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A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00996203
Recruitment Status : Completed
First Posted : October 16, 2009
Results First Posted : July 2, 2014
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: tocilizumab [RoActemra/Actemra]
Drug: DMARDs (disease-modifying antirheumatic drugs)
Enrollment 201
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tocilizumab
Hide Arm/Group Description Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (but not more than 800 mg), intravenously (IV), every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Period Title: Overall Study
Started 201
Completed 194
Not Completed 7
Reason Not Completed
Adverse Event             3
Lost to Follow-up             1
Lack of Efficacy             1
Protocol Violation             2
Arm/Group Title Tocilizumab
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Baseline Participants 201
Hide Baseline Analysis Population Description
Safety population: All patients who received at least one dose and had at least one safety assessment after the drug administration.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants
49.0  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants
Female
174
  86.6%
Male
27
  13.4%
1.Primary Outcome
Title Health Assessment Questionnaire (HAQ) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: All participants randomized in the study who received administration of at least one dose of the study drug and who had at least one efficacy assessment performed. n (number) = number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 (n=201) 1.93  (0.60)
Week 4 (n=199) 1.49  (0.65)
Week 8 (n=198) 1.22  (0.63)
Week 12 (n=196) 1.08  (0.62)
Week 16 (n=193) 1.00  (0.60)
Week 20 (n=193) 0.90  (0.61)
Week 24 (n=193) 0.84  (0.62)
Withdrawal visit (n=6) 1.32  (1.13)
2.Primary Outcome
Title Percentage of Participants With an HAQ Score Decrease of 20 Percent (%), 50%, and 70% During Tocilizumab Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population:
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 199
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 ≥20% (n=199) 51.8
Week 4 ≥50% (n=199) 15.6
Week 4 ≥70% (n=199) 5.0
Week 8 ≥20% (n=198) 72.2
Week 8 ≥50% (n=198) 28.8
Week 8 ≥70% (n=198) 13.6
Week 12 ≥ 20% (n=196) 83.7
Week 12 ≥50% (n=196) 42.3
Week 12 ≥70% (n=196) 18.9
Week 16 ≥20% (n=193) 86.5
Week 16 ≥50% (n=193) 51.3
Week 16 ≥70% (n=193) 21.8
Week 20 ≥20% (n=193) 89.6
Week 20 ≥50% (n=193) 56.0
Week 20 ≥70% (n=193) 34.2
Week 24 ≥20% (n=193) 88.1
Week 24 ≥50% (n=193) 61.7
Week 24 ≥70% (n=193) 38.3
3.Primary Outcome
Title Change in HAQ Score at Week 24
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.11  (0.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tocilizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Mean HAQ scores at Baseline Versus Week 24
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Pain Score as Assessed by Visual Analogue Scale (VAS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: mm
Week 0 (n=201) 63.82  (16.71)
Week 4 (n=199) 46.36  (20.57)
Week 8 (n=198) 36.48  (18.94)
Week 12 (n=196) 31.90  (19.83)
Week 16 (n=193) 26.92  (18.87)
Week 20 (n=193) 24.63  (19.09)
Week 24 (n=193) 21.96  (18.87)
Withdrawal visit (n=6) 34.50  (22.00)
5.Secondary Outcome
Title European Quality of Life - 5 Dimensions (EQ-5D) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 (n=200) 0.29  (0.31)
Week 4 (n=199) 0.49  (0.24)
Week 8 (n=198) 0.57  (0.20)
Week 12 (n=196) 0.61  (0.21)
Week 16 (n=193) 0.64  (0.19)
Week 20 (n=193) 0.66  (0.18)
Week 24 (n=193) 0.69  (0.20)
Withdrawal visit (n=4) 0.61  (0.07)
6.Secondary Outcome
Title Change in EQ-5D Score at Week 24 From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.41  (0.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tocilizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments EQ-5D scores at Baseline Versus Week 24
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title General Health Score as Assessed by EQ-5D VAS
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: mm
Week 0 (n=201) 39.27  (18.03)
Week 4 (n=199) 50.93  (18.78)
Week 8 (n=198) 61.79  (43.45)
Week 12 (n=196) 66.13  (19.91)
Week 16 (n=193) 70.48  (19.39)
Week 20 (n=192) 73.31  (19.58)
Week 24 (n=193) 76.22  (19.25)
Withdrawal visit (n=4) 60.50  (27.77)
8.Secondary Outcome
Title Percentage of Participants Achieving a Positive Response on Health Quality Assessment of EQ-5D
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 198
Measure Type: Number
Unit of Measure: percentage of Participants
Week 4 (n=198) 42.9
Week 8 (n=198) 55.6
Week 12 (n=196) 60.2
Week 16 (n=193) 65.8
Week 20 (n=193) 68.4
Week 24 (n=193) 73.1
9.Secondary Outcome
Title Change in General Health Assessed by VAS
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: mm
37.3  (25.75)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tocilizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments General health at baseline Versus Week 24
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Disease Activity Score Based on 28-Joint Count (DAS28)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 (n=199) 6.748  (0.852)
Week 4 (n=197) 4.665  (1.227)
Week 8 (n=196) 3.777  (1.279)
Week 12 (n=193) 3.347  (1.208)
Week 16 (n=193) 2.956  (1.230)
Week 20 (n=192) 2.762  (1.111)
Week 24 (n=191) 2.637  (1.157)
11.Secondary Outcome
Title Change in DAS28 Score From Baseline to Week 24
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.097  (1.289)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tocilizumab
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Baseline Versus Week 24 DAS28 scores
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Patients With Varied Disease Activity Assessed Using DAS28 During Tocilizumab Treatment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 199
Measure Type: Number
Unit of Measure: percentage of participants
Week 0 moderate activity (n=199) 2.5
Week 0 high activity (n=199) 97.5
Week 4 remission (n=197) 3.0
Week 4 low activity (n=197) 9.6
Week 4 moderate activity (n=197) 52.8
Week 4 high activity (n=197) 34.5
Week 8 remission (n=196) 17.9
Week 8 low activity (n=196) 15.3
Week 8 moderate activity (n=196) 51.5
Week 8 high activity (n=196) 15.3
Week 12 remission (n=193) 25.4
Week 12 low activity (n=193) 22.8
Week 12 moderate activity (n=193) 42.0
Week 12 high activity (n=193) 9.8
Week 16 remission (n=193) 41.5
Week 16 low activity (n=193) 19.2
Week 16 moderate activity (n=193) 33.2
Week 16 high activity (n=193) 6.2
Week 20 remission (n=192) 44.8
Week 20 low activity (n=192) 20.8
Week 20 moderate activity (n=192) 30.7
Week 20 high activity (n=192) 3.6
Week 24 remission (n=191) 51.3
Week 24, low activity (n=191) 19.4
Week 20 moderate activity (n=191) 26.7
Week 24 high activity (n=191) 2.6
13.Secondary Outcome
Title Percentage of Participants Achieving American College of Rheumatology 20% (ACR20), 50% (ACR50), and 70% (ACR70) Response
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: percentage of participants
ACR20 Week 4 50.2
ACR20 Week 8 76.1
ACR20 Week 12 81.1
ACR20 Week 16 89.6
ACR20 Week 20 91.0
ACR20 Week 24 89.1
ACR50 Week 4 9.5
ACR50 Week 8 27.4
ACR50 Week 12 49.3
ACR50 Week 16 61.2
ACR50 Week 20 67.7
ACR50 Week 24 70.6
ACR70 Week 4 3.0
ACR70 Week 8 10.0
ACR70 Week 12 18.4
ACR70 Week 16 26.9
ACR70 Week 20 39.3
ACR70 Week 24 44.3
14.Secondary Outcome
Title Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: percentage of participants
Week 4, No effect (n=195) 15.9
Week 4, Moderate effect (n=195) 72.3
Week 4, Good effect (n=195) 11.8
Week 8, No effect (n=194) 5.7
Week 8, Moderate effect (n=194) 61.9
Week 8, Good effect (=194) 32.5
Week 12, No effect (n=191) 4.7
Week 12, Moderate effect (n=191) 47.6
Week 12, Good effect (n=191) 47.6
Week 16, No effect (n=191) 2.1
Week 16, Moderate effect (n=191) 37.7
Week 16, Good effect (n=191) 60.2
Week 20, No effect (n=190) 0.5
Week 20, Moderate effect (n=190) 34.2
Week 20, Good effect (n=190) 65.3
Week 24, No effect (n=189) 1.1
Week 24, Moderate effect (n=189) 28.6
Week 24, Good effect (n=189) 70.4
15.Secondary Outcome
Title C-Reactive Protein
Hide Description CRP (milligrams/Liter) is a mediator of inflammation, acute phase protein.
Time Frame Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 200
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 0 (n=200) 33.51  (34.86)
Week 4 (n=198) 8.67  (15.00)
Week 8 (n=194) 7.62  (19.00)
Week 12 (n=196) 5.43  (16.69)
Week 16 (n=191) 4.66  (13.48)
Week 20 (n=193) 4.92  (14.29)
Week 24 (n=189) 4.78  (12.94)
Withdrawal visit (n=6) 7.00  (0.20)
16.Secondary Outcome
Title Erythrocyte Sedimentation Rate
Hide Description ESR (mm/hr) is used to determine the acute phase response.
Time Frame Weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population; n=number of participants assessed at a specific visit.
Arm/Group Title Tocilizumab
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
Overall Number of Participants Analyzed 201
Mean (Standard Deviation)
Unit of Measure: mm/hr
Week 0 (n=201) 53.33  (30.82)
Week 4 (n=198) 15.29  (13.77)
Week 8 (n=197) 11.97  (14.95)
Week 12 (n=193) 10.00  (10.82)
Week 16 (n=193) 11.63  (17.99)
Week 20 (n=193) 10.71  (13.24)
Week 24 (n=193) 10.95  (13.52)
Withdrawal visit (n=6) 15.00  (4.00)
Time Frame From baseline Visit up to 24 weeks or until withdrawal
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tocilizumab
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
All-Cause Mortality
Tocilizumab
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Tocilizumab
Affected / at Risk (%)
Total   12/201 (5.97%) 
Blood and lymphatic system disorders   
Thrombocytopenia * 1  1/201 (0.50%) 
Hepatobiliary disorders   
Toxic hepatitis * 1  1/201 (0.50%) 
Immune system disorders   
Anaphylactic shock * 1  1/201 (0.50%) 
Infections and infestations   
Localized infection * 1  1/201 (0.50%) 
Wound infection * 1  1/201 (0.50%) 
Acute pyelonephritis * 1  1/201 (0.50%) 
Subcutaneous abscess * 1  1/201 (0.50%) 
Pneumonia * 1  1/201 (0.50%) 
Musculoskeletal and connective tissue disorders   
Fracture * 1  1/201 (0.50%) 
Nervous system disorders   
Cervical myelopathy * 1  1/201 (0.50%) 
Respiratory, thoracic and mediastinal disorders   
Chronic bronchitis * 1  1/201 (0.50%) 
Skin and subcutaneous tissue disorders   
Erysipelatous inflammation * 1  1/201 (0.50%) 
Vascular disorders   
Hemorrhagic anemia * 1  1/201 (0.50%) 
Venous thrombosis * 1  1/201 (0.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tocilizumab
Affected / at Risk (%)
Total   46/201 (22.89%) 
Blood and lymphatic system disorders   
Lymphostasis * 1  1/201 (0.50%) 
Thrombocytopenia * 1  3/201 (1.49%) 
Lymphopenia * 1  1/201 (0.50%) 
Anaemia * 1  2/201 (1.00%) 
Leukopenia * 1  2/201 (1.00%) 
Neutropenia * 1  2/201 (1.00%) 
Eye disorders   
Keratitis * 1  1/201 (0.50%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/201 (0.50%) 
Hepatobiliary disorders   
Hyperbilirubinaemia * 1  1/201 (0.50%) 
Immune system disorders   
Hypersensitivity * 1  1/201 (0.50%) 
Infections and infestations   
Oral herpes * 1  2/201 (1.00%) 
Respiratory tract infection * 1  6/201 (2.99%) 
Respiratory tract infection viral * 1  6/201 (2.99%) 
Acute tonsillitis * 1  1/201 (0.50%) 
Pharyngitis * 1  2/201 (1.00%) 
Onychomycosis * 1  1/201 (0.50%) 
Tracheitis * 1  1/201 (0.50%) 
Investigations   
Blood pressure increased * 1  2/201 (1.00%) 
Transaminases increased * 1  8/201 (3.98%) 
Alanine aminotransferase increased * 1  9/201 (4.48%) 
Aspartate aminotransferase increased * 1  5/201 (2.49%) 
Metabolism and nutrition disorders   
Hypercholesterolaemia * 1  1/201 (0.50%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/201 (0.50%) 
Lower limb fracture * 1  1/201 (0.50%) 
Upper limb fracture * 1  1/201 (0.50%) 
Synovitis * 1  1/201 (0.50%) 
Renal and urinary disorders   
Pyelonephritis chronic * 1  1/201 (0.50%) 
Renal colic * 1  1/201 (0.50%) 
Reproductive system and breast disorders   
Prostatitis * 1  1/201 (0.50%) 
Respiratory, thoracic and mediastinal disorders   
Bronchitis chronic * 1  1/201 (0.50%) 
Skin and subcutaneous tissue disorders   
Rash * 1  1/201 (0.50%) 
Skin reactions * 1  1/201 (0.50%) 
Surgical and medical procedures   
Tooth extraction * 1  1/201 (0.50%) 
Vascular disorders   
Haemorrhoids * 1  1/201 (0.50%) 
Hypertension * 1  1/201 (0.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann- LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00996203    
Other Study ID Numbers: ML22665
First Submitted: October 15, 2009
First Posted: October 16, 2009
Results First Submitted: April 7, 2014
Results First Posted: July 2, 2014
Last Update Posted: March 29, 2018