A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting

CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01664104

Enrollment

151

Registered

2012-08-14

Start date

2012-06-30

Completion date

2013-12-31

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of tocilizumab therapy in a routine clinical practice in participants with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a maximum study duration of 18 months.

Interventions

DRUGTocilizumab

Tocilizumab will be administered in routine clinical practice in accordance with local label. Study protocol does not specify/enforce any treatment regimen.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of moderate to severe RA according to revised American College of Rheumatology criteria * Participants have started tocilizumab treatment according to routine clinical practice within 3 months prior to site opening and still in treatment, as well as participants who began treatment at enrollment

Exclusion criteria

* Participants who have started tocilizumab treatment more than 3 months prior to site opening * Participants who have previously received tocilizumab in a clinical trial setting or for compassionate use * Participants who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start * Participants with a history of autoimmune disease or joint inflammatory disease other than RA

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants on TCZ Treatment at Month 6	Month 6	Percentage of participants on TCZ treatment at Month 6 was calculated as: \[(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.

Secondary

Measure	Time frame	Description
Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline	Baseline	The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.
Percentage of Participants by TCZ Dose at Month 6	Month 6	TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the \[(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)\] multiplied by 100.
Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	Baseline	Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in IR to biologic group. Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the DMARDs intolerance and/or IR group.
Time Elapsed From Diagnosis of RA	Baseline (assessed retrospectively)	Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.
Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline	Baseline	Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.
Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline	Baseline	The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.
Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline	Baseline	The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.
Participant Assessment of Morning Stiffness Using VAS at Baseline	Baseline	The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.
Participant Assessment of Fatigue Using VAS at Baseline	Baseline	Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.
Tender Joint Count (TJC) at Baseline	Baseline	TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.
Erythrocyte Sedimentation Rate (ESR) at Baseline	Baseline	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.
C-Reactive Protein (CRP) at Baseline	Baseline	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline	Baseline	Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.
Percentage of Participants With Evidence of Structural Joint Damage at Baseline	Baseline	—
Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline	Baseline	—
Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline	Baseline	RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.
Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline	Baseline	—
Percentage of Participants by Duration of Morning Stiffness at Baseline	Baseline	Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (\<) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (\>) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.
Number of Participants With TCZ Dose Change According to the Reason for Change	Baseline up to Month 6	Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.
Percentage of Participants by Number of TCZ Dose Modifications Per Participant	Baseline up to Month 6	The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.
Time in Days Elapsed Between TCZ Infusions	Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8	The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.
Percentage of Participants With TCZ Infusion Interruption	Baseline up to Month 6	The percentage of participants with at least one infusion interruption was reported as Yes. Participants with unknown infusion interruption were set to No.
Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation	Baseline up to Month 6	—
Percentage of Participants With TCZ Reintroduction	Baseline up to Month 6	The percentage of participants with at least one TCZ reintroduction was reported as Yes. Participants with unknown TCZ reintroduction were set to No.
Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline	Baseline	—
Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6	Baseline, Month 3, and Month 6	DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of \< 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of \> 3.2 and ≤ 5.1 represents moderate disease activity and a score of \> 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6	Baseline, Month 3, and Month 6	SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and \> 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6	Baseline, Month 3, and Month 6	The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of \> 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline, Month 3, and Month 6	DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of \< 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of \>3.2 and ≤ 5.1 represents moderate disease activity, and a score of \> 5.1 represents high (or severe) disease activity.
Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline, Month 3, and Month 6	SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and \> 26.0 represents high (or severe) disease activity.
Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline, Month 3, and Month 6	CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of \> 22.0 represents high (or severe) disease activity.
Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3 and Month 6	ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.
Change From Baseline to Month 6 in TJC	Baseline and Month 6	TJC was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline and at Month 6. No tenderness = 0 and tenderness = 1.
Change From Baseline to Month 6 in SJC	Baseline and Month 6	SJC was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline and at Month 6. No swelling = 0 and swelling = 1.
Change From Baseline to Month 6 in PGH	Baseline and Month 6	The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.
Change From Baseline to Month 6 in PhGH	Baseline and Month 6	The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.
Change From Baseline to Month 6 in Patient's Assessment of Pain	Baseline and Month 6	Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.
Change From Baseline to Month 6 in HAQ-DI Score	Baseline and Month 6	The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.
Change From Baseline to Month 6 in Participant Assessment of Fatigue	Baseline and Month 6	Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.
Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness	Baseline and Month 6	The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.
Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI	Month 3 and Month 6	The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.
Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6	Month 3 and Month 6	Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of \>1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL \>1.2 with DAS28 score \> 3.2 to ≤ 5.1 or a chg from BL \> 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL \< 0.6 regardless initial DAS28 score or \> 0.6 to ≤ 1.2 with DAS28 score of \> 5.1.
Time to DMARD Dose Reduction	Baseline up to Month 6	DMARDs that met the criteria for concomitant medications were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered.
Time to DMARD Dose Withdrawal	Baseline up to Month 6	DMARDs that met the criteria for concomitant medications were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.
Percentage of Participants by Reason for DMARD Withdrawal During the Study	Baseline up to Month 6	DMARDs that met the criteria for concomitant medications were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected.
Time to Steroid Dose Reduction	Baseline up to Month 6	Steroids that met the criteria for concomitant medications were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered.
Time to Steroid Dose Withdrawal	Baseline up to Month 6	Steroids that met the criteria for concomitant medications were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.
Change From Baseline in CRP at Month 3 and Month 6	Baseline, Month 3, and Month 6	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
Change From Baseline in ESR at Month 3 and Month 6	Baseline, Month 3, and Month 6	ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.
CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6	Baseline	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of \< 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.
Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6	Baseline	DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of \< 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.
Percentage of Participants With and Without Morning Stiffness	Month 3 and Month 6	Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria: 1. Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present); 2. Duration of morning stiffness, measured by ticking 1 of the six categories: \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day; 3. Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.
Percentage of Participants by Duration of Morning Stiffness	Month 3 and Month 6	Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.
CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6	Baseline	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and \> 30 minutes.
Swollen Joint Count (SJC) at Baseline	Baseline	SJC was determined by examining 28 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline; no swelling = 0 and swelling = 1.
Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6	Baseline and Month 6	The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6	Baseline and Month 6	CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6	Baseline and Month 6	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6	Baseline and Month 6	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6	Baseline and Month 6	The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6	Baseline and Month 6	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6	Baseline and Month 6	Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.
BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6	Baseline	Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and \> 30 minutes.

Countries

Italy

Participant flow

Pre-assignment details

A total of 151 participants were enrolled in the study; of which,136 participants met the eligibility criteria. The results are reported only for those participants who met the eligibility criteria.

Participants by arm

Arm	Count
RA Participants Participants with moderate or severe RA who were under TCZ treatment in routine clinical practice (in accordance with the local label) were observed for 6 months from the start of treatment.	133
Total	133

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	6
Overall Study	Lack of Efficacy	2
Overall Study	Lost to Follow-up	4
Overall Study	Other	1
Overall Study	Unknown: Reason Unrelated to TCZ	2
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	RA Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 11
Sex: Female, Male Female	114 Participants
Sex: Female, Male Male	19 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	8 / 136
serious Total, serious adverse events	2 / 136

Outcome results

Primary

Percentage of Participants on TCZ Treatment at Month 6

Percentage of participants on TCZ treatment at Month 6 was calculated as: \[(participants on TCZ treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100. Confidence interval was computed based on the Clopper-Pearson method.

Time frame: Month 6

Population: All enrolled participants evaluable for primary objective.

Arm	Measure	Value (NUMBER)
RA Participants	Percentage of Participants on TCZ Treatment at Month 6	86.5 percentage of participants

Secondary

BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6

Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and \> 30 minutes.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6	Morning stiffness (≤ 30 minutes)	26.1 Kg/m^2	Standard Deviation 4
RA Participants	BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6	Morning stiffness (> 30 minutes)	26.6 Kg/m^2	Standard Deviation 5.9

p-value: 0.6159t-test

Secondary

Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6

DAS28 scale ranges from 0 to 10, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 and SJC28 = tender joint and swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, CRP = serum concentration of C-reactive protein. A score of \< 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100mm = extremely active arthritis. A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed = participants evaluable for this outcome measure and number analyzed = participants with available data for specified category.

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6	With DAS-28 CRP clinical remission	23.3 kilogram per meter square (Kg/m^2)	Standard Deviation 3.2
RA Participants	Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6	Without DAS-28 CRP clinical remission	26.7 kilogram per meter square (Kg/m^2)	Standard Deviation 5
RA Participants	Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6	With SDAI clinical remission	23.7 kilogram per meter square (Kg/m^2)	Standard Deviation 3.2
RA Participants	Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6	Without SDAI clinical remission	26.0 kilogram per meter square (Kg/m^2)	Standard Deviation 5
RA Participants	Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6	With CDAI clinical remission	23.8 kilogram per meter square (Kg/m^2)	Standard Deviation 3.3
RA Participants	Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6	Without CDAI clinical remission	26.6 kilogram per meter square (Kg/m^2)	Standard Deviation 5.8

p-value: 0.0018t-test

p-value: 0.1617t-test

p-value: 0.1296t-test

Secondary

Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6

The CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of \> 22.0 represents high (or severe) disease activity. Change from baseline = CDAI score at Month X - CDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.

Time frame: Baseline, Month 3, and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6	Baseline	30.48 units on a scale	Standard Deviation 13.62
RA Participants	Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6	Change at Month 3	15.06 units on a scale	Standard Deviation 13.56
RA Participants	Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6	Change at Month 6	15.96 units on a scale	Standard Deviation 15.73

p-value: <0.0001Wilcoxon test

Secondary

Change From Baseline in CRP at Month 3 and Month 6

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Change from baseline = CRP level at Month X - CRP level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.

Time frame: Baseline, Month 3, and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	Change From Baseline in CRP at Month 3 and Month 6	Change at Month 3	2.28 mg/dL	Standard Deviation 8.61
RA Participants	Change From Baseline in CRP at Month 3 and Month 6	Change at Month 6	1.98 mg/dL	Standard Deviation 8.87

p-value: <0.0001Wilcoxon test

Secondary

Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6

DAS28 score is a measurement of RA activity on a 0 to 10 scale, with higher scores representing higher disease activity, and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x natural logarithm (ln) (CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly (√ = square root). A score of \< 2.6 represents clinical remission, a score of greater than or equal to (≥) 2.6 and less than or equal to (≤) 3.2 represents low disease activity, a score of \> 3.2 and ≤ 5.1 represents moderate disease activity and a score of \> 5.1 represents high (or severe) disease activity. Change from baseline = DAS28 at Month X - DAS28 at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.

