Back to resultsA Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
tocilizumab [RoActemra/Actemra]
DMARDs (disease-modifying antirheumatic drugs)
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 of >/=6 months duration
- inadequate clinical response to current non-biologic DMARDs
- current DMARDs must be at stable dose for 8 weeks prior to study entry
- oral corticosteroids (</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for >/=4 weeks prior to screening
Exclusion Criteria:
- rheumatic autoimmune disease other than RA
- history of or current inflammatory joint disease other than RA
- previous treatment with any biologic DMARD
- functional class IV as defined by the ACR classification
- intra-articular or parenteral corticosteroids within 6 weeks prior to screening
Sites / Locations
- Chelyabinsk Regional Clinical Hospital; Rheumatology
- Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department
- Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
- Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept
- Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
- Republican Clinicodiagnostic Center
- Kaliningrad Regional Clinical Hospital; Rheumatologic Department
- War Veterans Regional Clinical Hospital;Therapy Department
- Kirov Regional Clinical Hospital; Reumatology Department
- GUZ Regional clinical hospital # 1
- GMU Kursk regional clinical hospital
- FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
- FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
- FGU Central Clinical Hospital with Polyclinic Administration President RF
- Head Clinical Hospital of Internal Affair Ministry of Russia
- Vladimirskiy Regional Scientific Research Inst.
- SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko
- Republican Hospital Named After V.A. Baranov
- Rostov State Medical University; Cardiorheumatology Department
- Clinical hospital #1
- Surgut Region Clinical Hospital
- Glpu Tjumen Regional Clinical Hospital #1
- Republican clinical hospital named after G.G. Kuvatov
- State Institution of Healthcare Ulyanovsk Regional Clinical Hospital
- GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological
- Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
- Voronezh Regional Clinical Hospital #1
- SHI Yaroslavl Regional Clinical Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Health Assessment Questionnaire (HAQ) Score
HAQ 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. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.
Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment
HAQ 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=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.
Change in HAQ Score at Week 24
HAQ 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=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.
Secondary Outcome Measures
Pain Score as Assessed by Visual Analogue Scale (VAS)
Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.
European Quality of Life - 5 Dimensions (EQ-5D) Score
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Change in EQ-5D Score at Week 24 From Baseline
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.
General Health Score as Assessed by EQ-5D VAS
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.
Change in General Health Assessed by VAS
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Disease Activity Score Based on 28-Joint Count (DAS28)
DAS28 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 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Change in DAS28 Score From Baseline to Week 24
Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment
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 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1).
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and 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 HAQ); and acute phase response: C-reactive protein (CRP) or ESR.
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1.
C-Reactive Protein
CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.
Erythrocyte Sedimentation Rate
ESR (mm/hr) is used to determine the acute phase response.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00996203
Brief Title
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
Official Title
Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
October 31, 2009 (Actual)
Primary Completion Date
February 14, 2011 (Actual)
Study Completion Date
February 14, 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 evaluate the efficacy and safety of tocilizumab added to traditional disease-modifying antirheumatic drugs (DMARDs) in patients with moderate to severe active rheumatoid arthritis and an inadequate response to DMARDs. Patients will receive tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 24 weeks, in addition to their current non-biologic DMARDs at stable doses. Anticipated time on study treatment is 24 weeks, and the target sample size is 200.
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra/Actemra]
Intervention Description
8 mg/kg iv every 4 weeks for 24 weeks
Intervention Type
Drug
Intervention Name(s)
DMARDs (disease-modifying antirheumatic drugs)
Intervention Description
stable doses at investigator's prescription
Primary Outcome Measure Information:
Title
Health Assessment Questionnaire (HAQ) Score
Description
HAQ 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. Withdrawal Visit is the final visit prior to the withdrawal of the subject from the study.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24 and Withdrawal Visit
Title
Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment
Description
HAQ 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=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
Weeks 4, 8, 12, 16, 20, and 24
Title
Change in HAQ Score at Week 24
Description
HAQ 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=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 and Week 24
Secondary Outcome Measure Information:
Title
Pain Score as Assessed by Visual Analogue Scale (VAS)
Description
Participant's global assessment of pain was assessed using a 100-millimeter (mm) horizontal VAS (0 to 100 mm) with 0=pain absent and 100=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
European Quality of Life - 5 Dimensions (EQ-5D) Score
Description
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
Change in EQ-5D Score at Week 24 From Baseline
Description
EQ-5D questionnaire assess 5 domains of quality of life including mobility, self-care, habitual daily activities, pain, discomfort, and anxiety/depression. Each of five domains was assessed by 3 levels depending on severity of a problem and scored using the following: 1=no disturbances, 2=moderate disturbances, 3=severe disturbances. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Minimum clinically significant change in EQ-5D corresponds to the parameter differences before and after treatment = 0.10. Graduations of assessment of the therapy efficacy by EQ-5D are: Difference (Δ) EQ-5D less than (<)0.10 points: none; 0.10 less than or equal to (≤)Δ EQ-5D ≤0.24: minimal effect; 0.24≤ Δ EQ-5D <0.31: satisfactory effect; Δ EQ-5D greater than or equal to (≥)0.31 points: pronounced effect.
Time Frame
Baseline and Week 24
Title
General Health Score as Assessed by EQ-5D VAS
Description
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D
Description
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality. Positive response was defined as an increase of EQ-5D score by 0.1 or more i.e. it is a clinically significant increase.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
Change in General Health Assessed by VAS
Description
Participant-reported general health quality was assessed using an EQ-5D 100-mm horizontal VAS (0 to 100 mm) with 0=worst health state and 100=the best health state. The participants were asked to mark the line that corresponded to assessment of general health quality.
Time Frame
Baseline and Week 24
Title
Disease Activity Score Based on 28-Joint Count (DAS28)
Description
DAS28 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 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
Change in DAS28 Score From Baseline to Week 24
Time Frame
Baseline and Week 24
Title
Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment
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 10-mm VAS); DAS28 score ranged from 0 to 10, where higher scores correspond to greater disease activity. Disease activity: 0=remission (DAS28 less than [<] 2.6), I=low (DAS28 less than or equal to [≤]2.6 to <3.2), II=moderate (DAS28=3.2 to 5.1), III=high (DAS28 greater than [>]5.1).
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
Description
ACR20/50/70 response: ≥20%, ≥50%, or ≥70% improvement, respectively, in swollen/tender joint count (66 joints assessed for swelling and 68 joints assessed for tenderness) and 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 HAQ); and acute phase response: C-reactive protein (CRP) or ESR.
Time Frame
Weeks 0, 4, 8, 12, 16, 20, and 24
Title
Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
Description
The DAS28-based EULAR response criteria were used to measure individual response as no effect, good effect, and moderate effect, depending on the extent of change from baseline and the level of disease activity reached. Good effect: change from baseline >1.2 with DAS28 score ≤3.2; moderate effect: change from baseline >1.2 with DAS28 score 3.2 to 5.1 or change from baseline >0.6 to <1.2 with DAS28 score <3.2; no effect: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 score >5.1.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
C-Reactive Protein
Description
CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.
Time Frame
Weeks 4, 8, 12, 16, 20, and 24
Title
Erythrocyte Sedimentation Rate
Description
ESR (mm/hr) is used to determine the acute phase response.
Time Frame
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:
adult patients, >/= 18 years of age
moderate to severe active rheumatoid arthritis of >/=6 months duration
inadequate clinical response to current non-biologic DMARDs
current DMARDs must be at stable dose for 8 weeks prior to study entry
oral corticosteroids (</=10mg/day prednisone or equivalent) and NSAIDs must be at stable dose for >/=4 weeks prior to screening
Exclusion Criteria:
rheumatic autoimmune disease other than RA
history of or current inflammatory joint disease other than RA
previous treatment with any biologic DMARD
functional class IV as defined by the ACR classification
intra-articular or parenteral corticosteroids within 6 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:
Facility Name
Chelyabinsk Regional Clinical Hospital; Rheumatology
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Republican clinical hospital of Karachai-Cherkess; Rheumatologic Department
City
Cherkess
ZIP/Postal Code
369000
Country
Russian Federation
Facility Name
Municipal Autonomous Institution of Healthcare "City Clinical Hospital #40"
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital # 1; Rheumatology Dept
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
City
Irkutsk
ZIP/Postal Code
664047
Country
Russian Federation
Facility Name
Republican Clinicodiagnostic Center
City
Izhevsk
ZIP/Postal Code
426009
Country
Russian Federation
Facility Name
Kaliningrad Regional Clinical Hospital; Rheumatologic Department
City
Kaliningrad
ZIP/Postal Code
236016
Country
Russian Federation
Facility Name
War Veterans Regional Clinical Hospital;Therapy Department
City
Kemerovo
ZIP/Postal Code
650099
Country
Russian Federation
Facility Name
Kirov Regional Clinical Hospital; Reumatology Department
City
Kirov
ZIP/Postal Code
610028
Country
Russian Federation
Facility Name
GUZ Regional clinical hospital # 1
City
Krasnodar
ZIP/Postal Code
350086
Country
Russian Federation
Facility Name
GMU Kursk regional clinical hospital
City
Kursk
ZIP/Postal Code
305007
Country
Russian Federation
Facility Name
FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
FSBI "FSCC of particularized sorts of medical care and medical technologies of FMBA"
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
FGU Central Clinical Hospital with Polyclinic Administration President RF
City
Moscow
ZIP/Postal Code
121359
Country
Russian Federation
Facility Name
Head Clinical Hospital of Internal Affair Ministry of Russia
City
Moscow
ZIP/Postal Code
123060
Country
Russian Federation
Facility Name
Vladimirskiy Regional Scientific Research Inst.
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
SIH Nizhny Novgorod Regional Clinical Hospital n.a. Semashko
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Republican Hospital Named After V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Rostov State Medical University; Cardiorheumatology Department
City
Rostov-na-Donu
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Clinical hospital #1
City
Smolensk
ZIP/Postal Code
214001
Country
Russian Federation
Facility Name
Surgut Region Clinical Hospital
City
Surgut
ZIP/Postal Code
628408
Country
Russian Federation
Facility Name
Glpu Tjumen Regional Clinical Hospital #1
City
Tjumen
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Republican clinical hospital named after G.G. Kuvatov
City
UFA
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
State Institution of Healthcare Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
GUZ "Novgorod Regional Clinical Hospital"; Cardioreumatological
City
Veliky Novgorod
ZIP/Postal Code
173008
Country
Russian Federation
Facility Name
Budget Institution of Healthcare of Voronezh Region "Voronezh Regional Clinical Hospital #1"
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
Voronezh Regional Clinical Hospital #1
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
SHI Yaroslavl Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.
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