Trial Outcomes & Findings for A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA). (NCT NCT01734993)

Last Updated: 2016-11-28

Results Overview

An adverse event (AE) was defined as any untoward medical occurrence in a participant who was administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A SAE was any untoward medical occurrence that at any dose resulted in death, was life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, and congenital anomaly/birth defect. AEs included SAEs as well as non-serious AEs.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

11 participants

Primary outcome timeframe

Baseline up to approximately 142 weeks

Results posted on

2016-11-28

Participant Flow

A total of 12 participants were screened at 6 sites in France, of which 11 participants were enrolled.

Participant milestones

Participant milestones
Measure	Tocilizumab Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 long term extension (LTE) study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of greater than \[\>\] 1.2 points) were administered tocilizumab (TCZ) in this long-term extension study, at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Tocilizumab Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 long term extension (LTE) study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of greater than \[\>\] 1.2 points) were administered tocilizumab (TCZ) in this long-term extension study, at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Age, Continuous	63.91 years STANDARD_DEVIATION 11.96 • n=113 Participants
Sex: Female, Male Female	7 Participants n=113 Participants
Sex: Female, Male Male	4 Participants n=113 Participants

PRIMARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AE	100 Percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAE	18.2 Percentage of participants

PRIMARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included SAEs as well as non-serious AEs. Causality of AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation \[DC\], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AEs with causality of certain, probable/likely, and possible were considered TCZ related.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With AEs and SAEs Related to TCZ Related AE	72.7 Percentage of participants
Percentage of Participants With AEs and SAEs Related to TCZ Related SAE	9.1 Percentage of participants

PRIMARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population

Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With Adverse Events of Special Interest (AESIs)	18.2 Percentage of participants

PRIMARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population

AESI for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Percentage of participants with AESI related to the drug were presented. Causality of AESIs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on DC, relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). AESIs with causality of certain, probable/likely, and possible were considered TCZ related.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With AESIs Related to TCZ	18.2 Percentage of participants

PRIMARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety Population

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Percentage of participants with AE causing drug discontinuation, interruption and increase or decrease in dose of drug was presented.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification AE Leading to Discontinuation	9.1 Percentage of participants
Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification AE Leading to Interruption	63.6 Percentage of participants
Percentage of Participants With AEs Leading to TCZ Discontinuation, Interruption, or Dose Modification AE Leading to Dose Modification	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population

Criteria for potentially clinically important (PCI) change in vital signs: heart rate value of less than (\<) 40 beats per minute and value greater than (\>) 150 beats per minute, systolic blood pressure (SBP) of \< 80 or \>210 millimeter of mercury (mmHg), diastolic blood pressure (DBP) of \<40 or \>130 mmHg, body temperature \<32 or \> 40 degrees Celsius, respiratory rate of \<10 or \> 50 breaths/minute and criteria for PCI change in physical examination: \>/=10% increase or decrease of body weight in kilograms (kg).

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With Clinically Significant Physical Examinations and Vital Signs Abnormalities	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population

Criteria for laboratory tests clinically significant abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(\< 0.8\*lower limit of normal\[LLN\]); leucocytes (\<0.6/greater than \[\>\]1.5\*upper limit of normal \[ULN\]); platelets (\<0.5\*LLN\>\</0\>1.75\*ULN); neutrophils, lymphocytes (\<0.8\*LLN\>\</0\>1.2\*ULN); eosinophils, basophils, monocytes (\>1.2\*ULN); total bilirubin, direct bilirubin, indirect bilirubin (\>1.5\*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (\>3\*ULN), total protein, albumin (\<0.8\*LLN\>\</0\>1.2\*ULN); creatinine, urea (\>1.3\*ULN); glucose (\<0.6\*LLN\>\</0\>1.5\*ULN); uric acid (\>1.2\*ULN); sodium, potassium, chloride, calcium, bicarbonate (\<0.9\*LLN\>\</0\>1.1\*ULN); urine RBCs, urine white blood cells (WBCs) (\> or equal\[=\]20 high-powered field), urine bacteria \>20 high-powered field. Overall percentage of participants with any clinically significant laboratory abnormality was reported.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With Clinically Significant Laboratory Abnormalities	9.1 Percentage of participants

PRIMARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With Anti-TCZ Antibodies	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.