Time frame: Baseline, Month 3, and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6	Baseline	5.16 units on a scale	Standard Deviation 1.06
RA Participants	Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6	Change at Month 3	1.99 units on a scale	Standard Deviation 1.04
RA Participants	Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6	Change at Month 6	2.15 units on a scale	Standard Deviation 1.26

p-value: <0.0001Wilcoxon test

Secondary

Change From Baseline in ESR at Month 3 and Month 6

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A decrease in the level indicates reduction in inflammation and therefore improvement. Change from baseline = ESR level at Month X - ESR level at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.

Time frame: Baseline, Month 3, and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	Change From Baseline in ESR at Month 3 and Month 6	Change at Month 3	23.15 mm/hr	Standard Deviation 21.72
RA Participants	Change From Baseline in ESR at Month 3 and Month 6	Change at Month 6	21.42 mm/hr	Standard Deviation 23.21

p-value: <0.0001Wilcoxon test

Secondary

Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6

SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 = managing very well and 100 = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity , ≤ 26.0 represents moderate disease activity, and \> 26.0 represents high (or severe) disease activity. Change from baseline = SDAI score at Month X - SDAI score at baseline. Here X = 3 and 6 for Change at Months 3 and 6, respectively.

Time frame: Baseline, Month 3, and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6	Baseline	35.12 units on a scale	Standard Deviation 20.5
RA Participants	Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6	Change at Month 3	19.37 units on a scale	Standard Deviation 17.08
RA Participants	Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6	Change at Month 6	20.35 units on a scale	Standard Deviation 22

p-value: <0.0001Wilcoxon test

Secondary

Change From Baseline to Month 6 in HAQ-DI Score

The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do.Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for the primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Change From Baseline to Month 6 in HAQ-DI Score	0.4 units on a scale	Standard Deviation 0.6

Secondary

Change From Baseline to Month 6 in Participant Assessment of Fatigue

Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for the primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Change From Baseline to Month 6 in Participant Assessment of Fatigue	17.9 mm	Standard Deviation 23.1

Secondary

Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness

The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness	18.8 mm	Standard Deviation 31.6

Secondary

Change From Baseline to Month 6 in Patient's Assessment of Pain

Participants measured the pain intensity due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Change From Baseline to Month 6 in Patient's Assessment of Pain	22.5 mm	Standard Deviation 26.4

Secondary

Change From Baseline to Month 6 in PGH

The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well and 100 mm = managing very poorly.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for the primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Change From Baseline to Month 6 in PGH	21.4 mm	Standard Deviation 26.1

Secondary

Change From Baseline to Month 6 in PhGH

The PhGH was evaluated using a 100 mm VAS where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. Higher scores indicated increased level of disease.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for the primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Change From Baseline to Month 6 in PhGH	23.9 mm	Standard Deviation 26.2

Secondary

Change From Baseline to Month 6 in SJC

SJC was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at baseline and at Month 6. No swelling = 0 and swelling = 1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Change From Baseline to Month 6 in SJC	4.2 swollen joints	Standard Deviation 6.1

Secondary

Change From Baseline to Month 6 in TJC

TJC was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at baseline and at Month 6. No tenderness = 0 and tenderness = 1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Change From Baseline to Month 6 in TJC	6.0 tender joints	Standard Deviation 7.9

Secondary

Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6

The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6	Pearson correlation	0.08505 correlation coefficient
RA Participants	Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6	Spearman correlation	0.12488 correlation coefficient

p-value: 0.5655Pearson correlation

p-value: 0.3977Spearman Correlation

Secondary

Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6

Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6	Pearson correlation	0.00181 correlation coefficient
RA Participants	Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6	Spearman correlation	-0.07250 correlation coefficient

p-value: 0.9909Pearson correlation

p-value: 0.6482Spearman Correlation

Secondary

Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6	Pearson correlation	0.41875 correlation coefficient
RA Participants	Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6	Spearman correlation	0.40754 correlation coefficient

p-value: 0.0123Pearson correlation

p-value: 0.0151Spearman Correlation

Secondary

Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6

CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0= without any difficulty to 3= unable to do. Total score is the average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6	Pearson correlation	0.25513 correlation coefficient
RA Participants	Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6	Spearman correlation	0.21125 correlation coefficient

p-value: 0.0306Pearson correlation

p-value: 0.0749Spearman Correlation

Secondary

Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6	Pearson correlation	0.41350 correlation coefficient
RA Participants	Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6	Spearman correlation	0.40842 correlation coefficient

p-value: 0.0011Pearson correlation

p-value: 0.0013Spearman Correlation

Secondary

Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6

The test for CRP is laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in level of CRP indicates reduction in inflammation and therefore improvement. HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score is average of all questions, which ranges from 0 to 3, where higher scores represent higher disease activity. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6	Pearson correlation	0.12663 correlation coefficient
RA Participants	Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6	Spearman correlation	0.02678 correlation coefficient

p-value: 0.237Pearson correlation

p-value: 0.8033Spearman Correlation

Secondary

Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue. The Pearson and Spearman correlation coefficients can range in value from -1 to +1.

Time frame: Baseline and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6	Pearson correlation	0.08180 correlation coefficient
RA Participants	Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6	Spearman correlation	-0.11521 correlation coefficient

p-value: 0.4854Pearson correlation

p-value: 0.325S

Secondary

C-Reactive Protein (CRP) at Baseline

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	C-Reactive Protein (CRP) at Baseline	2.7 milligrams per deciliter (mg/dL)	Standard Deviation 7.9

Secondary

CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. The participant reported the duration of morning stiffness in the case report form by ticking the categories: ≤ 30 minutes and \> 30 minutes.

Time frame: Baseline

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6	Morning stiffness (≤ 30 minutes)	3.3 mg/dL	Standard Deviation 12
RA Participants	CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6	Morning stiffness (> 30 minutes)	2.1 mg/dL	Standard Deviation 2.9

p-value: 0.5332t-test

Secondary

CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. DAS28 is calculated as follows: DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, A score of \< 2.6 represents clinical remission. SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL). A SDAI score of ≤ 3.3 represents clinical remission. CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm). A CDAI score of ≤ 2.8 represents clinical remission.

Time frame: Baseline

Arm	Measure	Group	Value (MEAN)	Dispersion
RA Participants	CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6	With DAS28-CRP clinical remission	2.2 mg/dL	Standard Deviation 6.2
RA Participants	CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6	Without DAS28-CRP clinical remission	3.1 mg/dL	Standard Deviation 10.5
RA Participants	CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6	With SDAI clinical remission	4.6 mg/dL	Standard Deviation 10.6
RA Participants	CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6	Without SDAI clinical remission	2.8 mg/dL	Standard Deviation 9.5
RA Participants	CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6	With CDAI clinical remission	4.2 mg/dL	Standard Deviation 10
RA Participants	CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6	Without CDAI clinical remission	2.7 mg/dL	Standard Deviation 8.8

p-value: 0.6904t-test

p-value: 0.6032t-test

p-value: 0.6146t-test

Secondary

Erythrocyte Sedimentation Rate (ESR) at Baseline

ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter per hour (mm/hour). A decrease in the level indicates reduction in inflammation and therefore improvement.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Erythrocyte Sedimentation Rate (ESR) at Baseline	33.0 mm/hour	Standard Deviation 25.1

Secondary

Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline

The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life (QoL). 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all questions and ranges from 0 to 3, where higher scores represent higher disease activity.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline	1.4 units on a scale	Standard Deviation 0.6

Secondary

Number of Participants With TCZ Dose Change According to the Reason for Change

Number of participants with TCZ dose change (increase or decrease with respect to starting dose) was reported by reason for change.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for the primary objective and had TCZ dose modification.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Number of Participants With TCZ Dose Change According to the Reason for Change	Physician decision	1 participants
RA Participants	Number of Participants With TCZ Dose Change According to the Reason for Change	Weight variation	1 participants
RA Participants	Number of Participants With TCZ Dose Change According to the Reason for Change	Other	1 participants
RA Participants	Number of Participants With TCZ Dose Change According to the Reason for Change	Adverse event	3 participants

Secondary

Participant Assessment of Fatigue Using VAS at Baseline

Participants measured the level of fatigue due to RA using a 100 mm VAS, where the responses were on a continuous range from 0 mm = no fatigue to 100 mm = extreme fatigue.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Participant Assessment of Fatigue Using VAS at Baseline	57.1 mm	Standard Deviation 29

Secondary

Participant Assessment of Morning Stiffness Using VAS at Baseline

The participant assessment of morning stiffness was measured using a ruler on a 100 mm VAS, where the responses were on a continuous range from 0 mm = no stiffness and 100 mm = maximum stiffness.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Participant Assessment of Morning Stiffness Using VAS at Baseline	47.0 mm	Standard Deviation 32.6

Secondary

Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline

Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 mm = no pain to 100 mm = unbearable pain.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline	61.3 mm	Standard Deviation 28.2

Secondary

Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline

The PGH was measured using a 100 mm VAS, where the responses were on a continuous range from 0 mm = managing very well to 100 mm = managing very poorly.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline	61.0 mm	Standard Deviation 28.5

Secondary

Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6

Clinical response was assessed according to EULAR criteria that classified the participant according to individual changes in DAS28 score as good, moderate, or no response. DAS28 score is a measurement of RA activity on 0 to 10 scale and calculated as DAS28= 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28= tender joint count on 28 units, SJC28= swollen joint count on 28 units, CRP= serum concentration of C-reactive protein (after converting units to mg/dL), PGH= patient's global assessment of disease activity measured on a 100 mm VAS, where 0 mm= managing very well and 100 mm= managing very poorly. Good responders experienced change (chg) from baseline (BL) of \>1.2 with DAS28 score ≤ 3.2, moderate responders experienced chg from BL \>1.2 with DAS28 score \> 3.2 to ≤ 5.1 or a chg from BL \> 0.6 to ≤ 1.2 with DAS28 score of ≤ 5.1. No responders experienced chg from BL \< 0.6 regardless initial DAS28 score or \> 0.6 to ≤ 1.2 with DAS28 score of \> 5.1.

Time frame: Month 3 and Month 6

Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6	Month 3: Good response	41.3 percentage of participants
RA Participants	Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6	Month 3: Moderate response	47.8 percentage of participants
RA Participants	Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6	Month 3: No response	10.9 percentage of participants
RA Participants	Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6	Month 6: Good response	45.5 percentage of participants
RA Participants	Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6	Month 6: Moderate response	40.9 percentage of participants
RA Participants	Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6	Month 6: No response	13.6 percentage of participants

Secondary

Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6

CDAI is a combined index for measuring disease activity in RA and calculated as CDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, and PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = no arthritis activity and 100 mm = extremely active arthritis. CDAI total score ranged from 0-76. Higher scores indicate greater disease activity. CDAI score of ≤ 2.8 represents clinical remission, score of ≤ 10.0 represents low disease activity, score of ≤ 22.0 represents moderate disease activity, and score of \> 22.0 represents high (or severe) disease activity.

Time frame: Baseline, Month 3, and Month 6

Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for the outcome measure and number analyzed = participants with available data for specified category.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: CDAI ≤ 2.8	2.1 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: CDAI ≤ 10.0	8.2 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: CDAI ≤ 22.0	24.7 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: CDAI > 22.0	75.3 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: CDAI ≤ 2.8	7.4 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: CDAI ≤ 10.0	36.2 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: CDAI ≤ 22.0	77.7 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: CDAI > 22.0	22.3 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: CDAI ≤ 2.8	10.6 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: CDAI ≤ 10.0	42.6 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: CDAI ≤ 22.0	78.7 percentage of participants
RA Participants	Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: CDAI > 22.0	21.3 percentage of participants

Secondary

Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6

DAS28 score is a measurement of RA activity on a 0 to 10 scale and calculated as DAS28 = 0.56 x √TJC28 + 0.28 x √SJC28 + 0.36 x ln(CRP + 1) + 0.014 x PGH + 0.96, where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, CRP = serum concentration of c-reactive protein (after converting units to mg/dL), PGH = patient's global assessment of disease activity, which was measured on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly. Higher scores represent greater disease activity. A score of \< 2.6 represents clinical remission, a score of ≥ 2.6 and ≤ 3.2 represents low disease activity, a score of \>3.2 and ≤ 5.1 represents moderate disease activity, and a score of \> 5.1 represents high (or severe) disease activity.

Time frame: Baseline, Month 3, and Month 6

Population: All enrolled participants evaluable for primary objective. Here, Number of participants analyzed= participants evaluable for this outcome and number analyzed = participants with available data for specified category.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: DAS28 < 2.6	3.5 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: DAS28 ≥ 2.6 to ≤ 3.2	1.8 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: DAS28 > 3.2 to ≤ 5.1	43.9 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: DAS28 > 5.1	50.9 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: DAS28 < 2.6	30.4 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: DAS28 ≥ 2.6 to ≤ 3.2	14.1 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: DAS28 >3.2 to ≤ 5.1	50.0 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: DAS28 > 5.1	5.4 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: DAS28 < 2.6	33.7 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: DAS28 ≥ 2.6 to ≤ 3.2	15.1 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: DAS28 >3.2 to ≤ 5.1	43.0 percentage of participants
RA Participants	Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: DAS28 > 5.1	8.1 percentage of participants

Secondary

Percentage of Participants by Duration of Morning Stiffness

Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.

Time frame: Month 3 and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 3 (no morning stiffness)	15.8 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 6 (no morning stiffness)	25.8 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 3 (< 30 minutes)	40.8 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 6 (< 30 minutes)	35.0 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 3 (between 30 - 60 minutes )	20.0 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 6 (between 30 - 60 minutes)	21.7 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 3 (Between 60 - 240 minutes)	7.5 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 6 (Between 60 - 240 minutes)	7.5 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 3 (> 240 minutes)	0.8 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 6 (> 240 minutes)	0 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 3 (whole day)	0 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 6 (whole day)	0.8 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 3 (not estimable)	11.7 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 6 (not estimable)	9.2 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness	Month 3 (not done)	3.3 percentage of participants

Secondary

Percentage of Participants by Duration of Morning Stiffness at Baseline

Duration of morning stiffness was defined as the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant reported the duration of morning stiffness in the case report form by ticking 1 of the following categories: no morning stiffness, less than (\<) 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, greater than (\>) 240 minutes, and the whole day. 'Not estimable' represented that the participants were not able to quantify it.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by Duration of Morning Stiffness at Baseline	No morning stiffness	6.8 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness at Baseline	< 30 minutes	15.0 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness at Baseline	Between 30 - 60 minutes	30.1 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness at Baseline	Between 60 - 120 minutes	25.6 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness at Baseline	Between 120 - 240 minutes	4.5 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness at Baseline	> 240 minutes	3.8 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness at Baseline	The whole day	2.3 percentage of participants
RA Participants	Percentage of Participants by Duration of Morning Stiffness at Baseline	Not estimable	12.0 percentage of participants

Secondary

Percentage of Participants by Number of TCZ Dose Modifications Per Participant

The number of TCZ dose modifications per participant was calculated as the number of times that the participant changed the prescribed dose with respect to the dose planned at enrollment/previous administration. If the participant did not change the prescribed dose, the values were set at missing.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by Number of TCZ Dose Modifications Per Participant	0 dose modification	95.49 percentage of participants
RA Participants	Percentage of Participants by Number of TCZ Dose Modifications Per Participant	1 dose modification	1.50 percentage of participants
RA Participants	Percentage of Participants by Number of TCZ Dose Modifications Per Participant	2 dose modifications	3.01 percentage of participants

