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A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tocilizumab 162 mg
Placebo
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients, ≥ years of age.
  • Moderate to severe rheumatoid arthritis of ≥ 6 months duration.
  • Receiving treatment on an outpatient basis.
  • Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count) at screening and study start.
  • On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start.

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.
  • Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's Syndrome with rheumatoid arthritis is allowed.
  • Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis.
  • Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years.
  • Prior history of or current inflammatory joint disease other than rheumatoid arthritis.
  • History of malignancy, active or recurrent infections, positive to hepatitis B surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations.

Other inclusion and exclusion criteria applied to the study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tocilizumab 162 mg sc

Placebo sc

Arm Description

Patients will receive tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.

Patients will receive placebo subcutaneously (sc) every 2 weeks for 24 weeks.

Outcomes

Primary Outcome Measures

Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24
A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).

Secondary Outcome Measures

Percentage of Patients With ACR50 and ACR70 Responses at Week 24
A patient had an ACR50 response if there was at least a 50% improvement in the ACR scores. A patient had an ACR70 response if there was at least a 70% improvement in the ACR scores.
Time to Onset of ACR20, ACR50, and ACR70 Responses
Time to first ACR response was calculated as the number of days between the date of the first ACR response minus the date of the first dose of study drug. Median days are reported.
Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24
Joints (28 joints) will be assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination.
Change From Baseline in C-reactive Protein at Week 24
Change From Baseline in Erythrocyte Sedimentation Rate at Week 24
Change From Baseline in the Patient's and the Physician's Global Assessment of Disease Activity Visual Analog (VAS) Score
Patients and physicians assessed the patient's disease activity in the previous 24 hours on a 100 mm visual analog scale, where the extreme left end of the line represented "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end represented "maximum disease activity". Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.
Change From Baseline in the Patient's Pain Visual Analog Score
Patients assessed their pain in the previous 24 hours on a visual analog scale, where the extreme left end of the line represented "no pain" and the extreme right end represented "unbearable pain". Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.
Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.
Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.
Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24
The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24
The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.
Change From Baseline in Hemoglobin at Week 24

Full Information

First Posted
November 1, 2010
Last Updated
July 7, 2015
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01232569
Brief Title
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official Title
A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (RoActemra/Actemra) in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs) in patients with active, moderate to severe rheumatoid arthritis. In the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an auto-injector.

