Back to resultsA Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
tocilizumab [RoActemra/Actemra]
tocilizumab [RoActemra/Actemra]
Nonbiologic DMARDs of investigator's choice
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- moderate to severe active rheumatoid arthritis for >6 months;
- inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
- Swollen joint count (SJC) >/=4 and Tender joint count (TJC) >/=4
- body weight </=150kg
- current permitted non-biologic DMARDs must be on stable dose for >/= 7 weeks prior to baseline;
Exclusion Criteria:
- history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
- treatment with rituximab within 6 months before screening;
- intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
- known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Tocilizumab 8 mg/kg Monotherapy
Tocilizumab 4 mg/kg + DMARD
Tocilizumab 8 mg/kg + DMARD
Arm Description
Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Outcomes
Primary Outcome Measures
Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period
An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Secondary Outcome Measures
Percentage of Participants Experiencing Serious Adverse Events of Special Interest
Serious Adverse Events of Special interest include:
Serious infections including opportunistic infections
Complications of diverticulitis (including lower gastrointestinal [GI] perforations)
Myocardial infarction/acute coronary syndrome
Stroke
Spontaneous or serious bleeding
Malignant neoplasms
Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest
Non-serious adverse Events of Special interest include:
Serious/Medically Significant Hepatic Events
Spontaneous /Serious Bleeding
Malignant Neoplasms
Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24
Clinical Remission is defined as a Disease Activity Score 28 [DAS28] < 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Change From Baseline in DAS28 Score at Weeks 8, 16 and 24
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of > 5.1 represents high disease activity.
The Change from Baseline to Weeks 8, 16 and 24 is reported.
Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24
The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:
Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and
At least 3 of the following 5 assessments:
Patient's global assessment of pain-Visual Analog Scale (VAS)
Patient global assessment of disease activity-(VAS)
Physician global assessment of disease activity-(VAS)
Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)
Acute phase response C-Reactive Protein (CRP)
Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8
Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.
Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20
Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient's benefit-risk after Week 12.
Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24
The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.
Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24
The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00891020
Brief Title
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Official Title
Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
March 2011 (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 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership with the FDA to manage known and potential risks associated with the treatment of tocilizumab. Patients will be randomized to receive tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is 500-1000 individuals.
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
None (Open Label)
Allocation
Randomized
Enrollment
886 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab 8 mg/kg Monotherapy
Arm Type
Experimental
Arm Description
Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Arm Title
Tocilizumab 4 mg/kg + DMARD
Arm Type
Experimental
Arm Description
Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Arm Title
Tocilizumab 8 mg/kg + DMARD
Arm Type
Experimental
Arm Description
Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion.
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
8 mg/kg intravenous every 4 weeks for 24 weeks
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
4 mg/kg every 4 weeks for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Nonbiologic DMARDs of investigator's choice
Intervention Description
Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed
Primary Outcome Measure Information:
Title
Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period
Description
An SAE was any adverse event that at any dose fulfilled at least one of the following criteria:
Was fatal (results in death)
Was life-threatening
Required in-patient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant disability/incapacity
Was a congenital anomaly/birth defect
Was medically significant or required intervention to prevent one or other of the outcomes listed above.
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants Experiencing Serious Adverse Events of Special Interest
Description
Serious Adverse Events of Special interest include:
Serious infections including opportunistic infections
Complications of diverticulitis (including lower gastrointestinal [GI] perforations)
Myocardial infarction/acute coronary syndrome
Stroke
Spontaneous or serious bleeding
Malignant neoplasms
Time Frame
24 Weeks
Title
Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest
Description
Non-serious adverse Events of Special interest include:
Serious/Medically Significant Hepatic Events
Spontaneous /Serious Bleeding
Malignant Neoplasms
Time Frame
24 Weeks
Title
Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24
Description
Clinical Remission is defined as a Disease Activity Score 28 [DAS28] < 2.6. The DAS28 is a combined index for measuring disease activity in RA. The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Time Frame
Weeks 8,16,24
Title
Change From Baseline in DAS28 Score at Weeks 8, 16 and 24
Description
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes tender joint count (TJC) -28 joints and swollen joint count (SJC)-28 joints, acute phase response C-reactive protein (CRP) and general health status. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. A score of < 2.6 represents clinical remission, a score of ≤ 3.2 represents low disease activity, and a score of > 5.1 represents high disease activity.
The Change from Baseline to Weeks 8, 16 and 24 is reported.
Time Frame
Baseline, Weeks 8,16,24
Title
Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24
Description
The ACR response rates ACR20, ACR50, and ACR70 are defined as ≥20%, ≥50%, and ≥70% improvement from baseline, respectively, in:
Swollen Joint Count (66 joints) and Tender Joint Count (68 joints) and
At least 3 of the following 5 assessments:
Patient's global assessment of pain-Visual Analog Scale (VAS)
Patient global assessment of disease activity-(VAS)
Physician global assessment of disease activity-(VAS)
Patient assessment of disability (physical function scale of the Multidimensional Health Assessment Questionnaire)
Acute phase response C-Reactive Protein (CRP)
Time Frame
Baseline, Weeks 8,16,24
Title
Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8
Description
Dosage could be increased from 4 mg/kg Tocilizumab to 8 mg/kg due to failure to achieve 20% improvement from baseline in swollen and tender joint counts.
Time Frame
Baseline, Week 8
Title
Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20
Description
Dosage of Tocilizumab 4 mg/kg could be increased to 8 mg/kg at the discretion of the investigator based on assessment of the patient's benefit-risk after Week 12.
Time Frame
Weeks 12,16, 20
Title
Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24
Description
The RAPID3 is a combined index derived from the Multidimensional Health Assessment Questionnaire that includes physical function score, pain Visual Analog Scale (VAS), and global assessment of disease activity VAS. The total RAPID3 score ranges from 0 to 10 where higher scores represent worse outcomes. A negative change from baseline indicates improvement.
Time Frame
Baseline, Weeks 8,16,24
Title
Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24
Description
The fatigue VAS is a single-item, patient-reported outcome that measures the severity of the fatigue over the past week. Patients rate their fatigue on a scale of 0 (fatigue is no problem) to 100 (fatigue is a major problem). Higher scores represent higher disease activity and a negative change from baseline indicates improvement.
Time Frame
Baseline, Weeks 8,16,24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >=18 years of age;
moderate to severe active rheumatoid arthritis for >6 months;
inadequate clinical response or unable to tolerate current or prior biologic or non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;
Swollen joint count (SJC) >/=4 and Tender joint count (TJC) >/=4
body weight </=150kg
current permitted non-biologic DMARDs must be on stable dose for >/= 7 weeks prior to baseline;
Exclusion Criteria:
history of autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
functional class IV as defined by the American College of Rheumatology (ACR) Classification of Functional Status in rheumatoid arthritis;
treatment with rituximab within 6 months before screening;
intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv) corticosteroids within 12 weeks prior to screening;
known active current or history of recurrent infections, or any major episode of infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of screening, or oral antibiotics within 2 weeks prior to screening.
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
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
City
Hot Springs
State/Province
Arizona
ZIP/Postal Code
71913
Country
United States
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
27203
Country
United States
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72903
Country
United States
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
City
Murrieta
State/Province
California
ZIP/Postal Code
92563
Country
United States
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
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
Santa Barbara
State/Province
California
ZIP/Postal Code
93108
Country
United States
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91423
Country
United States
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
City
Victorville
State/Province
California
ZIP/Postal Code
92295
Country
United States
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
City
Whittier
State/Province
California
ZIP/Postal Code
90606
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Dunedin
State/Province
Florida
ZIP/Postal Code
34698
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
30501
Country
United States
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Lake Mary
State/Province
Florida
ZIP/Postal Code
32746
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33618
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60195
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
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52401
Country
United States
City
Lees Summit
State/Province
Kansas
ZIP/Postal Code
64086
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40515
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
City
Ellicott City
State/Province
Maryland
ZIP/Postal Code
21042
Country
United States
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
City
Pascagoula
State/Province
Massachusetts
ZIP/Postal Code
39581
Country
United States
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
City
Plymouth
State/Province
Massachusetts
ZIP/Postal Code
02360
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01610
Country
United States
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49015
Country
United States
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
City
St Clair Shores
State/Province
Michigan
ZIP/Postal Code
48080
Country
United States
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38802
Country
United States
City
Florissant
State/Province
Missouri
ZIP/Postal Code
63031
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63117
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
63110
Country
United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07012
Country
United States
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
City
Manalapan
State/Province
New Jersey
ZIP/Postal Code
07726
Country
United States
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
City
Trenton
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
City
Cooperstown
State/Province
New York
ZIP/Postal Code
13326
Country
United States
City
Hewlett
State/Province
New York
ZIP/Postal Code
11557
Country
United States
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
City
Olean
State/Province
New York
ZIP/Postal Code
14760
Country
United States
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
City
Utica
State/Province
New York
ZIP/Postal Code
13504
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
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
28210
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Rock Hill
State/Province
North Carolina
ZIP/Postal Code
29732
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44333
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45402
Country
United States
City
Gallipolis
State/Province
Ohio
ZIP/Postal Code
45631
Country
United States
City
Mayfield
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Perryburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Lebanon
State/Province
Pennsylvania
ZIP/Postal Code
17042
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
City
Pottstown
State/Province
Pennsylvania
ZIP/Postal Code
19464
Country
United States
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
City
Hickory
State/Province
South Carolina
ZIP/Postal Code
28602
Country
United States
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
City
Hendersonville
State/Province
Tennessee
ZIP/Postal Code
37073
Country
United States
City
Hixson
State/Province
Tennessee
ZIP/Postal Code
37343
Country
United States
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37027
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231-4406
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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
77074
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
City
Nassau Bay
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
City
Waco
State/Province
Texas
ZIP/Postal Code
76708
Country
United States
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
City
Brookfield
State/Province
Wisconsin
ZIP/Postal Code
53045
Country
United States
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
City
Onalaska
State/Province
Wisconsin
ZIP/Postal Code
54605
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22972745
Citation
Weinblatt ME, Kremer J, Cush J, Rigby W, Teng LL, Devenport J, Singh N, Lepley D, Genovese MC. Tocilizumab as monotherapy or in combination with nonbiologic disease-modifying antirheumatic drugs: twenty-four-week results of an open-label, clinical practice study. Arthritis Care Res (Hoboken). 2013 Mar;65(3):362-71. doi: 10.1002/acr.21847.
Results Reference
derived
Learn more about this trial
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
We'll reach out to this number within 24 hrs