Secondary

Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline	DMARD intolerability	85 percentage of participants
RA Participants	Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline	Both lack of efficacy and intolerability to DMARDs	2.5 percentage of participants
RA Participants	Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline	Lack of DMARD efficacy	12.5 percentage of participants

Secondary

Percentage of Participants by Reason for DMARD Withdrawal During the Study

DMARDs that met the criteria for concomitant medications were selected. All treatments with DMARDs interrupted after the first TCZ infusion were selected.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by Reason for DMARD Withdrawal During the Study	Lack of efficacy	18.18 percentage of participants
RA Participants	Percentage of Participants by Reason for DMARD Withdrawal During the Study	Subjective intolerance	9.09 percentage of participants
RA Participants	Percentage of Participants by Reason for DMARD Withdrawal During the Study	Objective intolerance	36.36 percentage of participants
RA Participants	Percentage of Participants by Reason for DMARD Withdrawal During the Study	Unspecified	36.36 percentage of participants

Secondary

Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6

SDAI is a combined index for measuring disease activity in RA and calculated as SDAI = TJC28 + SJC28 + PGH (in cm) + PhGH (in cm) + CRP (in mg/dL), where TJC28 = tender joint count on 28 units, SJC28 = swollen joint count on 28 units, PGH = patient's global assessment of disease activity, assessed on a 100 mm VAS, where 0 mm = managing very well and 100 mm = managing very poorly, PhGH = physician global assessment of disease activity, assessed on a 100 mm VAS, where 0 = no arthritis activity and 100 = extremely active arthritis, CRP = serum concentration of C-reactive protein. SDAI total score ranged from 0-86. Higher scores represent greater disease activity. SDAI scores of ≤ 3.3 represents clinical remission, ≤ 11.0 represents low disease activity, ≤ 26.0 represents moderate disease activity, and \> 26.0 represents high (or severe) disease activity.

Time frame: Baseline, Month 3, and Month 6

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: SDAI ≤ 3.3	2.2 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: SDAI ≤ 11.0	7.5 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: SDAI ≤ 26.0	36.6 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Baseline: SDAI > 26.0	63.4 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: SDAI ≤ 3.3	7.2 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: SDAI ≤ 11.0	34.9 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: SDAI ≤ 26.0	80.7 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 3: SDAI > 26.0	19.3 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: SDAI ≤ 3.3	13.8 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: SDAI ≤ 11.0	47.5 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: SDAI ≤ 26.0	82.5 percentage of participants
RA Participants	Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6	Month 6: SDAI > 26.0	17.5 percentage of participants

Secondary

Percentage of Participants by TCZ Dose at Month 6

TCZ dose at Month 6 was calculated over the total number of participants evaluable for the primary objective and who did not interrupt TCZ. Percentage of participants on TCZ dose at Month 6 was calculated as the \[(participants with specified TCZ dose at 6 months) divided by (participants who did not interrupt TCZ at Month 6)\] multiplied by 100.

Time frame: Month 6

Population: All enrolled participants evaluable for primary objective and who did not interrupt TCZ at Month 6.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants by TCZ Dose at Month 6	8 milligrams per kilogram (mg/kg)	93.91 percentage of participants
RA Participants	Percentage of Participants by TCZ Dose at Month 6	4 mg/kg	1.74 percentage of participants
RA Participants	Percentage of Participants by TCZ Dose at Month 6	6.35 mg/kg	0.87 percentage of participants
RA Participants	Percentage of Participants by TCZ Dose at Month 6	7.6 mg/kg	0.87 percentage of participants
RA Participants	Percentage of Participants by TCZ Dose at Month 6	6.4 mg/kg	0.87 percentage of participants
RA Participants	Percentage of Participants by TCZ Dose at Month 6	Not available	0.87 percentage of participants
RA Participants	Percentage of Participants by TCZ Dose at Month 6	7.1 mg/kg	0.87 percentage of participants

Secondary

Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Participants with at least 1 treatment with biologic agent not equal missing and which is not ongoing or with a stop date lower or equal to first TCZ administration had IR to biologic treatment. Participants with at least 1 treatment with DMARDs with a stop date lower or equal to first TCZ administration had IR to DMARDs. Participants with a biologic and DMARDs interruption or with a biologic interruption and ongoing treatment with DMARDs were classified in IR to biologic group. Participants with DMARDs interruption or ongoing DMARDs and adding TCZ without a biologic interruption were classified in the DMARDs intolerance and/or IR group.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	IR to biologic treatment	62.4 percentage of participants
RA Participants	Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	Intolerance or IR to DMARDs	37.6 percentage of participants

Secondary

Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective who discontinued TCZ.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation	Adverse event	50.0 percentage of participants
RA Participants	Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation	Lack of or insufficient efficacy	33.33 percentage of participants
RA Participants	Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation	Unspecified	16.67 percentage of participants

Secondary

Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment

ACR20, 50, 70 or 90 response = an improvement of ≥20%, ≥50%, ≥70% or ≥90% respectively, as compared to baseline in TJC28 and SJC28, and 20/50/70/90%, improvement in at least 3 of 5 following measures: Patient's Assessment of Pain over previous 24 hours, PGH, PhGH, HAQ, and acute phase reactant (either CRP or ESR). TJC and SJC, based on 28-joint assessments. Number of tender joints and swollen joints were recorded on joint assessment form at baseline; no tenderness = 0 and tenderness = 28, no swelling = 0 and swelling = 28, respectively. HAQ measures functional status (disability) and health-related QoL with 20 questions, summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip and common activities over past week, 0= without difficulty to 3= unable to do. Patient's assessment of pain assessed using VAS; 0 mm = no pain, 100 mm = unbearable pain; PGH and PhGH, assessed using VAS; 0 mm = no disease activity, 100 mm = maximum disease activity.

Time frame: Month 3 and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 20 achieved	45 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 20 not achieved	38.3 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 20 at least 1 missing data	16.7 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 50 achieved	23.3 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 50 not achieved	62.5 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 50 at least 1 missing data	14.2 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 70 achieved	9.2 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 70 not achieved	79.2 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 70 at least 1 missing data	11.7 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 90 achieved	1.7 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 90 not achieved	90.0 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 3: ACR 90 at least 1 missing data	8.3 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 20 achieved	51.7 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 20 not achieved	35.8 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 20 at least 1 missing data	12.5 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 50 achieved	27.5 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 50 not achieved	57.5 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 50 at least 1 missing data	15.0 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 70 achieved	12.5 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 70 not achieved	73.3 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 70 at least 1 missing data	14.2 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 90 achieved	2.5 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 90 not achieved	89.2 percentage of participants
RA Participants	Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment	Month 6: ACR 90 at least 1 missing data	8.3 percentage of participants

Secondary

Percentage of Participants With and Without Morning Stiffness

Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. The participant assessed morning stiffness based on the following criteria: 1. Presence of participant's joints stiff when woke up that day, measured as yes (stiffness present) or no (stiffness not present); 2. Duration of morning stiffness, measured by ticking 1 of the six categories: \< 30 minutes, 30 - 60 minutes, 60 - 120 minutes, 120 - 240 minutes, \> 240 minutes, and the whole day; 3. Severity of morning stiffness measured using a ruler on a 100 mm VAS where the responses were on a continuous range from 0 mm = no stiffness to 100 mm = maximum stiffness. 'Not estimable' represented that the participants were not able to quantify it. 'Not done' represented that the assessment was not performed.

Time frame: Month 3 and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants With and Without Morning Stiffness	Month 3 (morning stiffness not estimable)	10.8 percentage of participants
RA Participants	Percentage of Participants With and Without Morning Stiffness	Month 3 (with morning stiffness)	70.0 percentage of participants
RA Participants	Percentage of Participants With and Without Morning Stiffness	Month 3 (without morning stiffness)	15.8 percentage of participants
RA Participants	Percentage of Participants With and Without Morning Stiffness	Month 3 (morning stiffness not done)	3.3 percentage of participants
RA Participants	Percentage of Participants With and Without Morning Stiffness	Month 6 (with morning stiffness)	65.0 percentage of participants
RA Participants	Percentage of Participants With and Without Morning Stiffness	Month 6 (without morning stiffness)	25.8 percentage of participants
RA Participants	Percentage of Participants With and Without Morning Stiffness	Month 6 (morning stiffness not estimable)	9.2 percentage of participants

Secondary

Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (NUMBER)
RA Participants	Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline	58.3 percentage of participants

Secondary

Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI

The HAQ-DI is a questionnaire that measures functional status (disability) and health-related QoL. 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 was evaluated according to the degree of severity on a 4-point scale ranging from 0 = without any difficulty to 3 = unable to do. Total score for HAQ-DI is the average of all the questions, which ranges from 0 to 3, where higher scores represent higher disease activity. HAQ-DI clinically meaningful improvement is defined as decrease in HAQ total score from baseline of greater or equal to 0.22 points.

Time frame: Month 3 and Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI	Month 3	36.7 percentage of participants
RA Participants	Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI	Month 6	45.8 percentage of participants

Secondary

Percentage of Participants With Evidence of Structural Joint Damage at Baseline

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (NUMBER)
RA Participants	Percentage of Participants With Evidence of Structural Joint Damage at Baseline	71.9 percentage of participants

Secondary

Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline

RF is the auto antibody directed against immunoglobulin G and its concentration is observed in human serum or plasma. RF value higher than 20 units per milliliter is considered positive.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (NUMBER)
RA Participants	Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline	59.5 percentage of participants

Secondary

Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline

Extra-articular systemic features referred to anemia, fatigue as well as a wide range of co-morbidities such as osteoporosis and other iatrogenic complications. Percentage of participants with any of the extra-articular systemic feature are reported.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (NUMBER)
RA Participants	Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline	7.0 percentage of participants

Secondary

Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (NUMBER)
RA Participants	Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline	12.9 percentage of participants

Secondary

Percentage of Participants With TCZ Infusion Interruption

The percentage of participants with at least one infusion interruption was reported as Yes. Participants with unknown infusion interruption were set to No.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants With TCZ Infusion Interruption	Yes	3.01 percentage of participants
RA Participants	Percentage of Participants With TCZ Infusion Interruption	No	96.99 percentage of participants

Secondary

Percentage of Participants With TCZ Reintroduction

The percentage of participants with at least one TCZ reintroduction was reported as Yes. Participants with unknown TCZ reintroduction were set to No.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective.

Arm	Measure	Group	Value (NUMBER)
RA Participants	Percentage of Participants With TCZ Reintroduction	Yes	1.5 percentage of participants
RA Participants	Percentage of Participants With TCZ Reintroduction	No	98.5 percentage of participants

Secondary

Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline

The PhGH was measured on a 100 mm VAS, where 0 mm = no arthritis activity to 100 mm = extremely active arthritis.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline	53.4 mm	Standard Deviation 24.6

Secondary

Swollen Joint Count (SJC) at Baseline

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

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Swollen Joint Count (SJC) at Baseline	6.7 swollen joints	Standard Deviation 5.5

Secondary

Tender Joint Count (TJC) at Baseline

TJC was determined by examining 28 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline; no tenderness = 0 and tenderness = 1.

Time frame: Baseline

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEAN)	Dispersion
RA Participants	Tender Joint Count (TJC) at Baseline	11.5 tender joints	Standard Deviation 7.5

Secondary

Time Elapsed From Diagnosis of RA

Time elapsed from diagnosis of RA in years was calculated as the (difference between the date of enrollment visit and the date of first diagnosis of RA) divided by 365.25.

Time frame: Baseline (assessed retrospectively)

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEDIAN)
RA Participants	Time Elapsed From Diagnosis of RA	6.5 years

Secondary

Time in Days Elapsed Between TCZ Infusions

The time elapsed in days between TCZ infusions was calculated as the difference between the date of TCZ infusion and the date of the previous administration.

Time frame: Baseline up to Month 6 (assessed retrospectively and prospectively at each administration [approximately 1 month apart] up to administration 8

Arm	Measure	Group	Value (MEDIAN)
RA Participants	Time in Days Elapsed Between TCZ Infusions	Infusion 1 and Infusion 2	31 days
RA Participants	Time in Days Elapsed Between TCZ Infusions	Infusion 2 and Infusion 3	31.5 days
RA Participants	Time in Days Elapsed Between TCZ Infusions	Infusion 3 and Infusion 4	31 days
RA Participants	Time in Days Elapsed Between TCZ Infusions	Infusion 4 and Infusion 5	30 days
RA Participants	Time in Days Elapsed Between TCZ Infusions	Infusion 5 and Infusion 6	31 days
RA Participants	Time in Days Elapsed Between TCZ Infusions	Infusion 6 and Infusion 7	29 days
RA Participants	Time in Days Elapsed Between TCZ Infusions	Infusion 7 and Infusion 8	28 days

Secondary

Time to DMARD Dose Reduction

DMARDs that met the criteria for concomitant medications were selected. The time to DMARD dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than 1 DMARD dose reduction, only the first dose reduction was considered.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEDIAN)
RA Participants	Time to DMARD Dose Reduction	3.2 months

Secondary

Time to DMARD Dose Withdrawal

DMARDs that met the criteria for concomitant medications were selected. The time to DMARD withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEDIAN)
RA Participants	Time to DMARD Dose Withdrawal	4.1 months

Secondary

Time to Steroid Dose Reduction

Steroids that met the criteria for concomitant medications were selected. The time to steroid dose reduction was calculated as the difference between date of dose reduction and the date of first TCZ infusion. For participants presenting more than one steroid dose reduction, only the first dose reduction was considered.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEDIAN)
RA Participants	Time to Steroid Dose Reduction	2.3 months

Secondary

Time to Steroid Dose Withdrawal

Steroids that met the criteria for concomitant medications were selected. The time to steroid dose withdrawal was calculated as the difference between date of withdrawal and the date of first TCZ infusion.

Time frame: Baseline up to Month 6

Population: All enrolled participants evaluable for primary objective with available data for this outcome measure.

Arm	Measure	Value (MEDIAN)
RA Participants	Time to Steroid Dose Withdrawal	1.8 months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants on TCZ Treatment at Month 6

BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6

Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6

Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6

Change From Baseline in CRP at Month 3 and Month 6

Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6

Change From Baseline in ESR at Month 3 and Month 6

Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6

Change From Baseline to Month 6 in HAQ-DI Score

Change From Baseline to Month 6 in Participant Assessment of Fatigue

Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness

Change From Baseline to Month 6 in Patient's Assessment of Pain

Change From Baseline to Month 6 in PGH

Change From Baseline to Month 6 in PhGH

Change From Baseline to Month 6 in SJC

Change From Baseline to Month 6 in TJC

Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6

Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6

Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6

Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6

Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6

Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6

Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6

C-Reactive Protein (CRP) at Baseline

CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6

CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6

Erythrocyte Sedimentation Rate (ESR) at Baseline

Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline

Number of Participants With TCZ Dose Change According to the Reason for Change

Participant Assessment of Fatigue Using VAS at Baseline

Participant Assessment of Morning Stiffness Using VAS at Baseline

Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline

Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline

Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6

Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6

Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6

Percentage of Participants by Duration of Morning Stiffness

Percentage of Participants by Duration of Morning Stiffness at Baseline

Percentage of Participants by Number of TCZ Dose Modifications Per Participant

Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline

Percentage of Participants by Reason for DMARD Withdrawal During the Study

Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6

Percentage of Participants by TCZ Dose at Month 6

Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation

Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment

Percentage of Participants With and Without Morning Stiffness

Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline

Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI

Percentage of Participants With Evidence of Structural Joint Damage at Baseline

Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline

Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline

Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline

Percentage of Participants With TCZ Infusion Interruption

Percentage of Participants With TCZ Reintroduction

Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline

Swollen Joint Count (SJC) at Baseline

Tender Joint Count (TJC) at Baseline

Time Elapsed From Diagnosis of RA