A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01462162
• Collaborator: (none)
• Enrollment: 122
• Locations: 16
• Duration (Months): 26
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 months.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Tocilizumab

Study Design

• Study Type: Observational
• Actual Enrollment: 122 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical Practice
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Rheumatoid Arthritis Participants Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center will be followed-up for 6 months.	Drug: Tocilizumab; Other Names: RoActemra Actemra

Outcome Measures

Primary Outcome Measures

1. Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12 [Week 12]

   Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.

2. Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24 [Week 24]

   Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.

Secondary Outcome Measures

1. Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F [Baseline, Week 12, Week 24]

   FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).

2. Change From Baseline to Week 12 and 24 in Serum Hemoglobin [Baseline, Week 12, 24]

   The hemoglobin level was measured in grams per liter (g/L). Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

3. Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 [Week 12, 24]

   Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), serum hemoglobin, swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.

4. Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 [Week 12, 24]

   Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.

5. Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population [Week 12, 24]

   Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.

6. Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population [Week 12, 24]

   Regression analysis between the change in hemoglobin level and number of swollen joints was evaluated. Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.

7. Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 [Baseline, Week 12, Week 24]

   Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

8. Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population [Baseline, Week 12, 24]

   Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

9. Change From Baseline in Duration of Morning Stiffness at Week 12, 24 [Baseline, Week 12, 24]

   Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

10. Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population [Baseline, Week 12, 24]

    Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

11. Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 [Baseline, Week 12, 24]

    Change from Baseline in 10 centimeter (cm) VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

12. Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population [Baseline, Week 12, 24]

    Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

13. Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 [Baseline, Week 12, 24]

    Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

14. Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population [Baseline, Week 12, 24]

    Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

15. Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 [Baseline, Week 12, 24]

    Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.

16. Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population [Baseline, Week 12, 24]

    Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

17. Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 [Baseline, Week 12, 24]

    DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and tender joint count (TJC) using 28 joints count, ESR millimeter per hour (mm/hr) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) less than (<)2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.

18. Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population [Baseline, Week 12, 24]

    DAS28-4 ESR was calculated from SJC and TJC using 28 joints count, ESR mm/hr and PtGA of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.

19. Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 [Week 12, 24]

    Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.

20. Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population [Week 12, 24]

    Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab according to his/her clinical judgment and the conditions approved in the Summary of Product Characteristics (SPC).

Exclusion Criteria:

• Participants previously or currently treated with RoActemra/Actemra in clinical trials

• Absolute neutrophil count less than or equal to (</=) 2x10^9 per liter (/L)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Hospitalet de Llobregat	Barcelona	Spain	08906
2		Mollet del Valles	Barcelona	Spain	08100
3		Sabadell	Barcelona	Spain	08208
4		Sant Joan Despi	Barcelona	Spain	08970
5		A Coruña	La Coruña	Spain	15405
6		Cartagena	Murcia	Spain	30203
7		El Palmar	Murcia	Spain	30120
8		Lorca	Murcia	Spain	30800
9		Ourense	Orense	Spain	32005
10		Vigo	Pontevedra	Spain	36204
11		Barcelona		Spain	08035
12		Barcelona		Spain	08907
13		Girona		Spain	17002
14		Lugo		Spain	27880
15		Tarragona		Spain	43003
16		Tarragona		Spain	43204

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01462162
• Other Study ID Numbers: ML27833
• First Posted: Oct 31, 2011
• Last Update Posted: Oct 31, 2016
• Last Verified: Sep 1, 2016

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

Participant Flow

Recruitment Details	Total of 122 participants were recruited, 2 participants were excluded from analysis, one due to non-compliance with the inclusion criteria and other due to compliance with the exclusion criteria.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
Period Title: Overall Study
STARTED	120
COMPLETED	108
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
Overall Participants	120
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.2 (12.6)
Sex: Female, Male (Count of Participants)
Female	104 86.7%
Male	16 13.3%

Outcome Measures

1. Primary Outcome

Title	Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12
Description	Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population included all participants who had all measurements of effectiveness and had complete information of the FACIT questionnaire throughout the study. Here, Number of participants analyzed (N) = number of participants evaluable for this measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	65
DAS-28	-2.200
Sleepiness	-0.944
Depression	-0.707

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score versus change in DAS-28 score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score versus change in sleepiness score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score versus change in depression score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	Regression, Linear
	Comments

2. Primary Outcome

Title	Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24
Description	Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. Here, N=number of participants evaluable for this measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	71
DAS-28	-1.743
Sleepiness	-0.990
Depression	-0.658

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score versus change in DAS-28 score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score versus change in sleepiness score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score versus change in depression score
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	Regression, Linear
	Comments