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
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
656 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tocilizumab 162 mg sc
Arm Type
Experimental
Arm Description
Patients will receive tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
Arm Title
Placebo sc
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo subcutaneously (sc) every 2 weeks for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Tocilizumab 162 mg
Other Intervention Name(s)
RoActemra, Actemra
Intervention Description
Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
Primary Outcome Measure Information:
Title
Percentage of Patients With an American College of Rheumatology 20 (ACR20) Response at Week 24
Description
A patient had an ACR20 response if there was at least a 20% improvement, ie, reduction from baseline, in tender and swollen joint counts (28 assessed joints) and in at least 3 of the following 5 parameters: Separate patient and physician assessments of patient disease activity in the previous 24 hours on a visual analog scale (VAS, left end=no disease activity [symptom-free and no arthritis symptoms], right end=maximum disease activity; patient assessment of pain in previous 24 hours on a VAS (left end=no pain and right end=unbearable pain); Health Assessment Questionnaire-Disability Index (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do); and acute-phase reactant (either C-reactive protein or erythrocyte sedimentation rate).
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Percentage of Patients With ACR50 and ACR70 Responses at Week 24
Description
A patient had an ACR50 response if there was at least a 50% improvement in the ACR scores. A patient had an ACR70 response if there was at least a 70% improvement in the ACR scores.
Time Frame
Baseline to Week 24
Title
Time to Onset of ACR20, ACR50, and ACR70 Responses
Description
Time to first ACR response was calculated as the number of days between the date of the first ACR response minus the date of the first dose of study drug. Median days are reported.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Week 24
Description
Joints (28 joints) will be assessed and classified as swollen/not swollen and tender/not tender by pressure and joint manipulation on physical examination.
Time Frame
Baseline to Week 24
Title
Change From Baseline in C-reactive Protein at Week 24
Time Frame
Baseline to Week 24
Title
Change From Baseline in Erythrocyte Sedimentation Rate at Week 24
Time Frame
Baseline to Week 24
Title
Change From Baseline in the Patient's and the Physician's Global Assessment of Disease Activity Visual Analog (VAS) Score
Description
Patients and physicians assessed the patient's disease activity in the previous 24 hours on a 100 mm visual analog scale, where the extreme left end of the line represented "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end represented "maximum disease activity". Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.
Time Frame
Baseline to Week 24
Title
Change From Baseline in the Patient's Pain Visual Analog Score
Description
Patients assessed their pain in the previous 24 hours on a visual analog scale, where the extreme left end of the line represented "no pain" and the extreme right end represented "unbearable pain". Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.
Time Frame
Baseline to Week 24
Title
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Description
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
Time Frame
Baseline to Week 24
Title
Percentage of Patients With an Improvement of ≥ 0.3 Units From Baseline in the HAQ-DI Score at Week 24
Description
The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Patients completed the questionnaire by answering the 20 questions on a scale of 0 (without difficulty) to 3 (unable to do). The total score ranges from 0 (no disability) to 3 (completely disabled). A negative change score indicates improvement.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Disease Activity Score 28 (DAS28) at Week 24
Description
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.
Time Frame
Baseline to Week 24
Title
Percentage of Patients With a DAS28 Score ≤ 3.2 (DAS28 Low Disease Activity) at Week 24
Description
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.
Time Frame
Baseline to Week 24
Title
Percentage of Patients With a DAS28 Score < 2.6 (DAS28 Remission) at Week 24
Description
The DAS28 is a combined index for measuring disease activity in rheumatic arthritis (RA) and includes swollen and tender joint counts, erythrocyte sedimentation rate (ESR), and general health (GH) status. The index is calculated with the following formula: DAS28 = (0.56 × √(TJC28)) + (0.28 × √(SJC28)) + (0.7 × log(ESR)) + (0.014 × GH), where TJC28 = tender joint count and SJC28 = swollen joint count, each on 28 joints. GH = a patient's global assessment of disease activity in the previous 24 hours on a 100 mm visual analog scale (left end = no disease activity [symptom-free and no arthritis symptoms], right end = maximum disease activity [maximum arthritis disease activity]). When ESR equaled 0 mm/hr, it was set to 1 mm/hr. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A negative change score indicates improvement.
Time Frame
Week 24
Title
Percentage of Patients With Good, Moderate, or no European League Against Rheumatism (EULAR) Responses at Week 24
Description
Change of the Disease Activity Score 28 score from baseline was used to determine EULAR responses of good, moderate, or no response. For a post-baseline score ≤ 3.2, a change from baseline of < -1.2 was a good response, < -0.6 to ≥ -1.2 was a moderate response, and ≥ -0.6 was no response. For a post-baseline score > 3.2 to ≤ 5.1, a change from baseline of < -0.6 was a moderate response and ≥ -0.6 was no response. For a post-baseline score > 5.1, a change from baseline < -1.2 was a moderate response and ≥ -1.2 was no response. A good response could not be achieved for post-baseline scores > 3.2.
Time Frame
Baseline to Week 24
Title
Change From Baseline in the Van Der Heijde Modified Sharp Radiographic Score at Week 24
Description
The degree of joint damage was assessed using the van der Heijde modified total Sharp score (mTSS). The methodology quantifies the extent of bone erosions for 44 joints and joint space narrowing (JSN) for 42 joints, with higher scores representing greater damage. The independent read of X-ray images was performed by 2 primary readers. In case of discrepancy between the 2 primary readers, an adjudicator was involved. The mTSS can range from 0 to 448 with a higher score indicating more joint damage. A negative change score indicates improvement.
Time Frame
Baseline to Week 24
Title
Change From Baseline in the Physical and Mental Component Scores of the Short Form 36 (SF-36) Health Survey at Week 24
Description
The SF-36 Health Survey uses patient-reported symptoms on 8 subscales to assess health-related quality of life (HRQoL). The Physical Component Summary (PCS) score summarizes the subscales Physical Functioning, Role-Physical, Bodily Pain, and General Health. The Mental Component Summary (MCS) score summarizes the subscales Vitality, Social Functioning, Role-Emotional, and Mental Health. Each score was scaled from 0 to 100 with a higher score indicating better HRQoL. A positive change score indicates an improvement in HRQoL.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Hemoglobin at Week 24
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, ≥ years of age. Moderate to severe rheumatoid arthritis of ≥ 6 months duration. Receiving treatment on an outpatient basis. Swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC)≥ 8 (68 joint count) at screening and study start. On a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start. Exclusion Criteria: Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization. Rheumatic autoimmune disease other than rheumatoid arthritis, Secondary Sjögren's Syndrome with rheumatoid arthritis is allowed. Functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in Rheumatoid Arthritis. Diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years. Prior history of or current inflammatory joint disease other than rheumatoid arthritis. History of malignancy, active or recurrent infections, positive to hepatitis B surface antigen or hepatitis C antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic GI conditions that might predispose to perforations. Other inclusion and exclusion criteria applied to the 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:
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34292
Country
United States
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Meridan
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
City
Vernon Hills
State/Province
Illinois
ZIP/Postal Code
60061
Country
United States
City
Crofton
State/Province
Maryland
ZIP/Postal Code
21114
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77459
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
City
Cairns
ZIP/Postal Code
4870
Country
Australia
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
City
Curitiba
ZIP/Postal Code
80060-240
Country
Brazil
City
Goiania
ZIP/Postal Code
74043-011
Country
Brazil
City
Juiz de Fora
ZIP/Postal Code
36010-570
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
City
Salvador
ZIP/Postal Code
40050-410
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
05437-010
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
5403900
Country
Brazil
City
São Paulo
ZIP/Postal Code
04026-000
Country
Brazil
City
São Paulo
ZIP/Postal Code
1244030
Country
Brazil
City
Vitoria
ZIP/Postal Code
29055-450
Country
Brazil
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
City
Sofia
ZIP/Postal Code
2233
Country
Bulgaria
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
City
Pointe-claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
Country
Canada
City
Bogota
Country
Colombia
City
Chia-cundinamarca
Country
Colombia
City
Medellin
Country
Colombia
City
Athens
ZIP/Postal Code
11527
Country
Greece
City
Athens
ZIP/Postal Code
15121
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
City
Guatemala City
ZIP/Postal Code
01013
Country
Guatemala
City
Guatemala City
ZIP/Postal Code
01015
Country
Guatemala
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
City
Haifa
ZIP/Postal Code
31048
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
City
Rishon Lezion
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
City
Kota Kinabalu
ZIP/Postal Code
88586
Country
Malaysia
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
City
Culiacan
ZIP/Postal Code
80000
Country
Mexico
City
Guadalajara
ZIP/Postal Code
44158
Country
Mexico
City
Leon
ZIP/Postal Code
37320
Country
Mexico
City
Merida
ZIP/Postal Code
97000
Country
Mexico
City
Mexicali
ZIP/Postal Code
21100
Country
Mexico
City
Mexico
ZIP/Postal Code
44620
Country
Mexico
City
Morelia
ZIP/Postal Code
58070
Country
Mexico
City
Obregon
ZIP/Postal Code
85000
Country
Mexico
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
City
Queretaro
ZIP/Postal Code
76178
Country
Mexico
City
Otahuhu
ZIP/Postal Code
1006
Country
New Zealand
City
Panama City
ZIP/Postal Code
32400
Country
Panama
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
City
Davao
ZIP/Postal Code
8006
Country
Philippines
City
Manila
ZIP/Postal Code
1780
Country
Philippines
City
Bytom
ZIP/Postal Code
41902
Country
Poland
City
Dzialdowo
ZIP/Postal Code
13-200
Country
Poland
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
City
Koscian
ZIP/Postal Code
64-000
Country
Poland
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
City
Torun
ZIP/Postal Code
87-100
Country
Poland
City
Warszawa
ZIP/Postal Code
02-653
Country
Poland
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129327
Country
Russian Federation
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
City
Saint-petersburg
ZIP/Postal Code
197341
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
City
Durban
ZIP/Postal Code
4013
Country
South Africa
City
Pinelands
ZIP/Postal Code
7405
Country
South Africa
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
24942540
Citation
Kivitz A, Olech E, Borofsky M, Zazueta BM, Navarro-Sarabia F, Radominski SC, Merrill JT, Rowell L, Nasmyth-Miller C, Bao M, Wright S, Pope JE. Subcutaneous tocilizumab versus placebo in combination with disease-modifying antirheumatic drugs in patients with rheumatoid arthritis. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1653-61. doi: 10.1002/acr.22384.
Results Reference
derived

Learn more about this trial

A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis

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