Back to resultsA Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- adult patients, >=18 years of age;
- rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria;
- DAS28 of >3.2;
- At screening either ESR >=28 mm/h or CRP >=1 mg/dL;
- Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
Exclusion Criteria:
- major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening;
- functional class IV as identified by the ACR classification of functional status in RA;
- rheumatoid autoimmune disease other than RA;
- prior history of or current inflammatory joint disease other than RA.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tocilizumab
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Low Disease Activity Score at Week 24
Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Secondary Outcome Measures
Absolute Changes in DAS28 From Baseline
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant rated global assessment of disease activity using 100-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category
The 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.
Percentage of Participants With a DAS28 Response at Weeks 4 and 24
DAS28 calculated from the number of swollen joints and painful joints using the 28-joint count, the ESR and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment using VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 = low disease activity, DAS28 <2.6 = remission and a clinically significant (CS) reduction was defined as ≥1.2.
Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response
ACR20/50/70 response: ≥20%, 50%, or 70% improvement, respectively, in swollen and tender joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).
Change From Baseline in Swollen and Tender Joint Counts at Week 24
Swollen joint count: 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.
Tender joint counts: 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
Change From Baseline in the Levels of C-Reactive Protein at Week 24
The serum concentration of CRP is measured in mg/L. A reduction in the level was considered an improvement.
Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24
Participant's global assessment of pain was assessed using a 100-mm horizontal VAS (0 to 100 mm) with 0=pain absent and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their current level of pain.
Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24
Participant's global assessment of disease activity was an overall assessment of their current disease activity on a 100-mm horizontal VAS scale (left-hand extreme: "no disease activity"; right-hand extreme: "maximum disease activity").
Physician's global assessment of disease activity was measured as participant's current disease activity on a 100-mm horizontal VAS scale (left hand extreme: "no disease activity"; right-hand extreme: "maximum disease activity").
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
CDAI was calculated according to the following formula:
CDAI = Number of swollen joints (plus) + Number of tender joints + VAS disease activity participant assessment + VAS disease activity investigator assessment. The maximum score was 334 (66 joints + 68 joints + 100 mm + 100 mm); higher scores indicated higher disease activity.
Change From Baseline in HAQ-DI at Week 24
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). 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.
Change From Baseline in Short Form-36 (SF-36) Score at Week 24
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Absolute change was defined as the change from baseline to Week 24.
Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)
Participant's were asked to state the worst level of pain felt in the past 24 hours using a 100-mm horizontal VAS (0 to 100 mm) with 0=no pain and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their level of pain. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.
Duration of Morning Stiffness as Assessed Using PTHF
Duration of morning stiffness: participants were asked 'how long did your morning stiffness last from the time you woke up yesterday' and the response was provided in minutes and hours. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.
Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF
Participants were asked to assess their overall level of fatigue/tiredness during the previous 24 hours using a 100-mm horizontal VAS with 0=none and 100=very severe. Participants responded by placing a mark on the line to indicate their current level of fatigue. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.
Treatment Satisfaction Questionnaire for Medication (TSQM) Score
The TSQM is a general measure of participants treatment satisfaction and consists of 14 questions that result in 4 subscales: "effectiveness", "side-effects", "convenience" and "global satisfaction". All subscale scores range from 0 to 100%, with 100% being the best possible result.
Changes in Hemoglobin
Hemoglobin levels were determined as a hematology parameter to measure changes in disease related anemia.
Changes in C-Reactive Protein
CRP is an acute phase inflammatory marker used as a measure of inflammation. A reduction in CRP is considered to be an improvement.
Changes in Erythrocyte Sedimentation Rate (ESR)
ESR is an inflammation marker used to determine acute phase response.
Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response
Participants who withdrew from study drug due to other reasons were not taken into account.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00754559
Brief Title
A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.
Official Title
"Effectiveness After Four and Twentyfour Weeks and Safety of Tocilizumab in Patients With Active RA"
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (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 single arm study will assess the effectiveness of tocilizumab in combination with traditional DMARDs with regard to the clinical improvement in disease activity (achievement of LDAS) after 24 weeks' treatment in patients with active rheumatoid arthritis (RA) who have had an inadequate response to current traditional DMARD and/or anti-TNF therapy. Patients will receive tocilizumab 8mg/kg iv every 4 weeks, in addition to ongoing DMARDs at the stable pre-entry dose prescribed by the physician, for a total of 6 infusions during the regular treatment period and a further 6 infusions during an optional extension phase. The anticipated time on study treatment is 6 to 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
N/A
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
8mg/kg iv every 4 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Low Disease Activity Score at Week 24
Description
Low Disease Activity Score (LDAS) is defined as Disease Activity score less than or equal to (≤ ) 3.2. Disease activity score 28 (DAS28) was calculated from the number of swollen joints and tender joints using the 28-joint count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and global health assessment (participant rated global assessment of disease activity using 100-mm Visual analog scale [VAS]); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Absolute Changes in DAS28 From Baseline
Description
DAS28 calculated from the number of swollen joints and tender joints using the 28-joint count, the ESR (mm/hour) and global health assessment (participant rated global assessment of disease activity using 100-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. DAS28 ≤3.2 = low disease activity, DAS28 greater than (>)3.2 to 5.1 = moderate to high disease activity.
Time Frame
Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Title
Percentage of Participants With a Response at Week 24 by European League Against Rheumatism (EULAR) Category
Description
The 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.
Time Frame
Week 24
Title
Percentage of Participants With a DAS28 Response at Weeks 4 and 24
Description
DAS28 calculated from the number of swollen joints and painful joints using the 28-joint count, the ESR and participant's global assessment (PGA) of disease activity (participant rated arthritis activity assessment using VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 = low disease activity, DAS28 <2.6 = remission and a clinically significant (CS) reduction was defined as ≥1.2.
Time Frame
Weeks 4 and 24
Title
Percentage of Participants With an American College of Rheumatology 20%, 50%, or 70% (ACR20/ACR50/ACR70) Response
Description
ACR20/50/70 response: ≥20%, 50%, or 70% improvement, respectively, in swollen and tender joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP).
Time Frame
Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in Swollen and Tender Joint Counts at Week 24
Description
Swollen joint count: 66 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66.
Tender joint counts: 68 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68.
Time Frame
Week 24
Title
Change From Baseline in the Levels of C-Reactive Protein at Week 24
Description
The serum concentration of CRP is measured in mg/L. A reduction in the level was considered an improvement.
Time Frame
Week 24
Title
Change From Baseline in Participant's Global Assessment of Pain (VAS) at Week 24
Description
Participant's global assessment of pain was assessed using a 100-mm horizontal VAS (0 to 100 mm) with 0=pain absent and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their current level of pain.
Time Frame
Week 24
Title
Change From Baseline in Participant and Physician Assessment of Global Disease Activity (VAS) at Week 24
Description
Participant's global assessment of disease activity was an overall assessment of their current disease activity on a 100-mm horizontal VAS scale (left-hand extreme: "no disease activity"; right-hand extreme: "maximum disease activity").
Physician's global assessment of disease activity was measured as participant's current disease activity on a 100-mm horizontal VAS scale (left hand extreme: "no disease activity"; right-hand extreme: "maximum disease activity").
Time Frame
Week 24
Title
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Description
CDAI was calculated according to the following formula:
CDAI = Number of swollen joints (plus) + Number of tender joints + VAS disease activity participant assessment + VAS disease activity investigator assessment. The maximum score was 334 (66 joints + 68 joints + 100 mm + 100 mm); higher scores indicated higher disease activity.
Time Frame
Weeks 1, 2, 4, 8, 12, 16, 20 and 24
Title
Change From Baseline in HAQ-DI at Week 24
Description
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame
Week 24
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 24
Description
FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participant's fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). 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
Week 24
Title
Change From Baseline in Short Form-36 (SF-36) Score at Week 24
Description
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Absolute change was defined as the change from baseline to Week 24.
Time Frame
Week 24
Title
Participant's Global Assessment of Pain as Assessed by Patient Take Home Form (PTHF)
Description
Participant's were asked to state the worst level of pain felt in the past 24 hours using a 100-mm horizontal VAS (0 to 100 mm) with 0=no pain and 100=unbearable pain. Participants responded by placing a mark on the line to indicate their level of pain. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.
Time Frame
Baseline and Weeks 1, 2, and 4
Title
Duration of Morning Stiffness as Assessed Using PTHF
Description
Duration of morning stiffness: participants were asked 'how long did your morning stiffness last from the time you woke up yesterday' and the response was provided in minutes and hours. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.
Time Frame
Baseline, Weeks 1, 2, and 4
Title
Participant Assessment of Fatigue/Tiredness as Assessed Using PTHF
Description
Participants were asked to assess their overall level of fatigue/tiredness during the previous 24 hours using a 100-mm horizontal VAS with 0=none and 100=very severe. Participants responded by placing a mark on the line to indicate their current level of fatigue. Participants were asked to document their response during the first 4 treatment weeks at approximately the same time every day.
Time Frame
Baseline and Weeks 1, 2 and 4
Title
Treatment Satisfaction Questionnaire for Medication (TSQM) Score
Description
The TSQM is a general measure of participants treatment satisfaction and consists of 14 questions that result in 4 subscales: "effectiveness", "side-effects", "convenience" and "global satisfaction". All subscale scores range from 0 to 100%, with 100% being the best possible result.
Time Frame
Week 24
Title
Changes in Hemoglobin
Description
Hemoglobin levels were determined as a hematology parameter to measure changes in disease related anemia.
Time Frame
Baseline, Weeks 1, 2, 4 and 24
Title
Changes in C-Reactive Protein
Description
CRP is an acute phase inflammatory marker used as a measure of inflammation. A reduction in CRP is considered to be an improvement.
Time Frame
Baseline, Weeks 1, 2 ,4 and 24
Title
Changes in Erythrocyte Sedimentation Rate (ESR)
Description
ESR is an inflammation marker used to determine acute phase response.
Time Frame
Baseline, Weeks 1, 2, 4 and 24
Title
Percentage of Participants Withdrawing From Study Treatment Because of Insufficient Therapeutic Response
Description
Participants who withdrew from study drug due to other reasons were not taken into account.
Time Frame
Weeks 1, 2, 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:
adult patients, >=18 years of age;
rheumatoid arthritis of >=6 months duration diagnosed according to the revised 1987 ACR criteria;
DAS28 of >3.2;
At screening either ESR >=28 mm/h or CRP >=1 mg/dL;
Having received permitted DMARDs, 1 or more; current DMARD therapy must have been at a stable dose for at least 8 weeks prior to baseline.
Exclusion Criteria:
major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following screening;
functional class IV as identified by the ACR classification of functional status in RA;
rheumatoid autoimmune disease other than RA;
prior history of or current inflammatory joint disease other than 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
Aachen
ZIP/Postal Code
52064
Country
Germany
City
Bad Abbach
ZIP/Postal Code
93077
Country
Germany
City
Bad Aibling
ZIP/Postal Code
83043
Country
Germany
City
Bad Bramstedt
ZIP/Postal Code
24576
Country
Germany
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
City
Baden-baden
ZIP/Postal Code
76530
Country
Germany
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
12161
Country
Germany
City
Berlin
ZIP/Postal Code
12435
Country
Germany
City
Berlin
ZIP/Postal Code
13055
Country
Germany
City
Berlin
ZIP/Postal Code
13125
Country
Germany
City
Berlin
ZIP/Postal Code
14109
Country
Germany
City
Berlin
ZIP/Postal Code
14163
Country
Germany
City
Bremen
ZIP/Postal Code
28199
Country
Germany
City
Cuxhaven
ZIP/Postal Code
27476
Country
Germany
City
Damp
ZIP/Postal Code
24351
Country
Germany
City
Donaueschingen
ZIP/Postal Code
78166
Country
Germany
City
Dresden
ZIP/Postal Code
01067
Country
Germany
City
Dresden
ZIP/Postal Code
01109
Country
Germany
City
Dresden
ZIP/Postal Code
01307
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40217
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
City
Erfurt
ZIP/Postal Code
99096
Country
Germany
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
City
Erlangen
ZIP/Postal Code
91056
Country
Germany
City
Essen
ZIP/Postal Code
45239
Country
Germany
City
Frankfurt Am Main
ZIP/Postal Code
60590
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Fulda
ZIP/Postal Code
36039
Country
Germany
City
Gommern
ZIP/Postal Code
39245
Country
Germany
City
Goslar
ZIP/Postal Code
38642
Country
Germany
City
Grafschaft
ZIP/Postal Code
53501
Country
Germany
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
City
Hagen
ZIP/Postal Code
58135
Country
Germany
City
Halle
ZIP/Postal Code
06108
Country
Germany
City
Halle
ZIP/Postal Code
06120
Country
Germany
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
City
Hamburg
ZIP/Postal Code
22147
Country
Germany
City
Hamburg
ZIP/Postal Code
22609
Country
Germany
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Herne
ZIP/Postal Code
44652
Country
Germany
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
City
Hofheim
ZIP/Postal Code
65719
Country
Germany
City
Homburg/saar
ZIP/Postal Code
66424
Country
Germany
City
Hoyerswerda
ZIP/Postal Code
02977
Country
Germany
City
Köln
ZIP/Postal Code
50679
Country
Germany
City
Köln
ZIP/Postal Code
50924
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Ludwigsfelde
ZIP/Postal Code
14974
Country
Germany
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
City
Lüneburg
ZIP/Postal Code
21335
Country
Germany
City
Mainz
ZIP/Postal Code
55122
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Marburg
ZIP/Postal Code
35037
Country
Germany
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
City
München
ZIP/Postal Code
80335
Country
Germany
City
München
ZIP/Postal Code
81541
Country
Germany
City
München
ZIP/Postal Code
81925
Country
Germany
City
Münster
ZIP/Postal Code
48149
Country
Germany
City
Naunhof
ZIP/Postal Code
04683
Country
Germany
City
Neuss
ZIP/Postal Code
41460
Country
Germany
City
Nürnberg
ZIP/Postal Code
90402
Country
Germany
City
Oberammergau
ZIP/Postal Code
82487
Country
Germany
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
City
Pirna
ZIP/Postal Code
01796
Country
Germany
City
Plochingen
ZIP/Postal Code
73207
Country
Germany
City
Potsdam
ZIP/Postal Code
14469
Country
Germany
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
City
Rostock
ZIP/Postal Code
18059
Country
Germany
City
Sendenhorst
ZIP/Postal Code
48324
Country
Germany
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
City
Stuttgart
ZIP/Postal Code
70372
Country
Germany
City
Treuenbrietzen
ZIP/Postal Code
14929
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
ULM
ZIP/Postal Code
89081
Country
Germany
City
Wiesbaden
ZIP/Postal Code
65189
Country
Germany
City
Würselen
ZIP/Postal Code
52146
Country
Germany
City
Zeven
ZIP/Postal Code
27404
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.
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