The DAS 28 ESR score is a measure of the participant's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment (PtGA) of disease activity (visual analog scale \[VAS\]: 0 millimeter \[mm\] = no disease activity to 100 mm=maximum disease activity) and the erythrocyte sedimentation rate (ESR in millimeters per hour \[mm/hr\]). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt (SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*PtGA of disease activity. A total possible score of 0 to approximately 10, with higher score indicating more severe disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Baseline (n=11)	1.81 Units on a scale Standard Deviation 0.87
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 12 (n=8)	0.16 Units on a scale Standard Deviation 1.59
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 24 (n=9)	-0.14 Units on a scale Standard Deviation 1.17
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 36 (n=9)	-0.02 Units on a scale Standard Deviation 1.30
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 48 (n=10)	-0.32 Units on a scale Standard Deviation 0.93
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 60 (n=10)	-0.33 Units on a scale Standard Deviation 1.14
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 72 (n=10)	-0.35 Units on a scale Standard Deviation 0.92
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 84 (n=9)	0.28 Units on a scale Standard Deviation 1.23
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 96 (n=9)	-0.36 Units on a scale Standard Deviation 1.11
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 108 (n=7)	-0.14 Units on a scale Standard Deviation 1.55
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Week 120 (n=2)	-0.75 Units on a scale Standard Deviation 0.88
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Completer last visit (n=9)	-0.16 Units on a scale Standard Deviation 1.19
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Early withdrawal (n=2)	2.76 Units on a scale Standard Deviation 0.87
Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score Change at Last visit (n=11)	0.38 Units on a scale Standard Deviation 1.61

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety population. Here, N (number of participants analyzed) represents the number of participants evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.

The SDAI was calculated as (SJC \[28 joints\] + TJC \[28 joints\] + VAS ptGA + VAS physician global assessment of disease activity + C-reactive Protein (CRP) level in milligram/deciliter \[mg/dL\]). VAS assessments: 0 centimeters (cm)=no disease activity to 10 cm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=5 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 60 (n=2)	-1.02 Units on a scale Standard Deviation 1.32
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Completer last visit (n=2)	0.69 Units on a scale Standard Deviation 5.02
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Baseline (n=5)	7.21 Units on a scale Standard Deviation 4.15
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 12 (n=5)	9.17 Units on a scale Standard Deviation 12.63
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 24 (n=2)	8.48 Units on a scale Standard Deviation 7.81
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 36 (n=3)	4.50 Units on a scale Standard Deviation 4.61
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 48 (n=2)	-1.02 Units on a scale Standard Deviation 0.23
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 72 (n=3)	4.19 Units on a scale Standard Deviation 1.66
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 84 (n=3)	0.83 Units on a scale Standard Deviation 3.43
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 96 (n=3)	0.60 Units on a scale Standard Deviation 4.95
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 108 (n=3)	5.25 Units on a scale Standard Deviation 8.15
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Week 120 (n=0)	NA Units on a scale Standard Deviation NA No participant was evaluable for the specified time point.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Early withdrawal (n=1)	17.38 Units on a scale Standard Deviation NA Standard deviation data is not applicable since only 1 participant was evaluable at indicated time point.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score Change at Last visit (n=3)	6.25 Units on a scale Standard Deviation 10.27

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.

For TJC a total of 28 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 28 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in TJC Baseline (n=11)	1.27 Tender Joints Standard Deviation 1.35
Change From Baseline in TJC Change at Week 48 (n=10)	0.50 Tender Joints Standard Deviation 1.84
Change From Baseline in TJC Change at Week 96 (n=9)	0.11 Tender Joints Standard Deviation 1.27
Change From Baseline in TJC Change at Week 12 (n=10)	0.50 Tender Joints Standard Deviation 2.27
Change From Baseline in TJC Change at Week 24 (n=10)	1.20 Tender Joints Standard Deviation 3.01
Change From Baseline in TJC Change at Week 36 (n=10)	1.00 Tender Joints Standard Deviation 1.89
Change From Baseline in TJC Change at Week 60 (n=10)	1.20 Tender Joints Standard Deviation 5.31
Change From Baseline in TJC Change at Week 72 (n=10)	0.60 Tender Joints Standard Deviation 3.06
Change From Baseline in TJC Change at Week 84 (n=9)	0.44 Tender Joints Standard Deviation 1.51
Change From Baseline in TJC Change at Week 108 (n=7)	1.57 Tender Joints Standard Deviation 5.68
Change From Baseline in TJC Change at Week 120 (n=2)	0.00 Tender Joints Standard Deviation 1.41
Change From Baseline in TJC Change at Completer Last Visit (n=9)	-0.44 Tender Joints Standard Deviation 1.24
Change From Baseline in TJC Change at Early Withdrawal n=2)	6.50 Tender Joints Standard Deviation 0.71
Change From Baseline in TJC Change at Last Visit (n=11)	0.82 Tender Joints Standard Deviation 3.03

