Back to resultsAn Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tocilizumab [RoActemra/Actemra]
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- male and non-pregnant or nursing female patients >=18 years of age;
- body weight <=150kg;
- moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;
- on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;
- inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
- if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
Exclusion Criteria:
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
- rheumatic autoimmune disease other than RA;
- prior history of, or current inflammatory joint disease other than RA;
- functional class IV as defined by the ACR Classification of Functional Status in RA.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Adverse Events (AEs): Overall Summary
Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.
Secondary Outcome Measures
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (≤)3.2 and remission was defined as DAS28 less than (<)2.6.
Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 ≤3.2 and remission was defined as DAS28 <2.6.
Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event
The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 ≤3.2 and remission defined as DAS28 <2.6.
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. If the EULAR response could not be determined, it was set to 'No response'.
DAS28 Scores by Visit
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale [VAS]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.
Swollen Joint Count by Visit
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A negative change from baseline indicates improvement.
Tender Joint Count by Visit
Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A negative change from baseline indicates improvement.
Patient's Global Assessment of Disease Activity by Visit
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as "maximum disease activity" (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Physician's Global Assessment of Disease Activity by Visit
The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as "maximum disease activity" (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Patient's Global Assessment of Pain by Visit
The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as "no pain" and the right-hand extreme=100 mm as "unbearable pain". The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
C-Reactive Protein by Visit
The test for CRP (mg per deciliter [mg/dL]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Erythrocyte Sedimentation Rate by Visit
ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.
HAQ-DI Scores by Visit
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful.
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of <0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of ≥0.22.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
FACIT-Fatigue is a 13-item questionnaire; participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00750880
Brief Title
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
Official Title
International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 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 open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion 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 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
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1681 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
8mg/kg iv (60 minute infusion)
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs): Overall Summary
Description
Percentage of participants with AEs, serious AEs (SAEs), related AEs, related SAEs, severe AEs, with AEs leading to withdrawal or dose modification, with infection, serious infection, infusion reactions, infusion reactions during an infusion, infusion reactions within 24 hours of an infusion, major adverse cardiac event (MACE), or death.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Low Disease Activity or Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) by Visit
Description
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 less than or equal to (≤)3.2 and remission was defined as DAS28 less than (<)2.6.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Time to Low Disease Activity or Remission Based on DAS28 - Number of Participants With an Event
Description
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity was defined as DAS28 ≤3.2 and remission was defined as DAS28 <2.6.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Time to Low Disease Activity and Remission Based on DAS28 Score - Time to Event
Description
The time to low disease activity or remission was calculated as the number of days from study Day 1 to the first occurrence of low disease activity or remission. Participants who did not achieve low disease activity on or before Week 24 or who withdrew from the study prior to achieving low disease activity were considered censored. DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Low disease activity defined as DAS28 ≤3.2 and remission defined as DAS28 <2.6.
Time Frame
Baseline,Weeks 4, 8, 12, 16, 20, and 24
Title
Percentage of Participants Achieving a Response by European League Against Rheumatism (EULAR) Response Category and Visit
Description
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline >1.2 with DAS28 ≤3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to =<1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1. If the EULAR response could not be determined, it was set to 'No response'.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
DAS28 Scores by Visit
Description
DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. A negative change from baseline indicates improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%), 50%, 70%, or 90% Improvement (ACR20/ACR50/ACR70/ACR90) by Visit
Description
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (visual analog scale [VAS]); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the Health Assessment Questionnaire Disability Index (HAQ-DI); or acute phase reactant (ESR or C-reactive protein [CRP]). Participants who did not have the required data to assess ACR status at a given visit were classified as non-responders.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response - Number of Participants With an Event
Description
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP).
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Time to Achieve ACR20, ACR50, ACR70 and ACR90 Response
Description
ACR20, ACR50, ACR70, and ACR90 are defined as ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in: swollen joint count (SJC; 66 joints) and tender joint count (TJC; 68 joints) and ≥20%, ≥50%, ≥70%, or ≥90% improvement, respectively, in 3 of following 5 assessments: Patient's Global Assessment of Pain (VAS); Patient's Global Assessment of Disease Activity (VAS); Investigator/Physician's Global Assessment of Disease Activity (VAS); participant's assessment of disability measured by the HAQ-DI; or acute phase reactant (ESR or CRP). Time to ACR response was calculated as the number of days from day 1 of study to the date of first achievement of ACR response. Data represent median time for responders only.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Swollen Joint Count by Visit
Description
Number of swollen joints was determined by examination of 66 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 66. A negative change from baseline indicates improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Tender Joint Count by Visit
Description
Number of tender joints was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 68. A negative change from baseline indicates improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Patient's Global Assessment of Disease Activity by Visit
Description
The participant's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line=0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm, as "maximum disease activity" (maximum arthritis disease activity). The line was marked by the participant and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Physician's Global Assessment of Disease Activity by Visit
Description
The physician's global assessment of disease activity is assessed on a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line=0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme=100 mm as "maximum disease activity" (maximum arthritis disease activity). The physician marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Patient's Global Assessment of Pain by Visit
Description
The participants assessed their pain using a 0 to 100 mm horizontal VAS. The left-hand extreme of the line=0 mm, and is described as "no pain" and the right-hand extreme=100 mm as "unbearable pain". The participant marked the line and the distance from the left edge was recorded. A negative change from baseline indicated improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
C-Reactive Protein by Visit
Description
The test for CRP (mg per deciliter [mg/dL]) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Erythrocyte Sedimentation Rate by Visit
Description
ESR (mm/hr) is a blood test used to monitor therapy in inflammatory diseases such as rheumatoid arthritis (RA) and reflects acute phase reactant levels. Active disease in RA is defined by an ESR greater than 30 mm/hr. Change from baseline is computed as the value at each week minus the baseline value. A negative value in change from baseline indicates an improvement.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
HAQ-DI Scores by Visit
Description
HAQ-DI includes 20 questions concerning participant's activities of daily life, grouped in 8 scales of 2 to 3 questions for each activity. To respond to each question, a four-level response (score of 0 to 3 points), with higher scores showing larger functional limitations, was chosen. Scoring was as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1=with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. Minimum score was 0, maximum score was 3.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Short Form-36 (SF-36) Physical Functioning Domain Scores by Visit
Description
The SF-36 covers 8 health dimensions including 4 physical subscales (physical function, role-physical, bodily pain, and general health) and 4 mental subscales (vitality, social function, role-emotional, and mental health). The scores range from a minimum of 0 to a maximum of 100, with a higher score indicating better quality of life. Improvements of >3 points were considered clinically meaningful.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Percentage of Participants With HAQ-DI Clinical Remission and Clinically Meaningful Improvement By Visit
Description
The HAQ-DI scale ranges from 0 to 3, where higher scores represent higher disease activity. A score of <0.5 represents clinical remission. A participant achieves a clinically meaningful improvement in HAQ-DI if they had a reduction from baseline of ≥0.22.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score by Visit
Description
FACIT-Fatigue is a 13-item questionnaire; participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status.
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male and non-pregnant or nursing female patients >=18 years of age;
body weight <=150kg;
moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;
on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;
inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.
Exclusion Criteria:
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
rheumatic autoimmune disease other than RA;
prior history of, or current inflammatory joint disease other than RA;
functional class IV as defined by the ACR Classification of Functional Status in RA.
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
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2601
Country
Australia
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
City
Parramatta Park
State/Province
New South Wales
ZIP/Postal Code
4870
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Graz-Eggenberg
ZIP/Postal Code
8020
Country
Austria
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
City
Stockerau
ZIP/Postal Code
2000
Country
Austria
City
Wien
ZIP/Postal Code
1100
Country
Austria
City
Wien
ZIP/Postal Code
1130
Country
Austria
City
Wien
ZIP/Postal Code
1160
Country
Austria
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
City
Gent
ZIP/Postal Code
9000
Country
Belgium
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
City
Heusy
ZIP/Postal Code
4802
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
City
Montignies S/ Sambre
ZIP/Postal Code
6061
Country
Belgium
City
Westmalle
ZIP/Postal Code
2390
Country
Belgium
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
City
Lethbridge
State/Province
Alberta
ZIP/Postal Code
T1J 0N9
Country
Canada
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
City
Nanaimo
State/Province
British Columbia
ZIP/Postal Code
V9S 4S1
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3Y1
Country
Canada
City
Quispamsis
State/Province
New Brunswick
ZIP/Postal Code
E2E 4J8
Country
Canada
City
St John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1C 5B8
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4K 1N2
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7G 2E6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 8W1
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
City
St-eustache
State/Province
Quebec
ZIP/Postal Code
J7P 4J2
Country
Canada
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
City
Bruntal
ZIP/Postal Code
792 01
Country
Czech Republic
City
Ostrava
ZIP/Postal Code
722 00
Country
Czech Republic
City
Praha
ZIP/Postal Code
128 50
Country
Czech Republic
City
Sokolov
ZIP/Postal Code
356 01
Country
Czech Republic
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czech Republic
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
City
Hjørring
ZIP/Postal Code
9800
Country
Denmark
City
København
ZIP/Postal Code
2100
Country
Denmark
City
København
ZIP/Postal Code
2400
Country
Denmark
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
City
Århus
ZIP/Postal Code
8000
Country
Denmark
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
City
Jyvaeskylae
ZIP/Postal Code
40100
Country
Finland
City
Turku
ZIP/Postal Code
20521
Country
Finland
City
Argenteuil
ZIP/Postal Code
95107
Country
France
City
Aulnay Sous Bois
ZIP/Postal Code
93602
Country
France
City
Belfort
ZIP/Postal Code
90016
Country
France
City
Bobigny
ZIP/Postal Code
93009
Country
France
City
Bourg En Bresse
ZIP/Postal Code
01012
Country
France
City
Caen
ZIP/Postal Code
14033
Country
France
City
Cahors
ZIP/Postal Code
46005
Country
France
City
Colmar
ZIP/Postal Code
68024
Country
France
City
Corbeil-essonnes
ZIP/Postal Code
91106
Country
France
City
Dijon
ZIP/Postal Code
21000
Country
France
City
La Rochelle
ZIP/Postal Code
17019
Country
France
City
Lievin
ZIP/Postal Code
62806
Country
France
City
Lomme
ZIP/Postal Code
59462
Country
France
City
Lyon
ZIP/Postal Code
69365
Country
France
City
Lyon
ZIP/Postal Code
69437
Country
France
City
Marseille
ZIP/Postal Code
13385
Country
France
City
Montivilliers
ZIP/Postal Code
76290
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Mulhouse
ZIP/Postal Code
68070
Country
France
City
Paris
ZIP/Postal Code
75475
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Pau
ZIP/Postal Code
64046
Country
France
City
Poitiers
ZIP/Postal Code
86021
Country
France
City
Reims
ZIP/Postal Code
51092
Country
France
City
Roubaix
ZIP/Postal Code
59056
Country
France
City
St Brieuc
ZIP/Postal Code
22027
Country
France
City
Strasbourg
ZIP/Postal Code
67098
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Valence
ZIP/Postal Code
26000
Country
France
City
Valenciennes
ZIP/Postal Code
59322
Country
France
City
Berlin
ZIP/Postal Code
13125
Country
Germany
City
Bielefeld
ZIP/Postal Code
33611
Country
Germany
City
Freiburg
ZIP/Postal Code
79098
Country
Germany
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
City
Jena
ZIP/Postal Code
07747
Country
Germany
City
Kiel
ZIP/Postal Code
24116
Country
Germany
City
Rostock
ZIP/Postal Code
18059
Country
Germany
City
Saarbruecken
ZIP/Postal Code
66111
Country
Germany
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
City
Wuppertal
ZIP/Postal Code
42105
Country
Germany
City
Athens
ZIP/Postal Code
115 27
Country
Greece
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
City
Patras
ZIP/Postal Code
265 04
Country
Greece
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
City
Thessaloniki
Country
Greece
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
City
Eger
ZIP/Postal Code
3300
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Szeged
ZIP/Postal Code
6724
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Bangalore
ZIP/Postal Code
560003
Country
India
City
Chennai
ZIP/Postal Code
600 020
Country
India
City
Hyderabad
ZIP/Postal Code
500004
Country
India
City
Jaipur
ZIP/Postal Code
302 015
Country
India
City
Kolkata
ZIP/Postal Code
700 020
Country
India
City
Kolkata
ZIP/Postal Code
700 072
Country
India
City
Ludhiana
ZIP/Postal Code
141001
Country
India
City
Mumbai
ZIP/Postal Code
400007
Country
India
City
New Delhi
ZIP/Postal Code
110076
Country
India
City
Pune
ZIP/Postal Code
411001
Country
India
City
Co Leitrim
Country
Ireland
City
Cork
Country
Ireland
City
Dublin
ZIP/Postal Code
15
Country
Ireland
City
Dublin
ZIP/Postal Code
4
Country
Ireland
City
Dublin
ZIP/Postal Code
7
Country
Ireland
City
Dublin
ZIP/Postal Code
9
Country
Ireland
City
Galway
Country
Ireland
City
Limerick
ZIP/Postal Code
0
Country
Ireland
City
Waterford
Country
Ireland
City
Arenzano
ZIP/Postal Code
16011
Country
Italy
City
Legnano
ZIP/Postal Code
20025
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Monserrato
ZIP/Postal Code
09042
Country
Italy
City
Novara
ZIP/Postal Code
28100
Country
Italy
City
Palermo
ZIP/Postal Code
90127
Country
Italy
City
Pescara
ZIP/Postal Code
65100
Country
Italy
City
Potenza
ZIP/Postal Code
85100
Country
Italy
City
Roma
ZIP/Postal Code
00144
Country
Italy
City
Roma
ZIP/Postal Code
00152
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Luxembourg
ZIP/Postal Code
2763
Country
Luxembourg
City
'S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
City
Amsterdam
ZIP/Postal Code
1056 AB
Country
Netherlands
City
Apeldoorn
ZIP/Postal Code
7300 DS
Country
Netherlands
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
City
Bergen Op Zoom
ZIP/Postal Code
4624 VT
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2545 CH
Country
Netherlands
City
Den Haag
ZIP/Postal Code
2597 AX
Country
Netherlands
City
Den Helder
ZIP/Postal Code
1782GZ
Country
Netherlands
City
Enschede
ZIP/Postal Code
7511 JX
Country
Netherlands
City
Gorinchem
ZIP/Postal Code
4204 AA
Country
Netherlands
City
Gouda
ZIP/Postal Code
2803 HH
Country
Netherlands
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
City
Hilversum
ZIP/Postal Code
1213 HX
Country
Netherlands
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
City
Leidschendam
ZIP/Postal Code
2262 BA
Country
Netherlands
City
Nieuwegein
ZIP/Postal Code
3430 EM
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6522 JV
Country
Netherlands
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
City
Schiedam
ZIP/Postal Code
3116 BA
Country
Netherlands
City
Spijkenisse
ZIP/Postal Code
3201 GZ
Country
Netherlands
City
Vlissingen
ZIP/Postal Code
4382 EE
Country
Netherlands
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
City
Poznan
ZIP/Postal Code
61-545
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
City
Bucharest
ZIP/Postal Code
011172
Country
Romania
City
Bucharest
ZIP/Postal Code
020475
Country
Romania
City
Cluj-napoca
ZIP/Postal Code
400006
Country
Romania
City
Jeddah
ZIP/Postal Code
21423
Country
Saudi Arabia
City
Jeddah
ZIP/Postal Code
21461
Country
Saudi Arabia
City
Jeddah
ZIP/Postal Code
21499
Country
Saudi Arabia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
City
Elda
State/Province
Alicante
ZIP/Postal Code
03600
Country
Spain
City
Aviles
State/Province
Avila
ZIP/Postal Code
33400
Country
Spain
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
City
VIC
State/Province
Barcelona
ZIP/Postal Code
08500
Country
Spain
City
Cádiz
State/Province
Cadiz
ZIP/Postal Code
11009
Country
Spain
City
Jerez de La Frontera
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
City
La Coruna
State/Province
La Coruña
ZIP/Postal Code
15006
Country
Spain
City
Las Palmas De Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35020
Country
Spain
City
Ponferrada
State/Province
Leon
ZIP/Postal Code
24411
Country
Spain
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Almeria
ZIP/Postal Code
04009
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
City
Caceres
ZIP/Postal Code
10310
Country
Spain
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
City
Granada
ZIP/Postal Code
18014
Country
Spain
City
Huesca
ZIP/Postal Code
22004
Country
Spain
City
Leon
ZIP/Postal Code
24071
Country
Spain
City
Lugo
ZIP/Postal Code
27004
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28905
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Murcia
ZIP/Postal Code
30120
Country
Spain
City
Orense
ZIP/Postal Code
32005
Country
Spain
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Tenerife
ZIP/Postal Code
38010
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Valencia
ZIP/Postal Code
46017
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Falun
ZIP/Postal Code
79182
Country
Sweden
City
Huddinge
ZIP/Postal Code
SE-141 86
Country
Sweden
City
Karlstad
ZIP/Postal Code
65185
Country
Sweden
City
Linkoeping
ZIP/Postal Code
58185
Country
Sweden
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
City
Skoevde
ZIP/Postal Code
54185
Country
Sweden
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
City
Västerås
ZIP/Postal Code
72189
Country
Sweden
City
Aarau
ZIP/Postal Code
5000
Country
Switzerland
City
Basel
ZIP/Postal Code
4055
Country
Switzerland
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
City
Barnsley
ZIP/Postal Code
S75 2EP
Country
United Kingdom
City
Basingstoke
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
City
Bournemouth
ZIP/Postal Code
BH23 2JX
Country
United Kingdom
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
City
Burton on Trent
ZIP/Postal Code
DE13 0RB
Country
United Kingdom
City
Bury St Edmonds
ZIP/Postal Code
IP33 2QZ
Country
United Kingdom
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
City
Dudley
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
City
Dundee
ZIP/Postal Code
DD12 9SY
Country
United Kingdom
City
Eastbourne
ZIP/Postal Code
BN21 2UD
Country
United Kingdom
City
Gillingham
ZIP/Postal Code
ME7 5NY
Country
United Kingdom
City
Harrogate
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
City
Ipswich
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
City
Llantrisant
ZIP/Postal Code
CF72 8XR
Country
United Kingdom
City
Londonderry
ZIP/Postal Code
BT47 6SB
Country
United Kingdom
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
City
Reading
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
City
Southport
ZIP/Postal Code
PR8 6PN
Country
United Kingdom
City
Swindon
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
City
Westcliffe-on-sea
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
City
Worthing
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.
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