baseline Adverse event	1 participants
Reason for Biologic Agent Withdrawal at Baseline Other - reason not specified	2 participants
Reason for Biologic Agent Withdrawal at Baseline Unknown	3 participants

SECONDARY outcome

Timeframe: approximately 3 years

Population: FAS was defined as all participants who received at least one dose of Tocilizumab.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Reasons for Dose Modifications Adverse Event	1 participants
Reasons for Dose Modifications Other	21 participants

SECONDARY outcome

Timeframe: Approximately 3 years

Population: FAS was defined as all participants who received at least one dose of Tocilizumab.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy Adverse Event	4 percentage of participants
Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy Lack of Efficacy	2 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab.

Percentage of participants on Tocilizumab as monotherapy or combination therapy (with DMARDs) were reported at start of treatment and at 6 months from the start of treatment.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy Monotherapy at baseline	14 percentage of participants
Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy With DMARDs at baseline	86 percentage of participants
Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy Monotherapy at Month 6	14 percentage of participants
Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy With DMARDs at Month 6	86 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.

The number of tender joints was recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 28 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A decrease in score indicated improvement.

Outcome measures

Measure	Tocilizumab n=29 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6 Baseline (n=29)	12 units on a scale Interval 2.0 to 28.0
Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6 Change at Month 3 (n=22)	-6 units on a scale Interval -25.0 to 4.0
Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6 Change at Month 6 (n=22)	-9 units on a scale Interval -22.0 to 4.0

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.

The number of swollen joints was recorded on the joint assessment form, no swelling = 0, swelling =1, for 28 joints and were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A decrease in score indicates improvement.

Outcome measures

Measure	Tocilizumab n=29 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6 Baseline (n=29)	8 units on a scale Interval 1.0 to 17.0
Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6 Change at Month 3 (n=22)	-5 units on a scale Interval -16.0 to 4.0
Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6 Change at Month 6 (n=22)	-7.50 units on a scale Interval -17.0 to 6.0

SECONDARY outcome

Timeframe: Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.

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=4 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 < 2.6 Clinical Remission at Month 3 (n=2)	0 participants
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 <2.6 Clinical Remission at Month 6 (n=4)	0 participants
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 >=2.6-<=3.2 Low Disease Activity at Month 3 (n=2)	0 participants
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 >=2.6-<=3.2 Low Disease Activity at Month 6 (n=4)	3 participants
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 >3.2-<=5.1 Moderate Disease at Month 3(n=2)	2 participants
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 >3.2-<=5.1 Moderate Disease at Month 6 (n=4)	1 participants
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 >5.1 High Disease Activity at Month 3 (n=2)	0 participants
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 >5.1 High Disease Activity at Month 6 (n=4)	0 participants

SECONDARY outcome

Timeframe: Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure.

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=23 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 <= 2.8 Clinical remission at Month 3	1 participants
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 <= 2.8 Clinical remission at Month 6	2 participants
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 > 2.8 and <= 10.0 Low disease activity at Month 3	7 participants
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 > 2.8 and <= 10.0 Low disease activity at Month 6	7 participants
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 > 10.0 and <= 22.0 Moderate activity at Month 3	6 participants
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 > 10.0 and <= 22.0 Moderate activity at Month 6	9 participants
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 > 22.0 High disease activity at Month 3	9 participants
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 > 22.0 High disease activity at Month 6	5 participants

SECONDARY outcome

Timeframe: Month 3, Month 6

Population: Data was not collected, hence not reported.

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

Outcome data not reported

SECONDARY outcome

Timeframe: Month 3, Month 6

Population: Data was not collected, hence not reported.

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. 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. 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Number of participants analyzed signifies the participants who were evaluable for this outcome measure. Here, 'n' represents the number of participants with a measure at the specified time point.

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

Measure	Tocilizumab n=22 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 ACR 20 at Month 3 (n=21)	38.10 percentage of participants
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 ACR 20 at Month 6 (n=22)	68.18 percentage of participants
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 ACR 50 at Month 3 (n=21)	23.81 percentage of participants
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 ACR 50 at Month 6 (n=22)	40.91 percentage of participants
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 ACR 70 at Month 3 (n=21)	14.29 percentage of participants
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 ACR 70 at Month 6 (n=22)	13.64 percentage of participants
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 ACR 90 at Month 3 (n=21)	0.00 percentage of participants
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 ACR 90 at Month 6 (n=22)	9.09 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.

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=35 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 Baseline (n=35)	51 units on a scale Interval 5.0 to 90.0
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 Change at Month 3 (n=29)	-10 units on a scale Interval -85.0 to 31.0
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 Change at Month 6 (n=27)	-20 units on a scale Interval -87.0 to 0.0

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.

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=39 Participants Participants with moderate to severe RA received Tocilizumab 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=39)	65 units on a scale Interval 5.0 to 100.0
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 Change at Month 3 (n=31)	-10 units on a scale Interval -85.0 to 40.0
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 Change at Month 6 (n=30)	-15 units on a scale Interval -86.0 to 20.0

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measure at the specified time point.

The HAQ-DI 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-DI 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=33 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) < 0.5 Clinical Remission at Baseline (n=33)	6.06 percentage of participants
Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) >= 0.5 No remission at Baseline (n=33)	93.94 percentage of participants
Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) < 0.5 Clinical Remission at Month 3 (n=25)	40.00 percentage of participants
Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) >= 0.5 No remission at Month 3 (n=25)	60.00 percentage of participants
Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) < 0.5 Clinical Remission at Month 6 (n=26)	26.92 percentage of participants
Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) >= 0.5 No remission at Month 6 (n=26)	73.08 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.

The Patient Global Assessment of 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=28 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6 Baseline (n=28)	70 units on a scale Interval 0.0 to 100.0
Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6 Change at Month 3 (n=23)	-35 units on a scale Interval -100.0 to 38.0
Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6 Change at Month 6 (n=22)	-30 units on a scale Interval -90.0 to 70.0

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.

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=37 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 Baseline (n=37)	80 units on a scale Interval 15.0 to 100.0
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 Change at Month 3 (n=30)	-23 units on a scale Interval -100.0 to 27.0
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 Change at Month 6 (n=29)	-25 units on a scale Interval -95.0 to 24.0

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Population: FAS was defined as all participants who received at least one dose of Tocilizumab. Here, 'n' represents the number of participants with a measurement at the specified time point.

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=21 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6 Baseline (n=21)	60 units on a scale Interval 0.0 to 100.0
Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6 Change at Month 3 (n=16)	-50 units on a scale Interval -100.0 to 60.0
Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6 Change at Month 6 (n=14)	-25 units on a scale Interval -87.0 to 10.0

SECONDARY outcome

Timeframe: approximately 3 years

Population: Safety population was defined as all participants who received at least one dose of Tocilizumab.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.

Outcome measures

Measure	Tocilizumab n=50 Participants Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Percentage of Participants With an Adverse Event (AE)	56.00 percentage of participants

Adverse Events

Tocilizumab

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tocilizumab n=50 participants at risk Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
Injury, poisoning and procedural complications Femur fracture	2.0% 1/50 • Approximately 3 years An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.
Cardiac disorders Angina unstable	2.0% 1/50 • Approximately 3 years An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug.

Other adverse events

Adverse event data not reported

Additional Information

Medical Communications

Hoffmann-La Roche

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