An Global Comparative Observational Study of RoActemra/Ac... | NCT01543503

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24	Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker [erythrocyte sedimentation rate (ESR) in millimeter/hour (mm/h), or C-reactive protein (CRP) in milligram/liter (mg/L)]. For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of less than or equal to (</=) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.	Baseline and Week 24

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52	Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.

Eligibility Module

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28622454	Derived	Choy EH, Bernasconi C, Aassi M, Molina JF, Epis OM. Treatment of Rheumatoid Arthritis With Anti-Tumor Necrosis Factor or Tocilizumab Therapy as First Biologic Agent in a Global Comparative Observational Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1484-1494. doi: 10.1002/acr.23303. Epub 2017 Sep 6.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
BG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-2.795(-3.107 to -2.483) OG001-1.945(-2.249 to -1.640)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Treatment Difference between Tocilizumab and TNF inhibitor: Analysis is based on an analysis of covariance (ANCOVA) model with change from baseline in DAS28-ESR at 24 weeks as dependent variable; therapy, site country, and treatment as fixed effects; DAS28-ESR at baseline as covariates.	ANCOVA		<0.001		Mean Difference (Net)	-0.851			2-Sided	95	-1.112	-0.589				No	Superiority or Other

Secondary

Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52

Disease activity score based on 28 joint counts (DAS28) is a composite measure of disease severity and it incorporates four specific measures of disease: swollen joint count (SJC) of 28 joints, tender joint count (TJC) of 28 joints, Patient's Global Assessment of Disease Activity by visual analogue scale (VAS), and acute-phase inflammatory marker (ESR in mm/h, or CRP in mg/L). For the purposes of this study, ESR was used whenever possible to calculate the DAS28 (DAS28-ESR). Higher the scores, greater is the disease activity. A DAS28 score of </= 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.

The effectiveness analysis population was used for analysis. Data of participants available at the time of the assessment were included in the analysis.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline and Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001

Secondary

Mean Change From Baseline in Erythrocyte Sedimentation Rate

Blood samples were collected for ESR, which is an acute phase reactant and a measure of inflammation. BL = baseline.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.

Posted

Least Squares Mean

95% Confidence Interval

mm/hr

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Mean Change From Baseline in C-reactive Protein

Blood samples were collected for C-reactive protein (CRP). CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point

Posted

Least Squares Mean

95% Confidence Interval

mg/L

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Mean Change From Baseline in Swollen Joint Count

A swollen joint count (SJC) is the most specific clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. Twenty-eight joints were assessed for swelling. Joints were classified as swollen (1)/ not swollen (0) giving a total possible SJC score of 0 to 28.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.

Posted

Least Squares Mean

95% Confidence Interval

Number of swollen joints

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Mean Change From Baseline in Tender Joint Count

A tender joint count (TJC) is the most specific clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. Twenty-eight joints were assessed for tenderness. Joints were classified as tender (1)/not tender (0) giving a total possible TJC score of 0 to 28.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.

Posted

Least Squares Mean

95% Confidence Interval

Number of tender joints

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score

Clinical Disease Activity Index (CDAI) was calculated as the sum of the following parameters: SJC + TJC + VAS Patient Global Assessment of Disease Activity + VAS Physician Global Assessment of Disease Activity. VAS assessments involved a 10-cm horizontal scale from 'no disease activity' to 'maximum disease activity'. CDAI scores ranged from 0 to 76, with higher scores indicating increased disease activity. Simplified Disease Activity Index (SDAI) was calculated as the sum of the following parameters: SJC +TJC + Patient Global Assessment of Disease Activity + Physician Global Assessment of Disease Activity + CRP. SDAI scores ranged from 0 to 86, with higher scores also indicating increased disease activity.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Mean Change From Baseline in Physician Global Assessment Score

The Physician's Global Assessment of disease activity was assessed using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). Change from baseline = scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.

Posted

Least Squares Mean

95% Confidence Interval

scores on a scale

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor

Secondary

Loss of Efficacy or Development of Intolerance to Biologic Therapy

Events that are clearly consistent with the expected pattern of progression of the underlying disease may contribute to lack of efficacy. Lack of efficacy was one of the reasons for termination of biology therapy. The number of participants showing lack of efficacy to biologic therapy is presented.

The safety population included all recruited participants who received at least one dose of a TNF inhibitor or tocilizumab during the study.

Posted

Number

participants

Up to Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Proportion of Participants Who Terminated Biologic Treatment

The proportion of participants who discontinued biologic treatment was compared between tocilizumab-treated and TNF inhibitor-treated participants.

The safety population was used for analysis.

Posted

Number

Percentage of participants

Up to Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Reasons for Treatment Discontinuation

The reasons for discontinuation of tocilizumab or TNF inhibitor is presented.

The safety population was used for analysis.

Posted

Number

participants

Up to Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period

The total number of participants who discontinued biologic therapy at the end of each study period (Week 0 - 24, Week 24 - 52, Week 52 - 57 and Week 57 - end of treatment) is presented. Participants who did not have a biologic therapy discontinuation or discontinued before having one, were considered as 'censored' at the date study termination.

The safety population was used for analysis.

Posted

Number

participants

Up to end of treatment

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy

An infusion reaction was defined as an adverse event (AE) occurring during and within 24 hours after the infusion, which may include hypersensitivity reactions or anaphylactic reactions. Injection site reactions were included in the summaries for infusion reactions.

The safety population was used for analysis.

Posted

Number

participants

Up to Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events

An AE is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable 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 any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.

The safety population was used for analysis.

Posted

Number

participants

Up to Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study

Adverse events of special interest (AESI) for this study included: infections (including opportunistic infections), myocardial infarction/acute coronary syndrome, gastrointestinal perforation and related events, malignancies, anaphylaxis / hypersensitivity reactions, demyelinating disorders, stroke, bleeding events and hepatic events. Based on seriousness criteria, they were categorized as serious and non-serious adverse events of special interest.

The safety population was used for analysis.

Posted

Number

participants

Up to Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score

The Health Assessment Questionnaire-Disability Index (HAQ-DI) is a 20-question instrument that assesses the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping and activities of daily living). Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). HAQ-DI total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; more than 1=significant functional limitation.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.

Posted

Least Squares Mean

95% Confidence Interval

Scores on a scale

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor

Secondary

Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score

Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-F score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.

Posted

Least Squares Mean

95% Confidence Interval

scores on a scale

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Mean Change From Baseline in Visual Analogue Scale Pain Score

VAS is a 100 mm scale. Intensity of pain range: 0 mm=no pain to 100 mm=worst possible pain. Change from baseline =scores at observation minus score at baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point.

Posted

Least Squares Mean

95% Confidence Interval

units on a scale

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Shift From Baseline in Morning Stiffness

Shift tables presenting the number of participants in each bivariate category Week (W) 0 versus Week 24 and Week 52, with regards to morning stiffness at the different time points, was presented for each treatment arm. For participants who experienced joint stiffness while waking up in the morning, duration of morning stiffness was categorized as follows: Less than 30 minutes (min), Between 30 and 60 minutes, Between 60 and 120 minutes, Between 120 to 240 minutes, More than 240 minutes and the whole day. Baseline = BL

The effectiveness analysis population was used for analysis.

Posted

Number

participants

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Secondary

Change From Baseline in Patient Global Assessment of Disease Activity

The patient's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.

The effectiveness analysis population was used for analysis. n = the number of participants available for assessment at a given time point

Posted

Least Squares Mean

95% Confidence Interval

scores on a scale

Baseline, Week 24, Week 52

ID	Title	Description
OG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
OG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tocilizumab	Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.			22	423	132	423
EG001	TNF Inhibitor	Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.			64	793	231	793

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0012 affected793 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Angina unstable	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Pericardial effusion	Cardiac disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Parophthalmia	Eye disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0012 affected793 at risk
Chest pain	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0013 affected793 at risk
Injection site rash	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Malaise	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Multi-organ failure	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Oedema peripheral	General disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Ulcer	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Hypersensitivity	Immune system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0012 affected793 at risk
Abscess	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Abscess of salivary gland	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Arthritis bacterial	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Bacterial sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Cellulitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Cytomegalovirus gastritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Epididymitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Erysipelas	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0012 affected793 at risk
Graft infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Infected skin ulcer	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Intervertebral discitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0016 affected793 at risk
Osteomyelitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Peritonitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Pharyngitis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0012 affected793 at risk
Pneumonia	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 affected423 at risk EG0016 affected793 at risk
Pyelonephritis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Sepsis	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0013 affected793 at risk
Staphylococcal infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0012 affected793 at risk
Wound infection	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0011 affected793 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Transaminases increased	Investigations	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0013 affected793 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0012 affected793 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0013 affected793 at risk
Demyelination	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 18.1	Systematic Assessment	EG0002 affected423 at risk EG0011 affected793 at risk
Depression	Psychiatric disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0010 affected793 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0011 affected793 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.1	Systematic Assessment	EG0000 affected423 at risk EG0012 affected793 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 18.1	Systematic Assessment	EG00014 affected423 at risk EG0013 affected793 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0004 affected423 at risk EG0019 affected793 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 18.1	Systematic Assessment	EG0009 affected423 at risk EG00115 affected793 at risk
INJECTION SITE REACTION	General disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG00122 affected793 at risk
BRONCHITIS	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00011 affected423 at risk EG00113 affected793 at risk
CELLULITIS	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0002 affected423 at risk EG0018 affected793 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0004 affected423 at risk EG0018 affected793 at risk
LOWER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00015 affected423 at risk EG00135 affected793 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00013 affected423 at risk EG00118 affected793 at risk
PHARYNGITIS	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0005 affected423 at risk EG0014 affected793 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0005 affected423 at risk EG00110 affected793 at risk
SINUSITIS	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG0006 affected423 at risk EG0018 affected793 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 18.1	Systematic Assessment	EG00015 affected423 at risk EG00126 affected793 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 18.1	Systematic Assessment	EG0008 affected423 at risk EG00113 affected793 at risk
NEUTROPHIL COUNT DECREASED	Investigations	MedDRA 18.1	Systematic Assessment	EG0005 affected423 at risk EG0018 affected793 at risk
TRANSAMINASES INCREASED	Investigations	MedDRA 18.1	Systematic Assessment	EG00010 affected423 at risk EG0014 affected793 at risk
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG0009 affected423 at risk EG0015 affected793 at risk
HYPERTRIGLYCERIDAEMIA	Metabolism and nutrition disorders	MedDRA 18.1	Systematic Assessment	EG00010 affected423 at risk EG0017 affected793 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 18.1	Systematic Assessment	EG0004 affected423 at risk EG00111 affected793 at risk
HEADACHE	Nervous system disorders	MedDRA 18.1	Systematic Assessment	EG0007 affected423 at risk EG00123 affected793 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG00010 affected423 at risk EG00112 affected793 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 18.1	Systematic Assessment	EG0003 affected423 at risk EG0019 affected793 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0004 affected423 at risk EG0018 affected793 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0001 affected423 at risk EG0018 affected793 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 18.1	Systematic Assessment	EG0009 affected423 at risk EG00123 affected793 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Catamarca Capital		4700	Argentina

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases