A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

The VAS for Fatigue (VAS-F) consists of a 100 mm line, with 0 (No Fatigue) on one end, and 100 (Extreme Fatigue) on the other end, which a participant marks to indicate how much fatigue he or she feels. The marked point in mm is converted into a numeric value from 0 to 100, where 0=no fatigue and 100=maximum fatigue. Increasing numbers=increasing fatigue.

Time frame: Up to 1 year

Population: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.

The FACIT-Fatigue score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).

Time frame: Up to 1 year

Population: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.

The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]), and general health status (participant global assessment of disease activity using visual analog scale \[VAS\], range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Time frame: Up to 1 year

Population: The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.

DAS28 Clinically Significant Improvement was defined as a DAS28 score reduction of at least 1.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Time frame: Up to 1 year

Population: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.

Health Assessment Questionnaire (HAQ) is a self-completed participant questionnaire specific for Rheumatoid Arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. To calculate HAQ, the participant must have a domain score for at least 6 out of 8 domains. The HAQ is the sum of the scores, divided by the number of domains that have a score (in range 6-8) for a total possible score minimum/maximum 0 (best) to 3 (worst). A negative change from baseline indicated improvement. Clinically meaningful HAQ response was defined as an improvement of at least 0.22 units from baseline in the HAQ Disability Index.

Time frame: Up to 1 year

Population: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.

DAS28 low disease activity was defined as a DAS28 score reduction of at least 3.2 units from Baseline. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Time frame: Up to 1 year

Population: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.

The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Time frame: Up to 1 year

Population: ITT consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.

Time to DAS28 Remission was the Time in days from the first infusion of study drug to the achievement of a DAS28 score \< 2.6 units. The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm). DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.

Time frame: Up to 1 year

Population: The intent-to-treat population (ITT) consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' is equal to (=) number of participants analyzed at particular point of time.

ACR20, ACR50, ACR70, and ACR90 are defined as greater than or equal to (≥)20 percent (%), ≥50%, ≥70%, or ≥90% improvement, respectively, in swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints). It also comprises ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of the following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein \[CRP\]).

Time frame: Up to 1 year

Population: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.

It included participants who discontinued from the study due to occurrence of AE or SAE.

Time frame: Up to 1 year

Population: Safety population included all participants who had received at least one dose of study medication.

An adverse event (AE) is defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is a significant medical event.

Time frame: Up to 1 year

Population: Safety population included all participants who had received at least one dose of study medication.

CRP is a biological marker of inflammation. A reduction in CRP indicates improvement. It is measured in milligram per liter (mg/L).

Time frame: Up to 1 year

Population: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.

ESR is an acute phase reactant and is a measure of inflammation. It is measured in millimeter per hour (mm/hr).

Time frame: Up to 1 year

Population: ITT population consisted of all consented participants enrolled in the study, who had received any part of an infusion of study medication. Where, 'n' = number of participants analyzed at particular point of time.