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.

For SJC, a total of 28 joints were assessed. The presence of a swollen joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 28 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in SJC Change at Week 36 (n=10)	-0.60 Swollen Joints Standard Deviation 2.22
Change From Baseline in SJC Change at Week 48 (n=10)	-0.80 Swollen Joints Standard Deviation 1.75
Change From Baseline in SJC Change at Week 60 (n=10)	-0.70 Swollen Joints Standard Deviation 1.49
Change From Baseline in SJC Baseline (n=11)	1.00 Swollen Joints Standard Deviation 1.67
Change From Baseline in SJC Change at Week 12 (n=10)	0.50 Swollen Joints Standard Deviation 2.37
Change From Baseline in SJC Change at Week 24 (n=10)	-0.50 Swollen Joints Standard Deviation 1.84
Change From Baseline in SJC Change at Week 72 (n=10)	-0.30 Swollen Joints Standard Deviation 2.31
Change From Baseline in SJC Change at Week 84 (n=9)	-0.78 Swollen Joints Standard Deviation 1.09
Change From Baseline in SJC Change at Week 96 (n=9)	-0.67 Swollen Joints Standard Deviation 1.41
Change From Baseline in SJC Change at Week 108 (n=7)	0.14 Swollen Joints Standard Deviation 2.48
Change From Baseline in SJC Change at Week 120 (n=2)	-0.50 Swollen Joints Standard Deviation 0.71
Change From Baseline in SJC Change at Completer Last Visit (n=9)	-0.56 Swollen Joints Standard Deviation 2.24
Change From Baseline in SJC Change at Early Withdrawal (n=2)	3.5 Swollen Joints Standard Deviation 2.12
Change From Baseline in SJC Change at Last Visit (n=11)	0.18 Swollen Joints Standard Deviation 2.68

SECONDARY outcome

Timeframe: Week 48, 108

Clinical remission defined as:DAS28-ESR score \< 2.6 and/or SDAI score \</= 3.3.DAS28 score is measure of subject's disease activity calculated using TJC \[28 joints\],SJC \[28 joints\],PtGA of disease activity \[ VAS:0mm= no disease activity to 100 mm=maximum disease activity\] and ESR (mm/hr). DAS28 was calculated as DAS28-ESR = 0.56\*sqrt (TJC28) + 0.28\*sqrt(SJC28) + 0.70\* ln ESR + 0.014\*PtGA of disease activity. DAS28-ESR score ranged from 0 to approximately 10, higher score indicating more severe disease activity. SDAI was calculated =\[SJC (28 joints) + TJC (28 joints) + VAS PtGA + VAS physician global assessment of disease activity+CRP level(mg/dL)\]. VAS assessments:0 mm=no disease activity to 100 mm=maximum disease activity. SDAI score ranged from 0 to 86, with higher scores indicating increased disease activity.

Outcome measures

Outcome measures
Measure	Tocilizumab n=10 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With Clinical Remission Week 48 (n=10)	90 Percentage of participants
Percentage of Participants With Clinical Remission Week 108 (n=8)	75 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.

Outcome measures

Outcome measures
Measure	Tocilizumab n=6 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With Concomitant Corticosteroid Discontinuation	16.7 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population. Here, N (number of participants analyzed) represents the participants who received concomitant corticosteroids.

Outcome measures

Outcome measures
Measure	Tocilizumab n=6 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Percentage of Participants With Concomitant Corticosteroid Dose Reduction	50 Percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population. Here N (number of participants analyzed) represents the participants who discontinued concomitant corticosteroids

Time to corticosteroid discontinuation = (End date of corticosteroid treatment - date of first drug intake of this extension study) + 1.

Outcome measures

Outcome measures
Measure	Tocilizumab n=1 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Time to Concomitant Corticosteroid Discontinuation	472.00 Days

SECONDARY outcome

Timeframe: Baseline up to approximately 142 weeks

Population: Safety population. Here, N (number of participants analyzed) represents the participants who had concomitant corticosteroid dose reduction.

Time to corticosteroid dose reduction (days) = (Date of the first dose reduction of corticosteroid treatment - date of first drug intake of this extension study) + 1.

Outcome measures

Outcome measures
Measure	Tocilizumab n=3 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Time to Concomitant Corticosteroid Dose Reduction	75 Days Interval 15.0 to 758.0

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.

PtGA of disease activity over the previous 24 hours using a 100 mm VAS where left end of the line 0 mm =no disease activity and right end of the line 100 mm =maximum disease activity. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in PtGA of Disease Activity Baseline (n=11)	17.55 mm Standard Deviation 21.06
Change From Baseline in PtGA of Disease Activity Change at Week 12 (n=11)	11.82 mm Standard Deviation 36.19
Change From Baseline in PtGA of Disease Activity Change at Week 24 (n=10)	4.00 mm Standard Deviation 12.54
Change From Baseline in PtGA of Disease Activity Change at Week 36 (n=10)	0.90 mm Standard Deviation 26.82
Change From Baseline in PtGA of Disease Activity Change at Week 48 (n=9)	-4.89 mm Standard Deviation 14.16
Change From Baseline in PtGA of Disease Activity Change at Week 60 (n=9)	-0.89 mm Standard Deviation 20.75
Change From Baseline in PtGA of Disease Activity Change at Week 72 (n=9)	-4.44 mm Standard Deviation 17.54
Change From Baseline in PtGA of Disease Activity Change at Week 84 (n=9)	0.22 mm Standard Deviation 16.17
Change From Baseline in PtGA of Disease Activity Change at Week 96 (n=9)	-3.11 mm Standard Deviation 16.51
Change From Baseline in PtGA of Disease Activity Change at Week 108 (n=7)	-5.00 mm Standard Deviation 24.21
Change From Baseline in PtGA of Disease Activity Change at Week 120 (n=2)	-21.50 mm Standard Deviation 23.33
Change From Baseline in PtGA of Disease Activity Change at Completer last visit (n=8)	-6.38 mm Standard Deviation 14.48
Change From Baseline in PtGA of Disease Activity Change at Early withdrawal (n=2)	34.00 mm Standard Deviation 15.56
Change From Baseline in PtGA of Disease Activity Change at Last visit (n=10)	1.70 mm Standard Deviation 21.90

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety Population. Here, 'n' represents the number of participants available for assessment at a given time point.

Patient's assessment of pain over the previous 24 hours: using a VAS, left end of the line 0 mm=no pain to right end of the line 100 mm=unbearable pain. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in Patient's Assessment of Pain Baseline (n=11)	19.18 mm Standard Deviation 20.58
Change From Baseline in Patient's Assessment of Pain Change at Week 12 (n=11)	10.91 mm Standard Deviation 36.68
Change From Baseline in Patient's Assessment of Pain Change at Week 24 (n=10)	3.80 mm Standard Deviation 14.99
Change From Baseline in Patient's Assessment of Pain Change at Week 36 (n=10)	-1.90 mm Standard Deviation 20.00
Change From Baseline in Patient's Assessment of Pain Change at Week 48 (n=9)	-6.44 mm Standard Deviation 11.57
Change From Baseline in Patient's Assessment of Pain Change at Week 60 (n=9)	-3.78 mm Standard Deviation 15.63
Change From Baseline in Patient's Assessment of Pain Change at Week 72 (n=9)	-8.11 mm Standard Deviation 16.56
Change From Baseline in Patient's Assessment of Pain Change at Week 84 (n=9)	0.11 mm Standard Deviation 14.44
Change From Baseline in Patient's Assessment of Pain Change at Week 96 (n=9)	-8.22 mm Standard Deviation 13.22
Change From Baseline in Patient's Assessment of Pain Change at Week 108 (n=7)	-7.86 mm Standard Deviation 18.21
Change From Baseline in Patient's Assessment of Pain Change at Week 120 (n=2)	-20.00 mm Standard Deviation 26.87
Change From Baseline in Patient's Assessment of Pain Change at Completer last visit (n=8)	1.50 mm Standard Deviation 29.71
Change From Baseline in Patient's Assessment of Pain Change at Early withdrawal (n=2)	34.50 mm Standard Deviation 16.26
Change From Baseline in Patient's Assessment of Pain Change at Last visit (n=10)	8.10 mm Standard Deviation 30.16

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety population, Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.