3. Secondary Outcome

Title	Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F
Description	FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (not at all) to 4 (very much). Larger the participant's response to the questions (with the exception of 2 negatively stated), greater was the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
Time Frame	Baseline, Week 12, Week 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	85
Baseline	26.8 (12.4)
Change at Week 12	4.6 (10.4)
Change at Week 24	5.4 (11.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Change From Baseline to Week 12 and 24 in Serum Hemoglobin
Description	The hemoglobin level was measured in grams per liter (g/L). Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants for each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	73
Baseline for Week 12 (n=70)	12.3 (1.4)
Change at Week 12 (n=70)	0.7 (1.2)
Baseline for Week 24 (n=73)	12.4 (1.5)
Change at Week 24 (n=73)	0.56 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

Title	Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24
Description	Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), serum hemoglobin, swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.
Time Frame	Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. Here, N=number of participants analyzed for this measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	84
DAS-28 (Week 12)	-3.241
DAS-28 (Week 24)	-2.596
Serum hemoglobin (Week 12)	0.335
Serum hemoglobin (Week 24)	-0.242
Swollen joint count (Week 12)	-0.333
Swollen joint count (Week 24)	-0.600
Morning stiffness (Week 12)	-0.559
Morning stiffness (Week 24)	-0.718
Degree of pain (Week 12)	-0.947
Degree of pain (Week 24)	-0.839
Sleepiness (Week 12)	-0.742
Sleepiness (Week 24)	1.193
Depression (Week 12)	-0.714
Depression (Week 24)	-0.777

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 12 versus change in DAS-28 at Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 24 versus change in DAS-28 at Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.006
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 12 versus change in serum hemoglobin Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.791
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 24 versus change in serum hemoglobin Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.847
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 12 versus change in swollen joint count Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.182
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 24 versus change in swollen joint count Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 12 versus change in morning stiffness Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.163
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 24 versus change in morning stiffness Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.115
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 12 versus change in degree of pain Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.037
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 24 versus change in degree of pain Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.044
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 12 versus change in sleepiness at Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 24 versus change in sleepiness at Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 12 versus change in depression Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in fatigue score at Week 24 versus change in depression at Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments

6. Secondary Outcome

Title	Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24
Description	Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.
Time Frame	Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. N=number of participants analyzed for this measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	73
Swollen joint count (Week 12)	-0.011
Swollen joint count (Week 24)	0.028
Morning stiffness (Week 12)	0.017
Morning stiffness (Week 24)	-0.055
Degree of pain (Week 12)	0.021
Degree of pain (Week 24)	0.013
Sleepiness (Week 12)	0.004
Sleepiness (Week 24)	0.062
Depression (Week 12)	-0.016
Depression (Week 24)	-0.007

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in swollen joint count (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.678
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in swollen joint count (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.348
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in morning stiffness (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.679
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in morning stiffness (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.556
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in haemoglobin levels versus change in degree of pain (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.692
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in haemoglobin levels versus change in degree of pain (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.771
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in haemoglobin levels versus change in sleepiness (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.878
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in haemoglobin levels versus change in sleepiness (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.139
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in haemoglobin levels versus change in depression score (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.249
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in depression score (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.610
	Comments
	Method	Regression, Linear
	Comments

7. Secondary Outcome

Title	Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population
Description	Regression analysis between change in hemoglobin level and change in following variable were assessed: Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression), swollen joint count, morning stiffness (time taken to achieve maximum improvement), degree of pain (assessed on horizontal visual scale, 0=no pain; 10=maximum pain). Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.
Time Frame	Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety analysis population. Here, N=number of participants analyzed for this measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	84
Swollen joint count (Week 12)	0.025
Swollen joint count (Week 24)	0.018
Morning stiffness (Week 12)	0.019
Morning stiffness (Week 24)	-0.05
Degree of pain (Week 12)	0.022
Degree of pain (Week 24)	0.012
Sleepiness (Week 12)	0.002
Sleepiness (Week 24)	0.059
Depression (Week 12)	-0.02
Depression (Week 24)	-0.016

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in haemoglobin levels versus change in swollen joint count (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.257
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in haemoglobin levels versus change in swollen joint count (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.487
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in morning stiffness (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.644
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in morning stiffness (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.498
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in degree of pain (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.650
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in degree of pain (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.750
	Comments
	Method	Regression, Cox
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in sleepiness (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.936
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in sleepiness (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.075
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in depression score (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.098
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in depression score (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.090
	Comments
	Method	Regression, Linear
	Comments

8. Secondary Outcome

Title	Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population
Description	Regression analysis between the change in hemoglobin level and number of swollen joints was evaluated. Hemoglobin level was measure in g/L. The regression coefficient (R) and coefficient of determination (R^2) were calculated. Difference (1-R^2) indicates the variation in the changes in hemoglobin not explained by the independent variables, that is, independent contribution of these changes in hemoglobin to the assessment of RA. Only variables with available data were reported.
Time Frame	Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety analysis population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	98
Week 12 (n=91)	0.186
Week 24 (n=98)	0.005

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in swollen joint count (Week 12)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.077
	Comments
	Method	Multiple Regression
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	change in hemoglobin levels versus change in swollen joint count (Week 24)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.961
	Comments
	Method	Multiple Regression
	Comments

9. Secondary Outcome

Title	Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24
Description	Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, Week 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. N=participants who were evaluable for this outcome measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	83
Baseline for Week 12	5.9 (4.6)
Change at Week 12	1.9 (3.5)
Baseline for Week 24	6.0 (4.6)
Change at Week 24	1.8 (3.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

10. Secondary Outcome

Title	Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population
Description	Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	113
Baseline for Week 12 (n=109)	5.7 (4.2)
Change at Week 12 (n=109)	2.1 (4.1)
Baseline for Week 24 (n=113)	5.9 (4.3)
Change at Week 24 (n=113)	1.8 (3.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

11. Secondary Outcome

Title	Change From Baseline in Duration of Morning Stiffness at Week 12, 24
Description	Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. N=participants who were evaluable for this outcome measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	83
Baseline for Week 12	1.4 (2.7)
Change at Week 12	0.5 (0.9)
Baseline for Week 24	1.4 (2.8)
Change at Week 24	0.4 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

12. Secondary Outcome

Title	Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population
Description	Duration of morning stiffness assessed as time taken to achieve maximum improvement from time participant rises. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	112
Baseline for Week 12 (n=109)	1.4 (2.5)
Change at Week 12 (n=109)	0.5 (0.8)
Baseline for Week 24 (n=112)	1.4 (2.5)
Change at Week 24 (n=112)	0.4 (0.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

13. Secondary Outcome

Title	Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24
Description	Change from Baseline in 10 centimeter (cm) VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. N=participants who were evaluable for this outcome measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	83
Baseline for Week 12	6.8 (2.1)
Change at Week 12	2.57 (2.52)
Baseline for Week 24	6.8 (2.1)
Change at Week 24	2.57 (2.95)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

14. Secondary Outcome

Title	Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population
Description	Change from Baseline in 10 cm VAS pain score; 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. Change = scores at observation minus score at Baseline. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	112
Baseline for Week 12 (n=107)	6.9 (2.0)
Change at Week 12 (n=107)	2.59 (2.5)
Baseline for Week 24 (n=112)	6.9 (2.1)
Change at Week 24 (n=112)	2.69 (2.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

15. Secondary Outcome

Title	Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24
Description	Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	83
Baseline for Week 12 (n=82)	6.0 (4.6)
Change at Week 12 (n=82)	5.4 (5.0)
Baseline for Week 24 (n=83)	6.1 (4.6)
Change at Week 24 (n=83)	5.3 (4.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.172
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Regression, Logistic
	Comments

16. Secondary Outcome

Title	Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population
Description	Degree of sleepiness was assessed by Epworth Sleepiness Scale. The Epworth Sleepiness Scale evaluates how likely a person is to doze off or fall asleep in 8 different sedentary situations, using for each item possible scores of 0 to 3 (0=never, 1=mild, 2=moderate and 3=severe). A final score is obtained between 0-24, where a higher score indicates a higher degree of sleepiness. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	113
Baseline for Week 12 (n=109)	6.4 (5.0)
Change at Week 12 (n=109)	6.0 (4.4)
Baseline for Week 24 (n=113)	6.4 (4.5)
Change at Week 24 (n=113)	5.4 (4.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.162
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

17. Secondary Outcome

Title	Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24
Description	Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. N=participants who were evaluable for this outcome measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	84
Baseline for Week 12	17.4 (11.7)
Change at Week 12	3.07 (9.09)
Change at Week 24	3.5 (8.99)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.005
	Comments
	Method	t-test, 2 sided
	Comments

18. Secondary Outcome

Title	Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population
Description	Mood assessed by the Beck Depression Inventory. The Beck Depression Inventory is a 21-item self-administered scale that evaluates severity of depression and is validated in Spanish on a 3 point scale (0=none to 3=severe). It measures the characteristic attitudes and symptoms of depression such as mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, etc. The total score ranges from 0 to 63. A score higher than 18 indicates moderate to severe symptoms of depression. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety population. N=participants who were evaluable for this outcome measure. n=number of participants evaluable in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	113
Baseline for Week 12 (n=111)	18.3 (12.6)
Change at Week 12 (n=111)	3.5 (9.4)
Baseline for Week 24 (n=113)	18.5 (12.7)
Change at Week 24 (n=113)	3.89 (11.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.005
	Comments
	Method	t-test, 2 sided
	Comments

19. Secondary Outcome

Title	Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24
Description	DAS28-4 erythrocyte sedimentation rate (ESR) was calculated from SJC and tender joint count (TJC) using 28 joints count, ESR millimeter per hour (mm/hr) and patient global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>)3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) less than (<)2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Baseline data is reported separately for Weeks 12 and 24 to include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis: All participants who had at least one measurement of effectiveness subsequent to the start of tocilizumab (RoActemra) treatment were included. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	71
Baseline for Week 12 (n=66)	3.0 (1.2)
Change at Week 12 (n=66)	2.53 (1.2)
Baseline for Week 24 (n=71)	2.7 (1.3)
Change at Week 24 (n=71)	2.73 (1.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 12 versus Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Rheumatoid Arthritis Participants
	Comments	Baseline for Week 24 versus Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

20. Secondary Outcome

Title	Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population
Description	DAS28-4 ESR was calculated from SJC and TJC using 28 joints count, ESR mm/hr and PtGA of disease activity (participant rated arthritis activity assessment). The DAS28-ESR score (14) was calculated using the following formula: DAS28 = 0.56 x (square root TJC) + 0.28 x (square root SJC) + 0.70 x [Ln(ESR)] + 0.014 x (PtGA).Total score range: 0-9.4, higher score=more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-4 (ESR) <2.6 = remission. PtGA measured using a 100 mm VAS ranging from 0 = very good to 100 = very bad. Analysis include only those participants who had available data at Weeks 12 and 24, respectively.
Time Frame	Baseline, Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety population. N=participants who were evaluable for this outcome measure.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	115
Baseline for Week 12	5.6 (1.0)
Change at Week 12	2.5 (1.1)
Change at Week 24	2.7 (1.4)

21. Secondary Outcome

Title	Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24
Description	Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.
Time Frame	Week 12, 24

Outcome Measure Data

Analysis Population Description

Effectiveness analysis population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	71
Good response at Week 12 (n=66)	56.1 46.8%
Good response at Week 24 (n=71)	62.0 51.7%
Moderate or good response at Week 12 (n=66)	95.5 79.6%
Moderate or good response at Week 24 (n=71)	93.0 77.5%

22. Secondary Outcome

Title	Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population
Description	Response was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from Baseline. Participants with a score <=3.2 and reduction of >1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score <=5.1 with reduction of >0.6 to <=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to <=1.2 points, or any score with reduction ≤0.6 points, were assessed as nonresponders with response recorded as 'none.' Participants with response is reported. DAS28 is described in outcome measure 19.
Time Frame	Week 12, 24

Outcome Measure Data

Analysis Population Description

Safety population. N=participants who were evaluable for this outcome measure. n=number of evaluable participants in each category.

Arm/Group Title	Rheumatoid Arthritis Participants
Arm/Group Description	Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
Measure Participants	115
Good response at Week 12 (n=85)	51 42.5%
Good response at Week 24 (n=92)	61 50.8%
Moderate or good response at Week 12 (n=85)	95.3 79.4%
Moderate or good response at Week 24 (n=92)	94.6 78.8%

Adverse Events

Time Frame	Up to 1.5 year
Adverse Event Reporting Description	Safety analysis population: All participants who received at least one dose of the tocilizumab.
Arm/Group Title	All Participants
Arm/Group Description	Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	3/120 (2.5%)
Infections and infestations
Arthritis infective	1/120 (0.8%)
Pilonidal cyst	1/120 (0.8%)
Acute endocarditis	1/120 (0.8%)
Respiratory tract infection	1/120 (0.8%)
Renal and urinary disorders
Pyelonephritis acute	1/120 (0.8%)
Respiratory, thoracic and mediastinal disorders
Respiratory failure	1/120 (0.8%)
Rheumatoid lungs	1/120 (0.8%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	27/120 (22.5%)
Gastrointestinal disorders
Aphthous stomatitis	7/120 (5.8%)
Infections and infestations
Viral infection	6/120 (5%)
Metabolism and nutrition disorders
Hypercholesterolemia	16/120 (13.3%)
Vascular disorders
Hypertension	7/120 (5.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.