Back to resultsA Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Participants who completed their last WA19926 (NCT01649804) core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
- No current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit
- Women of childbearing potential must agree to use highly reliable contraception during the treatment period
Exclusion Criteria:
- Pregnant or breastfeeding females
- Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
- Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
- Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926 (NCT01649804)
- Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
- Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than RA
- Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint disease other than RA
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
- Evidence of severe uncontrolled concomitant disease or disorder
- Known active infections or history of recurrent infections
- Active tuberculosis requiring treatment in the previous 3 years
- History of alcohol, drug or chemical abuse since inclusion in the WA19926 (NCT01649804) study
Sites / Locations
- CIP - Centro Internacional de Pesquisa
- Centro Mineiro de Pesquisa - CMIP
- Centro de Estudos em Terapias Inovadoras - CETI
- Hospital Sao Lucas - PUCRS
- Universidade Federal de Sao Paulo - UNIFESP; Reumatologia
- Centro Paulista de Investigacao Clinica - CEPIC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tocilizumab
Arm Description
Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) every 4 weeks for up to 104 weeks.
Outcomes
Primary Outcome Measures
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator.
Percentage of Participants With TEAEs of Special Interest
An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. Nine categories of AE of special interest are identified for tocilizumab which includes a) serious/medically significant infections, b) myocardial infarction/acute coronary syndrome, c) gastrointestinal perforations, d) malignancies, e) anaphylaxis/hypersensitivity reactions, f) demyelinating disorders, g) stroke, h) serious and/or medically significant bleeding events, and i) serious/medically significant hepatic events. Data reported is an average of the nine categories.
Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation
An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started.
Secondary Outcome Measures
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
The DAS28-ESR is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) (patient global assessment of disease activity [PGA] using visual analog scale [VAS], range 1-100 millimeters [mm]) (higher scores indicate higher disease activity). DAS28-ESR is calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm [ln] ESR in mm/h) + (0.014*GH in mm VAS). DAS28-ESR scale is transformed and ranges from 0 to 10. A negative CFB indicated improvement.
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
The SDAI is a combined index for measuring disease activity. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), physician global assessment (PhGA) and PGA of disease activity, both scored 0 to 10 centimeters (cm) as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal is less than (<) 1 mg/dL. SDAI is calculated according to the following formula: SDAI = TJC + SJC + PhGA + PGA + CRP. SDAI ranges from 0 to 86. A negative CFB indicated improvement.
CFB in Swollen Joint Count (SJC) at Specified Time Points
For SJC, a total of 66 joints are assessed. The presence of a swollen joint is scored as 1 and absence as 0. Total score is calculated by adding the scores, which ranges from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicated no swollen joint and higher scores indicated worsening swollen joints.
CFB in Tender Joint Count (TJC) at Specified Time Points
The number of tender joints is recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued
Remission: DAS28-ESR score <2.6 and SDAI score </=3.3. DAS28-ESR index included SJC and TJC, both scored 0-28, as well as APR determined as ESR in mm/hr, and GH (ranges 1-100 mm; higher scores=higher disease activity). DAS28=(0.56*√TJC)+(0.28*√SJC) +(0.70*ln ESR) +(0.014*GH). DAS28-ESR scale is transformed and ranges from 0 to 10. Negative CFB indicated improvement. DAS28 >2.6 (clinical remission); DAS28 2.6 to 3.2 (low disease activity); DAS28 >3.2 to 5.1 = moderate to high disease activity. SDAI is sum of TJC and SJC (both scored 0-28), PhGA and PGA of disease activity (both scored 0 to 10 cm as assessed by VAS, higher scores=higher disease activity), and CRP in mg/dL where normal is <1 mg/dL. SDAI=TJC + SJC + PhGA + PGA + CRP. SDAI ranged from 0 to 86. A negative CFB indicated improvement. SDAI <=3.3 (clinical remission), >3.4 to 11 (low disease activity) >11 to 26 (moderate disease activity), and >26 = (high/severe disease activity).