The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=7 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Baseline (n=7)	0.77 Units on a scale Standard Deviation 0.55
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 12 (n=7)	-0.20 Units on a scale Standard Deviation 0.52
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 24 (n=7)	0.18 Units on a scale Standard Deviation 0.24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 36 (n=7)	-0.07 Units on a scale Standard Deviation 0.31
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 48 (n=7)	0.00 Units on a scale Standard Deviation 0.54
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 60 (n=7)	-0.13 Units on a scale Standard Deviation 0.35
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 72 (n=6)	-0.25 Units on a scale Standard Deviation 0.41
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 84 (n=5)	-0.18 Units on a scale Standard Deviation 0.62
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 96 (n=5)	0.08 Units on a scale Standard Deviation 0.07
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 108 (n=5)	-0.15 Units on a scale Standard Deviation 0.57
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Week 120 (n=1)	0.00 Units on a scale Standard Deviation NA Standard deviation data is not applicable since only 1 participant was evaluable at indicated time point.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Completer Last Visit (n=6)	0.10 Units on a scale Standard Deviation 0.43
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Early Withdrawal (n=1)	0.00 Units on a scale Standard Deviation NA Standard deviation data is not applicable since only 1 participant was evaluable at indicated time point.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Total Score Change at Last Visit (n=7)	0.09 Units on a scale Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety population. Here, N (number of participants analyzed) represents the participants who were evaluable for this outcome and 'n' represents the number of participants available for assessment at a given time point.

The Physician's Global Assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity". Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=10 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in Physician's Global Assessment of Disease Activity Baseline (n=10)	11.00 mm Standard Deviation 10.84
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 12 (n=10)	17.60 mm Standard Deviation 31.71
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 24 (n=9)	5.22 mm Standard Deviation 12.37
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 36 (n=9)	2.22 mm Standard Deviation 17.23
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 48 (n=9)	-4.11 mm Standard Deviation 7.10
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 60 (n=8)	-2.13 mm Standard Deviation 6.06
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 72 (n=8)	-0.75 mm Standard Deviation 7.87
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 84 (n=9)	1.22 mm Standard Deviation 9.80
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 96 (n=8)	2.00 mm Standard Deviation 19.25
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 108 (n=7)	1.00 mm Standard Deviation 6.90
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Week 120 (n=2)	2.5 mm Standard Deviation 7.78
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Completer last visit (n=7)	6.71 mm Standard Deviation 13.0
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Early withdrawal (n=2)	36.5 mm Standard Deviation 10.61
Change From Baseline in Physician's Global Assessment of Disease Activity Change at Last visit (n=9)	13.33 mm Standard Deviation 17.70

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Population: Safety population. Here, 'n' represents the number of participants available for assessment at a given time point.

Blood samples were collected for ESR, which is an acute phase reactant and provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=11 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in ESR Baseline (n=11)	5.82 mm/hr Standard Deviation 7.26
Change From Baseline in ESR Change at Week 12 (n=9)	-2.44 mm/hr Standard Deviation 8.34
Change From Baseline in ESR Change at Week 24 (n=9)	-3.11 mm/hr Standard Deviation 8.30
Change From Baseline in ESR Change at Week 36 (n=9)	1.89 mm/hr Standard Deviation 17.22
Change From Baseline in ESR Change at Week 48 (n=10)	0.90 mm/hr Standard Deviation 10.21
Change From Baseline in ESR Change at Week 60 (n=10)	-0.10 mm/hr Standard Deviation 12.64
Change From Baseline in ESR Change at Week 72 (n=10)	-2.60 mm/hr Standard Deviation 7.66
Change From Baseline in ESR Change at Week 84 (n=10)	2.80 mm/hr Standard Deviation 11.82
Change From Baseline in ESR Change at Week 96 (n=9)	-1.22 mm/hr Standard Deviation 9.97
Change From Baseline in ESR Change at Week 108 (n=7)	3.29 mm/hr Standard Deviation 21.34
Change From Baseline in ESR Change at Week 120 (n=2)	-0.50 mm/hr Standard Deviation 0.71
Change From Baseline in ESR Change at Completer last visit (n=9)	2.22 mm/hr Standard Deviation 6.55
Change From Baseline in ESR Change at Early withdrawal (n=2)	14.00 mm/hr Standard Deviation 15.56
Change From Baseline in ESR Change at Last visit (n=11)	4.36 mm/hr Standard Deviation 9.01

SECONDARY outcome

Timeframe: Baseline (Day 0), Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, completer last visit (up to Week 120), last visit (up to Week 120), early withdrawal (up to Week 120)

Blood samples were collected for CRP, which is an acute phase reactant and a measure of inflammation. Completer last visit: Last visit data for participants who completed the study. Last visit: Last visit data for all participants (including those who discontinued prematurely). Early withdrawal: Data at the time of early withdrawal for those participants who discontinued prematurely.

Outcome measures

Outcome measures
Measure	Tocilizumab n=5 Participants Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Change From Baseline in CRP Baseline (n=5)	0.49 milligrams per liter (mg/L) Standard Deviation 0.47
Change From Baseline in CRP Change at Week 12 (n=5)	1.07 milligrams per liter (mg/L) Standard Deviation 2.17
Change From Baseline in CRP Change at Week 24 (n=2)	-0.25 milligrams per liter (mg/L) Standard Deviation 0.35
Change From Baseline in CRP Change at Week 36 (n=3)	-0.02 milligrams per liter (mg/L) Standard Deviation 0.52
Change From Baseline in CRP Change at Week 48 (n=3)	-0.05 milligrams per liter (mg/L) Standard Deviation 0.65
Change From Baseline in CRP Change at Week 60 (n=3)	-0.09 milligrams per liter (mg/L) Standard Deviation 0.66
Change From Baseline in CRP Change at Week 72 (n=3)	-0.05 milligrams per liter (mg/L) Standard Deviation 0.61
Change From Baseline in CRP Change at Week 84 (n=3)	-0.05 milligrams per liter (mg/L) Standard Deviation 0.51
Change From Baseline in CRP Change at Week 96 (n=3)	-0.02 milligrams per liter (mg/L) Standard Deviation 0.62
Change From Baseline in CRP Change at Week 108 (n=3)	1.55 milligrams per liter (mg/L) Standard Deviation 2.13
Change From Baseline in CRP Change at Week 120 (n=0)	NA milligrams per liter (mg/L) Standard Deviation NA No participant was evaluable for the specified time point.
Change From Baseline in CRP Change at Completer last visit (n=3)	0.01 milligrams per liter (mg/L) Standard Deviation 0.54
Change From Baseline in CRP change at Early withdrawal (n=1)	4.79 milligrams per liter (mg/L) Standard Deviation NA Standard deviation data is not applicable since only 1 participant was evaluable at indicated time point.
Change From Baseline in CRP Change at Last visit (n=4)	1.21 milligrams per liter (mg/L) Standard Deviation 2.43

Adverse Events

Tocilizumab

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tocilizumab n=11 participants at risk Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Musculoskeletal and connective tissue disorders Osteonecrosis	9.1% 1/11 • Baseline up to approximately 142 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory pseudotumour	9.1% 1/11 • Baseline up to approximately 142 weeks
Vascular disorders Extremity necrosis	9.1% 1/11 • Baseline up to approximately 142 weeks

Other adverse events

Other adverse events
Measure	Tocilizumab n=11 participants at risk Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of \> 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
Infections and infestations Bronchitis	45.5% 5/11 • Baseline up to approximately 142 weeks
Infections and infestations Urinary tract infection	27.3% 3/11 • Baseline up to approximately 142 weeks
Infections and infestations Nasopharyngitis	18.2% 2/11 • Baseline up to approximately 142 weeks
Infections and infestations Rhinitis	18.2% 2/11 • Baseline up to approximately 142 weeks
Infections and infestations Sinusitis	18.2% 2/11 • Baseline up to approximately 142 weeks
Infections and infestations Gastroenteritis	9.1% 1/11 • Baseline up to approximately 142 weeks
Infections and infestations Influenza	9.1% 1/11 • Baseline up to approximately 142 weeks
Infections and infestations Oral herpes	9.1% 1/11 • Baseline up to approximately 142 weeks
Infections and infestations Tooth infection	9.1% 1/11 • Baseline up to approximately 142 weeks
Infections and infestations Vulvovaginal mycotic infection	9.1% 1/11 • Baseline up to approximately 142 weeks
Musculoskeletal and connective tissue disorders Arthralgia	36.4% 4/11 • Baseline up to approximately 142 weeks
Musculoskeletal and connective tissue disorders Muscle spasms	18.2% 2/11 • Baseline up to approximately 142 weeks
Musculoskeletal and connective tissue disorders Back pain	9.1% 1/11 • Baseline up to approximately 142 weeks
Musculoskeletal and connective tissue disorders Joint swelling	9.1% 1/11 • Baseline up to approximately 142 weeks
Musculoskeletal and connective tissue disorders Musculoskeletal pain	9.1% 1/11 • Baseline up to approximately 142 weeks
Musculoskeletal and connective tissue disorders Rheumatoid nodule	9.1% 1/11 • Baseline up to approximately 142 weeks
Musculoskeletal and connective tissue disorders Sjogren's syndrome	9.1% 1/11 • Baseline up to approximately 142 weeks
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	9.1% 1/11 • Baseline up to approximately 142 weeks
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Baseline up to approximately 142 weeks
Gastrointestinal disorders Constipation	9.1% 1/11 • Baseline up to approximately 142 weeks
Gastrointestinal disorders Dental caries	9.1% 1/11 • Baseline up to approximately 142 weeks
Gastrointestinal disorders Diarrhoea	9.1% 1/11 • Baseline up to approximately 142 weeks
Gastrointestinal disorders Gastrooesophageal reflux disease	9.1% 1/11 • Baseline up to approximately 142 weeks
Gastrointestinal disorders Nausea	9.1% 1/11 • Baseline up to approximately 142 weeks
Gastrointestinal disorders Radicular cyst	9.1% 1/11 • Baseline up to approximately 142 weeks
Eye disorders Dacryostenosis acquired	9.1% 1/11 • Baseline up to approximately 142 weeks
Eye disorders Eye pruritus	9.1% 1/11 • Baseline up to approximately 142 weeks
Eye disorders Ocular hyperaemia	9.1% 1/11 • Baseline up to approximately 142 weeks
General disorders General physical health deterioration	9.1% 1/11 • Baseline up to approximately 142 weeks
General disorders Injection site erythema	9.1% 1/11 • Baseline up to approximately 142 weeks
General disorders Pain	9.1% 1/11 • Baseline up to approximately 142 weeks
General disorders Pyrexia	9.1% 1/11 • Baseline up to approximately 142 weeks
Injury, poisoning and procedural complications Ligament sprain	9.1% 1/11 • Baseline up to approximately 142 weeks
Injury, poisoning and procedural complications Limb injury	9.1% 1/11 • Baseline up to approximately 142 weeks
Injury, poisoning and procedural complications Lip injury	9.1% 1/11 • Baseline up to approximately 142 weeks
Blood and lymphatic system disorders Thrombocytopenia	9.1% 1/11 • Baseline up to approximately 142 weeks
Investigations Scan abdomen abnormal	9.1% 1/11 • Baseline up to approximately 142 weeks
Metabolism and nutrition disorders Lipid metabolism disorder	9.1% 1/11 • Baseline up to approximately 142 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of spinal cord	9.1% 1/11 • Baseline up to approximately 142 weeks
Renal and urinary disorders Pyelocaliectasis	9.1% 1/11 • Baseline up to approximately 142 weeks
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.1% 1/11 • Baseline up to approximately 142 weeks
Skin and subcutaneous tissue disorders Rash pruritic	9.1% 1/11 • Baseline up to approximately 142 weeks
Surgical and medical procedures Tooth extraction	9.1% 1/11 • Baseline up to approximately 142 weeks

Additional Information

Medical Communications

Hoffmann-La Roche

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 only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER