Trial Outcomes & Findings for TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF (NCT NCT00977106)

Last Updated: 2014-09-22

Results Overview

HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3. Relevant clinical improvement was defined as a reduction of at least 0.22 points in HAQ-DI.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

103 participants

Primary outcome timeframe

Week 4

Results posted on

2014-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo, Tocilizumab Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) intravenously (IV) during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 milligrams per kilogram (mg/kg; 800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Overall Study STARTED	47	56
Overall Study COMPLETED	37	45
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Tocilizumab Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) intravenously (IV) during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 milligrams per kilogram (mg/kg; 800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Overall Study Adverse Event	5	6
Overall Study Withdrawal by Subject	2	2
Overall Study Lack of Efficacy	2	2
Overall Study Protocol Violation	0	1
Overall Study Other	1	0

Baseline Characteristics

TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.	Total n=103 Participants Total of all reporting groups
Age, Continuous	51.3 years STANDARD_DEVIATION 11.8 • n=5 Participants	52.8 years STANDARD_DEVIATION 11.6 • n=7 Participants	52.0 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	41 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: ITT Population

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percentage of Participants With Clinically Significant Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 4	42.0 percentage of participants	49.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 1 and 4

Population: ITT Population; number (n) = number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Participants were asked to rate their assessment of disease activity using a visual analog scale (VAS) of 0 to 100 millimeters (mm), where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period Baseline (n=50,53)	58.8 mm Standard Deviation 21.1	64.3 mm Standard Deviation 17.4
Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period Week 1 (n=42,42)	49.0 mm Standard Deviation 23.2	54.2 mm Standard Deviation 20.6
Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period Change at Week 1 (n=42,42)	-11.0 mm Standard Deviation 19.7	-7.4 mm Standard Deviation 17.8
Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period Week 4 (n=45,51)	49.2 mm Standard Deviation 24.0	51.1 mm Standard Deviation 22.7
Patient Global Assessment of Disease Activity During the Double-Blind Treatment Period Change at Week 4 (n=45,51)	-14.3 mm Standard Deviation 23.6	-9.6 mm Standard Deviation 17.4

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36 and 48

Population: ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Participants were asked to rate their assessment of disease activity using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=47 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=56 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Patient Global Assessment of Disease Activity During the Open Treatment Period Baseline (n=46,56)	51.2 mm Standard Deviation 22.9	59.4 mm Standard Deviation 21.1
Patient Global Assessment of Disease Activity During the Open Treatment Period Week 12 (n=45,51)	36.0 mm Standard Deviation 23.8	32.7 mm Standard Deviation 24.7
Patient Global Assessment of Disease Activity During the Open Treatment Period Change at Week 12 (n=44,51)	-16.2 mm Standard Deviation 27.6	-26.7 mm Standard Deviation 24.2
Patient Global Assessment of Disease Activity During the Open Treatment Period Week 24 (n=438,48)	27.4 mm Standard Deviation 21.7	31.4 mm Standard Deviation 25.9
Patient Global Assessment of Disease Activity During the Open Treatment Period Change at Week 24 (n=42,48)	-25.3 mm Standard Deviation 28.5	-27.2 mm Standard Deviation 24.5
Patient Global Assessment of Disease Activity During the Open Treatment Period Week 36 (n=39,46)	25.7 mm Standard Deviation 18.1	28.7 mm Standard Deviation 24.5
Patient Global Assessment of Disease Activity During the Open Treatment Period Change at Week 36 (n=38,46)	-24.2 mm Standard Deviation 27.8	-29.7 mm Standard Deviation 25.9
Patient Global Assessment of Disease Activity During the Open Treatment Period Week 48 (n=36,45)	25.6 mm Standard Deviation 24.4	26.6 mm Standard Deviation 23.2
Patient Global Assessment of Disease Activity During the Open Treatment Period Change at Week 48 (n=35,45)	-24.9 mm Standard Deviation 28.5	-31.7 mm Standard Deviation 23.3

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Physicians were asked to assess disease activity of the participants using a VAS of 0 to 100 mm, where 0 represented no symptoms and 100 represented severe symptoms. Physicians were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period Baseline (n=50,53)	60.8 mm Standard Deviation 17.2	58.4 mm Standard Deviation 15.3
Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period Week 4 (n=50,52)	49.2 mm Standard Deviation 18.1	44.6 mm Standard Deviation 22.5
Physician Global Assessment of Disease Activity During the Double-Blind Treatment Period Change at Week 4 (n=50,52)	-11.6 mm Standard Deviation 19.3	-14.3 mm Standard Deviation 20.7

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36, and 48

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=47 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=56 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Physician Global Assessment of Disease Activity During the Open Treatment Period Baseline (n=47,56)	49.3 mm Standard Deviation 18.6	59.6 mm Standard Deviation 16.3
Physician Global Assessment of Disease Activity During the Open Treatment Period Week 12 (n=44,51)	32.9 mm Standard Deviation 20.4	28.3 mm Standard Deviation 21.7
Physician Global Assessment of Disease Activity During the Open Treatment Period Change at Week 12 (n=44,51)	-16.5 mm Standard Deviation 23.9	-30.8 mm Standard Deviation 21.7
Physician Global Assessment of Disease Activity During the Open Treatment Period Week 24 (n=42,50)	24.3 mm Standard Deviation 17.0	24.7 mm Standard Deviation 21.1
Physician Global Assessment of Disease Activity During the Open Treatment Period Change at Week 24 (n=42,50)	-27.4 mm Standard Deviation 21.3	-34.9 mm Standard Deviation 21.3
Physician Global Assessment of Disease Activity During the Open Treatment Period Week 36 (n=38,46)	22.7 mm Standard Deviation 16.5	23.1 mm Standard Deviation 20.6
Physician Global Assessment of Disease Activity During the Open Treatment Period Change at Week 36 (n=38,46)	-28.4 mm Standard Deviation 20.7	-34.9 mm Standard Deviation 23.1
Physician Global Assessment of Disease Activity During the Open Treatment Period Week 48 (n=37,44)	16.4 mm Standard Deviation 15.8	19.3 mm Standard Deviation 18.2
Physician Global Assessment of Disease Activity During the Open Treatment Period Change at Week 48 (n=37,44)	-35.0 mm Standard Deviation 23.0	-39.4 mm Standard Deviation 19.7

SECONDARY outcome

Timeframe: Baseline and Week 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Participants were asked to rate their assessment of pain using a VAS of 0 to 100 mm, where 0 represented no pain and 100 represented intolerable pain. Participants were asked to mark the line corresponding to their assessment and the distance from the left edge was measured. A negative value in change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Patient Global Assessment of Pain During the Double-Blind Treatment Period Baseline (n=49,51)	60.2 mm Standard Deviation 20.0	54.6 mm Standard Deviation 21.8
Patient Global Assessment of Pain During the Double-Blind Treatment Period Week 4 (n=49,53)	49.1 mm Standard Deviation 24.6	46.4 mm Standard Deviation 27.0
Patient Global Assessment of Pain During the Double-Blind Treatment Period Change at Week 4 (n=49,51)	-11.1 mm Standard Deviation 25.6	-7.3 mm Standard Deviation 22.8

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 48

Population: ITT Population; 3 participants were randomized to the placebo treatment group but received tocilizumab. n=number of participants assessed at a specific visit

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=47 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=56 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Patient Global Assessment of Pain During the Open Treatment Period Change at Week 36 (n=38,45)	-25.6 mm Standard Deviation 31.0	-28.3 mm Standard Deviation 27.4
Patient Global Assessment of Pain During the Open Treatment Period Baseline (n=46,54)	48.9 mm Standard Deviation 24.5	55.1 mm Standard Deviation 22.2
Patient Global Assessment of Pain During the Open Treatment Period Week 12 (n=45,51)	29.6 mm Standard Deviation 23.9	32.8 mm Standard Deviation 24.0
Patient Global Assessment of Pain During the Open Treatment Period Change at Week 12 (n=44,50)	-20.3 mm Standard Deviation 27.6	-22.2 mm Standard Deviation 26.2
Patient Global Assessment of Pain During the Open Treatment Period Week 24 (n=43,50)	26.2 mm Standard Deviation 21.3	27.7 mm Standard Deviation 25.2
Patient Global Assessment of Pain During the Open Treatment Period Change at Week 24 (n=42,49)	-25.0 mm Standard Deviation 29.2	-25.9 mm Standard Deviation 22.0
Patient Global Assessment of Pain During the Open Treatment Period Week 36 (n=39,46)	23.1 mm Standard Deviation 17.2	25.0 mm Standard Deviation 21.3
Patient Global Assessment of Pain During the Open Treatment Period Week 48 (n=36,45)	22.1 mm Standard Deviation 22.9	23.0 mm Standard Deviation 20.4
Patient Global Assessment of Pain During the Open Treatment Period Change at Week 48 (n=35,44)	-28.0 mm Standard Deviation 29.7	-30.4 mm Standard Deviation 25.8

SECONDARY outcome

Timeframe: Baseline, Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 metacarpal phalangeal \[MCP; left and right\] joints, 5 proximal interphalangeal \[PIP; left and right\] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 metatarsal phalangeal \[MTP; left and right\] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120. A score of 0 indicated no damage and a score of 120 indicated most severe damage. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. A negative change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound Baseline (n=50,53)	26.4 units on a scale Standard Deviation 17.2	25.8 units on a scale Standard Deviation 16.8
Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound Week 1 (n=49,53)	26.4 units on a scale Standard Deviation 19.1	25.3 units on a scale Standard Deviation 17.6
Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound Change at Week 1 (n=49,53)	-0.1 units on a scale Standard Deviation 7.1	-0.6 units on a scale Standard Deviation 7.1
Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound Week 4 (n=48,52)	26.3 units on a scale Standard Deviation 18.9	21.8 units on a scale Standard Deviation 15.5
Synovitis Score During the Double-Blind Treatment Period Assessed Using B-Mode Ultrasound Change at Week 4 (n=48,52)	0.8 units on a scale Standard Deviation 7.8	-4.4 units on a scale Standard Deviation 10.0

SECONDARY outcome

Timeframe: Baseline, Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP \[left and right\] joints, 5 PIP \[left and right\] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP \[left and right\] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Negative change from baseline indicated improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound Baseline (n=50,53)	10.1 units on a scale Standard Deviation 11.2	10.2 units on a scale Standard Deviation 11.4
Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound Week 1 (n=49,53)	9.6 units on a scale Standard Deviation 11.9	8.9 units on a scale Standard Deviation 12.3
Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound Change at Week 1 (n=49,53)	-0.3 units on a scale Standard Deviation 3.5	-1.4 units on a scale Standard Deviation 4.9
Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound Week 4 (n=48,52)	10.0 units on a scale Standard Deviation 13.2	8.4 units on a scale Standard Deviation 12.1
Synovitis Score During the Double-Blind Treatment Period Assessed Using Power Doppler Ultrasound Change at Week 4 (n=48,52)	0.8 units on a scale Standard Deviation 7.7	-2.0 units on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: Weeks 12, 24, and 48

Population: One-Year Efficacy Population: all randomized participants with at least 1 tocilizumab infusion (completed or not). n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP \[left and right\] joints, 5 PIP \[left and right\] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP \[left and right\] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage (%) change from baseline.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=94 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound Week 12 (n=94)	-15.0 percent change Standard Deviation 81.9	—
Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound Week 24 (n=87)	-30.5 percent change Standard Deviation 64.4	—
Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using B-Mode Ultrasound Week 48 (n=77)	-43.7 percent change Standard Deviation 67.0	—

SECONDARY outcome

Timeframe: Weeks 12, 24, and 48

Synovitis was assessed by ultrasonography (B-mode ultrasound and Power Doppler) and scored from "0" to "3", for each of 40 joints (5 MCP \[left and right\] joints, 5 PIP \[left and right\] joints, left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP \[left and right\] joints); synovitis scores were calculated by adding the sum of scores for each joint for a total score ranging from 0 to 120 (higher score=more severe disease). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4. Relative change was the percentage change from baseline.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=94 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound Week 12 (n=94)	121.0 percent change Standard Deviation 573.0	—
Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound Week 24 (n=87)	-23.5 percent change Standard Deviation 92.8	—
Percent Change From Baseline in Synovitis Score During the Open Treatment Period Assessed Using Power Doppler Ultrasound Week 48 (n=77)	3.6 percent change Standard Deviation 263.2	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm per hour (mm/hr). A reduction in ESR indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period Baseline (n=50,53)	27.5 mm/hr Standard Deviation 22.9	28.1 mm/hr Standard Deviation 25.6
Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period Week 1 (n=49,51)	27.6 mm/hr Standard Deviation 24.2	11.9 mm/hr Standard Deviation 12.7
Erythrocyte Sedimentation Rate During the Double-Blind Treatment Period Week 4 (n=50,51)	26.6 mm/hr Standard Deviation 19.9	8.2 mm/hr Standard Deviation 11.0

SECONDARY outcome

Timeframe: Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Erythrocyte sedimentation rate is a biological marker of inflammation. A negative change indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=49 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment Week 1 (n=49,53)	8.7 percent change Standard Deviation 56.4	-51.2 percent change Standard Deviation 32.8
Percent Change From Baseline in Erythrocyte Sedimentation Rate During the Double-Blind Treatment Week 4 (n=48,52)	11.5 percent change Standard Deviation 64.1	-65.9 percent change Standard Deviation 28.4

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Erythrocyte sedimentation rate is a biological marker of inflammation, measured in mm/hr. A reduction in ESR indicates improvement. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Erythrocyte Sedimentation Rate During the Open Treatment Period Baseline (n=103)	27.8 mm/hr Standard Deviation 22.8	—
Erythrocyte Sedimentation Rate During the Open Treatment Period Week 12 (n=96)	6.8 mm/hr Standard Deviation 11.4	—
Erythrocyte Sedimentation Rate During the Open Treatment Period Week 24 (n=92)	5.9 mm/hr Standard Deviation 6.1	—
Erythrocyte Sedimentation Rate During the Open Treatment Period Week 36 (n=84)	8.0 mm/hr Standard Deviation 13.4	—
Erythrocyte Sedimentation Rate During the Open Treatment Period Week 48 (n=80)	4.6 mm/hr Standard Deviation 3.5	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

C-Reactive protein (CRP) is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). A reduction in CRP indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=48 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
C-Reactive Protein During the Double-Blind Treatment Period Baseline (n=47,53)	18.6 ng/mL Standard Deviation 23.6	14.2 ng/mL Standard Deviation 21.8
C-Reactive Protein During the Double-Blind Treatment Period Week 1 (n=47,52)	20.4 ng/mL Standard Deviation 34.3	2.3 ng/mL Standard Deviation 2.0
C-Reactive Protein During the Double-Blind Treatment Period Week 4 (n=48,52)	17.5 ng/mL Standard Deviation 21.8	3.8 ng/mL Standard Deviation 9.4

SECONDARY outcome

Timeframe: Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

C-Reactive protein (CRP) is a biological marker of inflammation. Negative changes from baseline indicate improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=46 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=52 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period Week 1 (n=44,52)	19.2 percent change Standard Deviation 70.1	-66.2 percent change Standard Deviation 31.8
Percent Change From Baseline in C-Reactive Protein During the Double-Blind Treatment Period Week 4 (n=46,52)	18.3 percent change Standard Deviation 95.6	-47.0 percent change Standard Deviation 95.9

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

C-reactive protein is a biological marker of inflammation and is measured in nanograms per milliliter (ng/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=102 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
C- Reactive Protein During the Open Treatment Period Baseline (n=102)	15.8 ng/L Standard Deviation 20.8	—
C- Reactive Protein During the Open Treatment Period Week 12 (n=95)	3.9 ng/L Standard Deviation 9.7	—
C- Reactive Protein During the Open Treatment Period Week 24 (n=92)	3.2 ng/L Standard Deviation 5.2	—
C- Reactive Protein During the Open Treatment Period Week 36 (n=80)	3.9 ng/L Standard Deviation 6.6	—
C- Reactive Protein During the Open Treatment Period Week 48 (n=81)	2.6 ng/L Standard Deviation 2.6	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Serum Amyloid A (SAA) component is a biological marker of inflammation and is measured in mg/L. A reduction in SAA indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=26 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=29 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Serum Amyloid A Component During the Double-Blind Treatment Period Baseline (n=23,32)	72.0 mg/L Standard Deviation 221.9	57.9 mg/L Standard Deviation 108.2
Serum Amyloid A Component During the Double-Blind Treatment Period Week 1 (n=26,29)	89.5 mg/L Standard Deviation 271.2	6.7 mg/L Standard Deviation 3.6
Serum Amyloid A Component During the Double-Blind Treatment Period Week 4 (n=25,27)	61.2 mg/L Standard Deviation 169.2	8.9 mg/L Standard Deviation 10.4

SECONDARY outcome

Timeframe: Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Serum Amyloid A (SAA) component is a biological marker of inflammation. A negative change from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=22 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=28 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period Week 1 (n=22,28)	59.5 percent change Standard Deviation 247.9	-41.2 percent change Standard Deviation 61.3
Percent Change From Baseline in Serum Amyloid A Component During the Double-Blind Treatment Period Week 4 (n=21,26)	-5.8 percent change Standard Deviation 39.3	-35.5 percent change Standard Deviation 61.0

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Serum Amyloid A (SAA) component is a biological marker of inflammation measured in mg/L. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=58 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Serum Amyloid A Component During the Open Treatment Period Baseline (n=58)	58.6 mg/L Standard Deviation 135.9	—
Serum Amyloid A Component During the Open Treatment Period Week 12 (n=46)	40.3 mg/L Standard Deviation 218.7	—
Serum Amyloid A Component During the Open Treatment Period Week 24 (n=46)	13.3 mg/L Standard Deviation 41.6	—
Serum Amyloid A Component During the Open Treatment Period Week 36 (n=38)	7.3 mg/L Standard Deviation 6.3	—
Serum Amyloid A Component During the Open Treatment Period Week 48 (n=37)	5.7 mg/L Standard Deviation 3.0	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population;n=number of participants assessed for the specified parameter at a given visit.

Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL). Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=96 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Beta 2 Microglobulin Levels During the Open Treatment Period Baseline (n=96)	2.0 mcg/mL Standard Deviation 0.6	—
Beta 2 Microglobulin Levels During the Open Treatment Period Week 12 (n=87)	2.0 mcg/mL Standard Deviation 0.6	—
Beta 2 Microglobulin Levels During the Open Treatment Period Week 24 (n=78)	1.9 mcg/mL Standard Deviation 0.6	—
Beta 2 Microglobulin Levels During the Open Treatment Period Week 36 (n=69)	2.0 mcg/mL Standard Deviation 0.5	—
Beta 2 Microglobulin Levels During the Open Treatment Period Week 48 (n=64)	1.9 mcg/mL Standard Deviation 0.5	—

SECONDARY outcome

Timeframe: Baseline, Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Beta 2 Microglobulin is a biological marker of inflammation measured in micrograms per milliliter (mcg/mL).

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=45 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=49 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Beta 2 Microglobulin Levels During the Double-Blind Treatment Period Baseline (n=39,49)	2.0 mg/L Standard Deviation 0.6	2.0 mg/L Standard Deviation 0.6
Beta 2 Microglobulin Levels During the Double-Blind Treatment Period Week 1 (n=45,48)	2.0 mg/L Standard Deviation 0.5	2.1 mg/L Standard Deviation 0.7
Beta 2 Microglobulin Levels During the Double-Blind Treatment Period Week 4 (n=45,47)	2.0 mg/L Standard Deviation 0.5	2.0 mg/L Standard Deviation 0.5

SECONDARY outcome

Timeframe: Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Beta 2 Microglobulin is a biological marker of inflammation. If baseline value was equal to 0, it was replaced by 0.1 to calculate the change from baseline.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=38 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=44 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period Week 1 (n=38,44)	2.2 percent change Standard Deviation 18.1	4.2 percent change Standard Deviation 19.6
Percent Change From Baseline in Beta 2 Microglobulin Levels During the Double-Blind Treatment Period Week 4 (n=37,44)	-2.3 percent change Standard Deviation 14.1	-0.8 percent change Standard Deviation 19.4

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

To describe bone mineral density (BMD), standardized values were calculated for lumbar spine, hip, femoral neck, and trochanter, taking into account the type of Dual energy X ray absorptiometry (DXA) used. All DXA at baseline were taken into account (done from before screening to Week 8). DXA at end of study were taken into account if they were done after at least 6 infusions of tocilizumab. Values were measured in milligrams per square centimeter (mg/cm\^2).

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=90 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Bone Mineral Density Lumbar spine, Baseline (n=89)	1018.0 mg/cm^2 Standard Deviation 155.4	—
Bone Mineral Density Lumbar spine, Week 48 (n=82)	1033.4 mg/cm^2 Standard Deviation 157.9	—
Bone Mineral Density Hip, Baseline (n=90)	887.3 mg/cm^2 Standard Deviation 129.8	—
Bone Mineral Density Hip, Week 48 (n=83)	891.3 mg/cm^2 Standard Deviation 131.6	—
Bone Mineral Density Femoral neck, Baseline (n=90)	825.0 mg/cm^2 Standard Deviation 122.7	—
Bone Mineral Density Femoral neck, Week 48 (n=83)	821.8 mg/cm^2 Standard Deviation 121.6	—
Bone Mineral Density Trochanter, Baseline (n=90)	696.2 mg/cm^2 Standard Deviation 124.3	—
Bone Mineral Density Trochanter, Week 48 (n=83)	700.3 mg/cm^2 Standard Deviation 122.7	—

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 48 (n=82)	60 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Baseline (n=103)	74 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 8 (n=99)	74 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 12 (n=97)	71 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 16 (n=95)	71 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 20 (n=93)	70 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 24 (n=93)	71 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 28 (n=91)	68 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 32 (n=90)	68 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 36 (n=85)	69 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 40 (n=82)	65 percentage of participants	—
Percentage of Participants Treated With Corticosteroids Over the 1-Year Tocilizumab Period Week 44 (n=82)	60 percentage of participants	—

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

S-Sclerostin and P-Dkk1 are biological markers of bone and cartilage metabolism measured as picograms/milliliter (pg/mL). Baseline is the closest value plus or minus (+/-) 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period S-Sclerostin, Baseline (n=103)	0.51 pg/mL Standard Deviation 0.22	—
S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period S-Sclerostin, Week 12 (n=93)	0.55 pg/mL Standard Deviation 0.20	—
S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period S-Sclerostin, Week 24 (n=84)	0.51 pg/mL Standard Deviation 0.19	—
S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period S-Sclerostin, Week 48 (n=75)	0.54 pg/mL Standard Deviation 0.21	—
S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period P-Dkk1, Baseline (n=102)	847.50 pg/mL Standard Deviation 610.22	—
S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period P-Dkk1, Week 12 (n=86)	572.45 pg/mL Standard Deviation 350.85	—
S-Sclerostin and P-Dkk1 (Wnt Signaling Inhibitor Dickkopf) Over the 1-Year Tocilizumab Period P-Dkk1, Week 48 (n=72)	685.79 pg/mL Standard Deviation 482.73	—

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

S-PIIINP, S-CTX-I, and S-PINP are biological markers of bone and cartilage metabolism. Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-CTX-I, Week 48 (n=77)	0.33 ng/mL Standard Deviation 0.18	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-PINP, Baseline (n=103)	41.15 ng/mL Standard Deviation 23.95	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-PINP, Week 12 (n=93)	52.33 ng/mL Standard Deviation 32.66	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-PINP, Week 48 (n=77)	53.16 ng/mL Standard Deviation 30.14	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-PIIINP, Baseline (n=103)	5.59 ng/mL Standard Deviation 2.06	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-PIIINP, Week 12 (n=94)	6.07 ng/mL Standard Deviation 2.39	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-PIIINP, Week 24 (n=85)	5.74 ng/mL Standard Deviation 2.27	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-PIIINP, Week 48 (n=77)	5.86 ng/mL Standard Deviation 2.12	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-CTX-I, Baseline (n=103)	0.35 ng/mL Standard Deviation 0.22	—
Serum Procollagen Type II N-Propeptide (s-PIINP), Serum Procollagen Type I N Propeptide (s-PINP), and Serum Carboxy-Terminal Collagen Crosslinks-1 (s-CTX-I) Over the 1-Year Tocilizumab Period s-CTX-I, Week 12 (n=93)	0.35 ng/mL Standard Deviation 0.20	—

SECONDARY outcome

Timeframe: Baseline and Weeks 12 and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

S-OGP is a biological marker of bone and cartilage metabolism measured as picomoles per liter (pmol/L). Baseline is the closest value +/- 1 month around the first tocilizumab infusion. If values before and after the first infusion were eligible, the value before was taken into account.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period Baseline (n=103)	3.97 pmol/L Standard Deviation 1.27	—
Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period Week 12 (n=93)	3.94 pmol/L Standard Deviation 1.20	—
Serum Osteogenic Growth Peptide (s-OGP) Over the 1-Year Tocilizumab Period Week 48 (n=77)	3.90 pmol/L Standard Deviation 1.21	—

SECONDARY outcome

Timeframe: Baseline and Weeks 24 and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Before entering the study, participants had to be treated with MTX for at least 12 weeks and at a stable dose for at least 8 weeks before the screening visit (10-25 mg per week \[mg/week\] of oral or parenteral MTX). During the study, treatment with MTX had to be stable during the first month and then could be continued or modified, at the investigator's discretion.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Weekly Methotrexate (MTX) Dose Baseline (n=103)	17.7 mg/week Standard Deviation 4.2	—
Weekly Methotrexate (MTX) Dose Week 24 (n=91)	17.1 mg/week Standard Deviation 4.4	—
Weekly Methotrexate (MTX) Dose Week 48 (n=77)	16.9 mg/week Standard Deviation 4.6	—

SECONDARY outcome

Timeframe: Screening and Week 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
HAQ-DI During the Double-Blind Treatment Period Screening (n=50,53)	1.62 units on a scale Standard Deviation 0.56	1.60 units on a scale Standard Deviation 0.58
HAQ-DI During the Double-Blind Treatment Period Week 4 (n=50,51)	1.44 units on a scale Standard Deviation 0.60	1.39 units on a scale Standard Deviation 0.65
HAQ-DI During the Double-Blind Treatment Period Change at Week 4 (n=50,51)	-0.18 units on a scale Standard Deviation 0.47	-0.22 units on a scale Standard Deviation 0.49

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 48

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=47 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=56 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
HAQ-DI During the Open Treatment Period Baseline (n=47,56)	1.45 units on a scale Standard Deviation 0.61	1.62 units on a scale Standard Deviation 0.57
HAQ-DI During the Open Treatment Period Week 12 (n=45,49)	1.19 units on a scale Standard Deviation 0.68	1.06 units on a scale Standard Deviation 0.70
HAQ-DI During the Open Treatment Period Change at Week 12 (n=45,49)	-0.29 units on a scale Standard Deviation 0.52	-0.62 units on a scale Standard Deviation 0.62
HAQ-DI During the Open Treatment Period Week 24 (n=39,50)	1.00 units on a scale Standard Deviation 0.69	1.01 units on a scale Standard Deviation 0.71
HAQ-DI During the Open Treatment Period Change at Week 24 (n=39,50)	-0.50 units on a scale Standard Deviation 0.54	-0.68 units on a scale Standard Deviation 0.61
HAQ-DI During the Open Treatment Period Week 36 (n=39,45)	1.05 units on a scale Standard Deviation 0.76	1.02 units on a scale Standard Deviation 0.71
HAQ-DI During the Open Treatment Period Change at Week 36 (n=39,45)	-0.44 units on a scale Standard Deviation 0.75	-0.64 units on a scale Standard Deviation 0.64
HAQ-DI During the Open Treatment Period Week 48 (n=37,45)	0.98 units on a scale Standard Deviation 0.78	0.95 units on a scale Standard Deviation 0.63
HAQ-DI During the Open Treatment Period Change at Week 48 (n=37,45)	-0.47 units on a scale Standard Deviation 0.71	-0.72 units on a scale Standard Deviation 0.60

SECONDARY outcome

Timeframe: Day 0, Week 1, and Week 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.

FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the patient's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Baseline = Last available value before Day 0 (screening or Day 0) for participants with first tocilizumab infusion at Day 0 and last value available before Week 4 (Week 1 or Week 4) for participants with first tocilizumab infusion at Week 4.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period Day 0 (n=50,52)	23.9 units on a scale Standard Deviation 10.1	26.0 units on a scale Standard Deviation 10.6
Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period Week 1 (n=48,52)	27.3 units on a scale Standard Deviation 11.7	27.7 units on a scale Standard Deviation 10.4
Functional Assessment of Chronic Illness in Therapy - Fatigue (FACIT-F) During the Double-Blind Treatment Period Week 4 (n=49,52)	29.2 units on a scale Standard Deviation 11.0	28.9 units on a scale Standard Deviation 11.0

SECONDARY outcome

Timeframe: Week 1 and Week 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=49 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=52 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period Week 1 (n=48,51)	24.6 percent change Standard Deviation 29.0	22.7 percent change Standard Deviation 61.5
Percent Change From Baseline in FACIT-F During the Double-Blind Treatment Period Week 4 (n=49,52)	37.7 percent change Standard Deviation 77.1	41.7 percent change Standard Deviation 167.9

SECONDARY outcome

Timeframe: Baseline, Weeks 12, 24, 36, and 48

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=102 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
FACIT-F During the Open Treatment Period Baseline (n=102)	27.1 units on a scale Standard Deviation 11.1	—
FACIT-F During the Open Treatment Period Week 12 (n=93)	33.7 units on a scale Standard Deviation 11.2	—
FACIT-F During the Open Treatment Period Week 24 (n=90)	35.4 units on a scale Standard Deviation 10.4	—
FACIT-F During the Open Treatment Period Week 36 (n=82)	34.0 units on a scale Standard Deviation 10.3	—
FACIT-F During the Open Treatment Period Week 48 (n=82)	34.9 units on a scale Standard Deviation 10.6	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit.

Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as grams per deciliter (g/dL).

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Hemoglobin Concentration During the Double-Blind Treatment Period Baseline (n=50,53)	12.97 g/dL Standard Deviation 1.37	12.74 g/dL Standard Deviation 1.49
Hemoglobin Concentration During the Double-Blind Treatment Period Week 1 (n=50,51)	12.96 g/dL Standard Deviation 1.33	13.04 g/dL Standard Deviation 1.38
Hemoglobin Concentration During the Double-Blind Treatment Period Change at Week 1 (n=50,51)	-0.01 g/dL Standard Deviation 0.54	0.34 g/dL Standard Deviation 0.54
Hemoglobin Concentration During the Double-Blind Treatment Period Week 4 (n=50,53)	12.88 g/dL Standard Deviation 1.46	13.10 g/dL Standard Deviation 1.41
Hemoglobin Concentration During the Double-Blind Treatment Period Change at Week 4 (n=50,53)	-0.09 g/dL Standard Deviation 0.54	0.36 g/dL Standard Deviation 0.69

SECONDARY outcome

Timeframe: Baseline, Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Hemoglobin concentrations were determined at each visit to evaluate anemia in participants and measured as g/dL.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Hemoglobin Concentration During the Open Treatment Period Baseline (n=103)	12.80 g/dL Standard Deviation 1.47	—
Hemoglobin Concentration During the Open Treatment Period Week 8 (n=99)	13.14 g/dL Standard Deviation 1.41	—
Hemoglobin Concentration During the Open Treatment Period Week 12 (n=97)	13.37 g/dL Standard Deviation 1.40	—
Hemoglobin Concentration During the Open Treatment Period Week 16 (n=95)	13.24 g/dL Standard Deviation 1.51	—
Hemoglobin Concentration During the Open Treatment Period Week 20 (n=91)	13.27 g/dL Standard Deviation 1.46	—
Hemoglobin Concentration During the Open Treatment Period Week 24 (n=92)	13.38 g/dL Standard Deviation 1.43	—
Hemoglobin Concentration During the Open Treatment Period Week 28 (n=91)	13.47 g/dL Standard Deviation 1.32	—
Hemoglobin Concentration During the Open Treatment Period Week 32 (n=90)	13.46 g/dL Standard Deviation 1.35	—
Hemoglobin Concentration During the Open Treatment Period Week 36 (n=84)	13.50 g/dL Standard Deviation 1.31	—
Hemoglobin Concentration During the Open Treatment Period Week 40 (n=81)	13.49 g/dL Standard Deviation 1.35	—
Hemoglobin Concentration During the Open Treatment Period Week 44 (n=82)	13.48 g/dL Standard Deviation 1.37	—
Hemoglobin Concentration During the Open Treatment Period Week 48 (n=81)	13.64 g/dL Standard Deviation 1.32	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period Baseline (n=50,53)	12.0 tender joints Standard Deviation 6.6	13.4 tender joints Standard Deviation 6.7
Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period Week 1 (n=49,53)	11.0 tender joints Standard Deviation 7.1	10.6 tender joints Standard Deviation 6.7
Tender Joint Count (TJC) Based on 28-Joint Count During the Double-Blind Treatment Period Week 4 (n=50,53)	10.6 tender joints Standard Deviation 6.7	9.9 tender joints Standard Deviation 7.7

SECONDARY outcome

Timeframe: Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period Week 1 (n=49,53)	3.4 percent change Standard Deviation 74.4	16.7 percent change Standard Deviation 266.7
Percent Change From Baseline in TJC Based on 28-Joint Count During the Double-Blind Treatment Period Week 4 (n=50,53)	25.7 percent change Standard Deviation 180.4	9.3 percent change Standard Deviation 268.6

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Twenty-eight joints were assessed for tenderness and joints were classified as tender (1)/not tender (0), giving a total possible tender joint count score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
TJC Based on 28-Joint Count During the Open Treatment Period Baseline (n=103)	12.3 tender joints Standard Deviation 6.9	—
TJC Based on 28-Joint Count During the Open Treatment Period Week 12 (n=97)	5.5 tender joints Standard Deviation 5.6	—
TJC Based on 28-Joint Count During the Open Treatment Period Week 24 (n=92)	4.0 tender joints Standard Deviation 4.7	—
TJC Based on 28-Joint Count During the Open Treatment Period Week 36 (n=84)	3.6 tender joints Standard Deviation 4.5	—
TJC Based on 28-Joint Count During the Open Treatment Period Week 48 (n=82)	3.3 tender joints Standard Deviation 4.7	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 4

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Forty joints were assessed for tenderness (5 MCP \[left and right\] joints, 5 PIP \[left and right joints\], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP \[left and right\] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
TJC Based on 40-Joint Count During the Double-Blind Treatment Period Baseline (n=50,53)	17.7 tender joints Standard Deviation 9.1	18.3 tender joints Standard Deviation 8.0
TJC Based on 40-Joint Count During the Double-Blind Treatment Period Week 1 (n=49,53)	16.3 tender joints Standard Deviation 9.9	14.6 tender joints Standard Deviation 9.4
TJC Based on 40-Joint Count During the Double-Blind Treatment Period Week 4 (n=50,53)	15.0 tender joints Standard Deviation 8.6	14.0 tender joints Standard Deviation 10.7

SECONDARY outcome

Timeframe: Weeks 1 and 4

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period Week 1 (n=49,53)	-2.6 percent change Standard Deviation 59.5	-22.1 percent change Standard Deviation 39.6
Percent Change From Baseline in TJC Based on 40-Joint Count During the Double-Blind Treatment Period Week 4 (n=50,53)	-1.5 percent change Standard Deviation 63.5	-23.1 percent change Standard Deviation 49.3

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Forty joints were assessed for tenderness (5 MCP \[left and right\] joints, 5 PIP \[left and right joints\], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP \[left and right\] joints). Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
TJC Based on 40-Joint Count During the Open Treatment Period Baseline (n=103)	17.0 tender joints Standard Deviation 8.7	—
TJC Based on 40-Joint Count During the Open Treatment Period Week 12 (n=97)	7.9 tender joints Standard Deviation 7.7	—
TJC Based on 40-Joint Count During the Open Treatment Period Week 24 (n=92)	5.9 tender joints Standard Deviation 6.5	—
TJC Based on 40-Joint Count During the Open Treatment Period Week 36 (n=84)	5.2 tender joints Standard Deviation 6.2	—
TJC Based on 40-Joint Count During the Open Treatment Period Week 48 (n=82)	5.0 tender joints Standard Deviation 6.5	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = value at Day 0 if available, value at screening otherwise.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period Baseline (n=50,53)	8.3 swollen joints Standard Deviation 4.2	8.5 swollen joints Standard Deviation 4.5
Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period Week 1 (n=49,53)	6.9 swollen joints Standard Deviation 4.4	7.0 swollen joints Standard Deviation 4.8
Swollen Joint Count (SJC) Based on 28-Joint Count During the Double-Blind Treatment Period Week 4 (n=50,53)	7.7 swollen joints Standard Deviation 4.6	5.8 swollen joints Standard Deviation 3.8

SECONDARY outcome

Timeframe: Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period Week 1 (n=49,53)	-12.0 percent change Standard Deviation 54.0	-10.9 percent change Standard Deviation 70.6
Percent Change From Baseline in SJC Based on 28-Joint Count During the Double-Blind Treatment Period Week 4 (n=50,53)	-1.1 percent change Standard Deviation 53.7	-27.3 percent change Standard Deviation 47.6

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Twenty-eight joints were assessed for swelling (5 MCP \[left and right\] joints, 5 PIP \[left and right joints\], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP \[left and right\] joints) . Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 28. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period Baseline (n=103)	8.2 swollen joints Standard Deviation 4.6	—
Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period Week 12 (n=97)	3.8 swollen joints Standard Deviation 4.0	—
Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period Week 24 (n=92)	3.1 swollen joints Standard Deviation 3.4	—
Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period Week 36 (n=84)	2.2 swollen joints Standard Deviation 3.0	—
Swollen Joint Count (SJC) Based on 28-Joint Count During the Open Treatment Period Week 48 (n=82)	1.7 swollen joints Standard Deviation 2.6	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Forty joints were assessed for swelling (5 MCP \[left and right\] joints, 5 PIP \[left and right joints\], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP \[left and right\] joints). Joints were classified as swollen (1)/not swollen (0) giving a total possible SJC score of 0 to 40. Baseline = value at Day 0 if available, value at screening otherwise.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
SJC Based on 40-Joint Count During the Double-Blind Treatment Period Baseline (n=50,53)	10.1 swollen joints Standard Deviation 5.0	10.4 swollen joints Standard Deviation 5.1
SJC Based on 40-Joint Count During the Double-Blind Treatment Period Week 1 (n=49,53)	8.7 swollen joints Standard Deviation 5.3	8.0 swollen joints Standard Deviation 5.3
SJC Based on 40-Joint Count During the Double-Blind Treatment Period Week 4 (n=50,53)	9.8 swollen joints Standard Deviation 6.0	6.7 swollen joints Standard Deviation 4.5

SECONDARY outcome

Timeframe: Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period Week 1 (n=49,53)	-9.2 percent change Standard Deviation 58.1	-19.2 percent change Standard Deviation 45.3
Percent Change From Baseline in SJC Based on 40-Joint Count During the Double-Blind Treatment Period Week 4 (n=50,53)	7.7 percent change Standard Deviation 73.8	-30.0 percent change Standard Deviation 45.9

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

Forty joints were assessed for swelling (5 MCP \[left and right\] joints, 5 PIP \[left and right joints\], left and right wrists, elbows, shoulders, knees, and ankles, and 5 MTP \[left and right\] joints). Joints were classified as swollen (1)/not swollen (0) for a total possible score of 0 to 40. Baseline = Last value available before Day 0 (selection or Day 0) for placebo and last value available before Week 4 (Week 1 or Week 4) for tocilizumab group.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
SJC Based on 40-Joint Count During the Open Treatment Period Baseline (n=103)	10.2 swollen joints Standard Deviation 5.7	—
SJC Based on 40-Joint Count During the Open Treatment Period Week 12 (n=97)	4.4 swollen joints Standard Deviation 4.7	—
SJC Based on 40-Joint Count During the Open Treatment Period Week 24 (n=92)	3.5 swollen joints Standard Deviation 3.7	—
SJC Based on 40-Joint Count During the Open Treatment Period Week 36 (n=84)	2.5 swollen joints Standard Deviation 3.3	—
SJC Based on 40-Joint Count During the Open Treatment Period Week 48 (n=82)	2.1 swollen joints Standard Deviation 3.0	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 less than or equal to (≤3.2) = low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period Baseline (n=50,53)	5.66 units on a scale Standard Deviation 1.02	5.64 units on a scale Standard Deviation 1.04
Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period Week 1 (n=41,40)	5.40 units on a scale Standard Deviation 1.04	4.41 units on a scale Standard Deviation 1.05
Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period Change at Week 1 (n=41,40)	-0.43 units on a scale Standard Deviation 0.81	-1.12 units on a scale Standard Deviation 0.61
Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period Week 4 (n=45,50)	5.27 units on a scale Standard Deviation 1.00	4.00 units on a scale Standard Deviation 1.26
Disease Activity Score Based on 28-Joints Count (DAS28) During the Double-Blind Treatment Period Change at Week 4 (n=45,50)	-0.43 units on a scale Standard Deviation 0.90	-1.68 units on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population n=number of participants assessed for the specified parameter at a given visit.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=103 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
DAS28 During the Open Treatment Period Baseline (n=102)	5.51 units on a scale Standard Deviation 1.04	—
DAS28 During the Open Treatment Period Week 12 (n=95)	2.98 units on a scale Standard Deviation 1.40	—
DAS28 During the Open Treatment Period Week 24 (n=89)	2.64 units on a scale Standard Deviation 1.31	—
DAS28 During the Open Treatment Period Week 36 (n=83)	2.51 units on a scale Standard Deviation 1.36	—
DAS28 During the Open Treatment Period Week 48 (n=79)	2.22 units on a scale Standard Deviation 1.28	—

SECONDARY outcome

Timeframe: Baseline and Weeks 1 and 4

Population: ITT Population; n=number of participants assessed for the specified parameter at a given visit. Changes from baseline were described for participants without missing data.

DAS40 calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=50 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab n=53 Participants Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period Baseline (n=50,53)	6.15 units on a scale Standard Deviation 1.03	6.08 units on a scale Standard Deviation 1.04
Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period Week 1 (n=41,40)	5.88 units on a scale Standard Deviation 1.12	4.71 units on a scale Standard Deviation 1.16
Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period Change at Week 1 (n=41,40)	-0.43 units on a scale Standard Deviation 0.85	-1.25 units on a scale Standard Deviation 0.64
Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period Week 4 (n=45,50)	5.70 units on a scale Standard Deviation 1.03	4.39 units on a scale Standard Deviation 1.37
Disease Activity Score Based on 40-Joints Count (DAS40) During the Double-Blind Treatment Period Change at Week 4 (n=45,50)	-0.49 units on a scale Standard Deviation 1.03	-1.75 units on a scale Standard Deviation 1.03

SECONDARY outcome

Timeframe: Baseline and Weeks 12, 24, 36, and 48

Population: One-Year Efficacy Population; n=number of participants assessed for the specified parameter at a given visit.

DAS40 was calculated from the number of swollen joints and tender joints using the 40-joint count, the erythrocyte sedimentation rate, and global health assessment (participant-rated global assessment of disease activity using 10-mm VAS); DAS40 score ranged from 0 to 10, where higher scores correspond to greater disease activity.

Outcome measures

Outcome measures
Measure	Placebo, Tocilizumab n=102 Participants Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.	Tocilizumab Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
DAS40 During the Open Treatment Period Baseline (n=102)	5.96 units on a scale Standard Deviation 1.06	—
DAS40 During the Open Treatment Period Week 12 (n=95)	3.27 units on a scale Standard Deviation 1.49	—
DAS40 During the Open Treatment Period Week 24 (n=89)	2.89 units on a scale Standard Deviation 1.40	—
DAS40 During the Open Treatment Period Week 36 (n=83)	2.76 units on a scale Standard Deviation 1.42	—
DAS40 During the Open Treatment Period Week 48 (n=79)	2.48 units on a scale Standard Deviation 1.40	—

Adverse Events

Tocilizumab

Serious events: 13 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo, Tocilizumab

Serious events: 11 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann- LaRoche

Phone: 800-821-8590

Email: [email protected]

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 after the first publication or presentation that involves the overall study. 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

Measure	Tocilizumab n=53 participants at risk Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.	Placebo, Tocilizumab n=50 participants at risk Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
Musculoskeletal and connective tissue disorders Arthralgia	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Musculoskeletal and connective tissue disorders Chondrolysis	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Infections and infestations Bronchitis	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Infections and infestations Pneumonia	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Infections and infestations Sepsis	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Musculoskeletal and connective tissue disorders Plantar fasciitis	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Musculoskeletal and connective tissue disorders Rheumatoid nodule	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Infections and infestations Pyelonephritis	3.8% 2/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
General disorders Malaise	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
General disorders Pyrexia	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Injury, poisoning and procedural complications Chest injury	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Investigations ALT increased	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Investigations Transaminases increased	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Nervous system disorders Coma	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Nervous system disorders Sciatica	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Blood and lymphatic system disorders Anaemia	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Cardiac disorders Myocardial infarction	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ameloblastoma	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Vascular disorders Deep vein thrombosis	1.9% 1/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	0.00% 0/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/53 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.	2.0% 1/50 • Adverse events were recorded throughout the study, from date of Screening until the end of study at Week 48.