Time to RA Crisis Among Participants Who Discontinued After Clinical Remission
RA crisis is any worsening of participant disease acitivity that, in the opinion of the investigator, required intensified treatment other than supportive therapy, and may have included restart of the treatment with the study drug. Time to RA crisis is defined as the period of remission without drug until the RA crisis documentation.
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
PGA 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 CFB indicated improvement.
CFB in PGA of Pain Using VAS Score at Specified Time Points
PGA of pain is assessed on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm, and is described as "unbearable pain". A negative change indicated improvement.
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
PhGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. 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).
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
HAQ-DI is a self-reported participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Total score for HAQ-DI is the sum of all questions and ranges from 0 = without any difficulty to 60 = unable to do. A negative CFB indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01668966
Brief Title
A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
Official Title
A Multicenter, Open-Label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 9, 2013 (Actual)
Primary Completion Date
May 11, 2016 (Actual)
Study Completion Date
May 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab
Arm Type
Experimental
Arm Description
Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) every 4 weeks for up to 104 weeks.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
RoActemra, Actemra
Intervention Description
Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
An adverse event (AE) is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. An SAE can be a) fatal, b) life-threatening, c) requires/prolongs hospitalization, d) results in persistent/significant incapacity/disability, e) results in congenital anomaly/birth defect or f) is considered as a significant medical event by the investigator.
Time Frame
Baseline up to approximately 104 weeks
Title
Percentage of Participants With TEAEs of Special Interest
Description
An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started. Nine categories of AE of special interest are identified for tocilizumab which includes a) serious/medically significant infections, b) myocardial infarction/acute coronary syndrome, c) gastrointestinal perforations, d) malignancies, e) anaphylaxis/hypersensitivity reactions, f) demyelinating disorders, g) stroke, h) serious and/or medically significant bleeding events, and i) serious/medically significant hepatic events. Data reported is an average of the nine categories.
Time Frame
Baseline up to approximately 104 weeks
Title
Percentage of Participants With TEAEs Leading to Change in Dose or Study Drug Discontinuation
Description
An AE is any unfavorable or unintended sign (including an abnormal laboratory finding), symptom or disease temporarily associated with use of study drug, regardless of its relation to study drug. A TEAE is an AE that occurs only once treatment has started.
Time Frame
Baseline up to approximately 104 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline (CFB) in Disease Activity Score 28 Using Erythrocyte Sedimentation Rate (DAS28-ESR) at Specified Time Points
Description
The DAS28-ESR is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) (patient global assessment of disease activity [PGA] using visual analog scale [VAS], range 1-100 millimeters [mm]) (higher scores indicate higher disease activity). DAS28-ESR is calculated according to the following formula: DAS28-ESR equals (=) [0.56 multiplied by (*) the square root (√) of TJC] plus (+) [0.28 * √ of SJC] + (0.70 * the natural logarithm [ln] ESR in mm/h) + (0.014*GH in mm VAS). DAS28-ESR scale is transformed and ranges from 0 to 10. A negative CFB indicated improvement.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
Title
CFB in Simplified Disease Activity Index (SDAI) Score at Specified Time Points
Description
The SDAI is a combined index for measuring disease activity. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), physician global assessment (PhGA) and PGA of disease activity, both scored 0 to 10 centimeters (cm) as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal is less than (<) 1 mg/dL. SDAI is calculated according to the following formula: SDAI = TJC + SJC + PhGA + PGA + CRP. SDAI ranges from 0 to 86. A negative CFB indicated improvement.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
Title
CFB in Swollen Joint Count (SJC) at Specified Time Points
Description
For SJC, a total of 66 joints are assessed. The presence of a swollen joint is scored as 1 and absence as 0. Total score is calculated by adding the scores, which ranges from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicated no swollen joint and higher scores indicated worsening swollen joints.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
Title
CFB in Tender Joint Count (TJC) at Specified Time Points
Description
The number of tender joints is recorded on the joint assessment form, no tenderness = 0, tenderness = 1, for 68 joints and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
Title
Percentage of Participants Reaching Clinical Remission (DAS28-ESR Score Less Than [<] 2.6 and/or SDAI Score Less Than or Equal to [</=] 3.3) Among Participants for Whom Tocilizumab Treatment Was Discontinued
Description
Remission: DAS28-ESR score <2.6 and SDAI score </=3.3. DAS28-ESR index included SJC and TJC, both scored 0-28, as well as APR determined as ESR in mm/hr, and GH (ranges 1-100 mm; higher scores=higher disease activity). DAS28=(0.56*√TJC)+(0.28*√SJC) +(0.70*ln ESR) +(0.014*GH). DAS28-ESR scale is transformed and ranges from 0 to 10. Negative CFB indicated improvement. DAS28 >2.6 (clinical remission); DAS28 2.6 to 3.2 (low disease activity); DAS28 >3.2 to 5.1 = moderate to high disease activity. SDAI is sum of TJC and SJC (both scored 0-28), PhGA and PGA of disease activity (both scored 0 to 10 cm as assessed by VAS, higher scores=higher disease activity), and CRP in mg/dL where normal is <1 mg/dL. SDAI=TJC + SJC + PhGA + PGA + CRP. SDAI ranged from 0 to 86. A negative CFB indicated improvement. SDAI <=3.3 (clinical remission), >3.4 to 11 (low disease activity) >11 to 26 (moderate disease activity), and >26 = (high/severe disease activity).
Time Frame
Baseline up to approximately 104 weeks
Title
Time to RA Crisis Among Participants Who Discontinued After Clinical Remission
Description
RA crisis is any worsening of participant disease acitivity that, in the opinion of the investigator, required intensified treatment other than supportive therapy, and may have included restart of the treatment with the study drug. Time to RA crisis is defined as the period of remission without drug until the RA crisis documentation.
Time Frame
Baseline up to approximately 104 weeks
Title
CFB in PGA of Disease Activity Using VAS Score at Specified Time Points
Description
PGA 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 CFB indicated improvement.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
Title
CFB in PGA of Pain Using VAS Score at Specified Time Points
Description
PGA of pain is assessed on a 0 to 100 mm horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm, and is described as "unbearable pain". A negative change indicated improvement.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
Title
CFB in PhGA of Disease Activity Using VAS Score at Specified Time Points
Description
PhGA of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. 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).
Time Frame
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
Title
CFB in Health Assessment Questionnaire-Disease Index (HAQ-DI) Score at Specified Time Points
Description
HAQ-DI is a self-reported participant questionnaire specific for RA. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip; common daily activities. Each domain has at least 2 component questions. There are 4 possible responses for each component 0=without any difficulty 1=with some difficulty 2=with much difficulty 3=unable to do. Total score for HAQ-DI is the sum of all questions and ranges from 0 = without any difficulty to 60 = unable to do. A negative CFB indicates improvement.
Time Frame
Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, early withdrawal (up to 104 weeks), follow-up 1 (8 weeks after the last visit or discontinuation; 112 weeks), follow-up 2 (16 weeks after the last visit or discontinuation; 120 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who completed their last WA19926 (NCT01649804) core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
No current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit
Women of childbearing potential must agree to use highly reliable contraception during the treatment period
Exclusion Criteria:
Pregnant or breastfeeding females
Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926 (NCT01649804)
Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than RA
Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint disease other than RA
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
Evidence of severe uncontrolled concomitant disease or disorder
Known active infections or history of recurrent infections
Active tuberculosis requiring treatment in the previous 3 years
History of alcohol, drug or chemical abuse since inclusion in the WA19926 (NCT01649804) study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
CIP - Centro Internacional de Pesquisa
City
Goiania
State/Province
GO
ZIP/Postal Code
74110-120
Country
Brazil
Facility Name
Centro Mineiro de Pesquisa - CMIP
City
Juiz de Fora
State/Province
MG
ZIP/Postal Code
36036-330
Country
Brazil
Facility Name
Centro de Estudos em Terapias Inovadoras - CETI
City
Curtiba
State/Province
PR
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo - UNIFESP; Reumatologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04026-000
Country
Brazil
Facility Name
Centro Paulista de Investigacao Clinica - CEPIC
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04266-010
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)
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