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Trial record 46 of 1643 for:    Slovakia

A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.

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ClinicalTrials.gov Identifier: NCT01010503
Recruitment Status : Completed
First Posted : November 10, 2009
Results First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: tocilizumab [RoActemra/Actemra]
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tocilizumab 8 Milligrams Per Kilogram (mg/kg)
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Period Title: Overall Study
Started 32
Completed 30
Not Completed 2
Reason Not Completed
Adverse Event             1
Death             1
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
52.38  (12.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
26
  81.3%
Male
6
  18.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
32
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovakia Number Analyzed 32 participants
32
Disease Duration  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
11.97  (10.55)
Disease Phase/Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Phase/Stage I 4
Phase/Stage II 12
Phase/Stage III 12
Phase/Stage IV 4
[1]
Measure Description: Disease stages/phases of rheumatoid arthritis (RA): Stage I represents synovitis: synovial membrane becomes hyperemic and edematous; joint effusions with high cell count; x-rays will as yet show no destructive changes, but soft tissue swelling or osteoporosis may be seen; Stage II: inflamed synovial tissue now proliferates and begins to grow into joint cavity across articular cartilage, which it gradually destroys; Stage III: pannus of synovium; eroded articular cartilage and exposed subchondral bone x-rays will show extensive cartilage loss; Stage IV represents end-stage disease.
Functional Class of Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Class I 0
Class II 10
Class III 22
Class IV 0
[1]
Measure Description: Classification of global functional status in RA is as follows: Class I: completely able to perform usual activities of daily living (self-care, vocational, and avocational); Class II: able to perform usual self-care and vocational activities, but limited in avocational activities; Class III: able to perform usual self-care activities, but limited in vocational and avocational activities; and Class IV: limited in ability to perform usual self-care, vocational, and avocational activities.
C-Reactive Protein (CRP)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 32 participants
17.84  (21.30)
[1]
Measure Description: CRP was measured in milligrams per liter (mg/L)
Erythrocyte Sedimentation Rate (ESR)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm/hr
Number Analyzed 32 participants
55.81  (25.05)
[1]
Measure Description: ESR was measured in millimeters per hour (mm/hr)
1.Primary Outcome
Title Percentage of Participants Adherent to Original Treatment
Hide Description Adherence rate to original treatment according to the protocol included all participants that received the study drug beginning from Week 8 and remaining until the end of the study. This number represents participants with no changes in treatment protocol, participants with treatment discontinuation, and participants with dose reduction, but not participants that withdrew from the study prematurely.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population (ITT), all enrolled participants who received at least one dose of study drug
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
93.75
2.Primary Outcome
Title Percentage of Participants Receiving Less Than or Equal to (≤) 1 Dose of Study Drug Who Discontinued Treatment for Any Reason
Hide Description [Not Specified]
Time Frame Weeks 0, 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
3.13
3.Primary Outcome
Title Percentage of Participants Receiving Greater Than (>) 1 Dose Who Discontinued Treatment for Any Reason
Hide Description [Not Specified]
Time Frame Weeks 0, 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
0
4.Primary Outcome
Title Percentage of Participants Withdrawing From the Study Prematurely for Any Reason
Hide Description [Not Specified]
Time Frame Weeks 0, 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
6.25
5.Primary Outcome
Title Percentage of Participants With Dose Reduction to Tocilizumab 4 mg/kg
Hide Description [Not Specified]
Time Frame Weeks 0, 4, 8, 12, 16, and 20
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: percentage of participants
18.75
6.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 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. DAS28 ≤3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
Time Frame Weeks 0, 4, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 (n=32) 7.02  (0.66)
Week 4 (n=32) 4.30  (1.04)
Week 12 (n=30) 2.85  (1.11)
Week 24 (n=30) 2.57  (0.91)
7.Secondary Outcome
Title Patient Global Assessment of Pain
Hide Description Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.
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 for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 (n=32) 59.91  (14.66)
Week 4 (n=32) 36.31  (17.10)
Week 8 (n=30) 22.3  (15.79)
Week 12 (n=30) 17.30  (14.00)
Week 16 (n=30) 18.93  (14.59)
Week 20 (n=30) 16.73  (15.11)
Week 24 (n=30) 14.87  (11.32)
8.Secondary Outcome
Title Patient Global Assessment of Disease Activity
Hide Description The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.
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 for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 (n=32) 61.75  (11.76)
Week 4 (n=32) 35.59  (16.62)
Week 8 (n=30) 22.20  (14.86)
Week 12 (n=30) 18.20  (14.57)
Week 16 (n=30) 18.80  (13.42)
Week 20 (n=30) 18.13  (18.49)
Week 24 (n=30) 15.47  (12.62)
9.Secondary Outcome
Title Physician's Global Assessment of Disease Activity
Hide Description Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.
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 for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Week 0 (n=32) 59.63  (7.89)
Week 4 (n=32) 27.75  (14.00)
Week 8 (n=30) 17.40  (9.96)
Week 12 (n=30) 14.20  (9.93)
Week 16 (n=30) 13.00  (8.68)
Week 20 (n=30) 12.77  (10.17)
Week 24 (n=30) 12.47  (8.22)
10.Secondary Outcome
Title Swollen Joint Count (SJC)
Hide Description The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.
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 for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: swollen joints
Week 0 (n=32) 26.66  (7.11)
Week 4 (n=32) 12.03  (8.24)
Week 8 (n=30) 7.00  (6.52)
Week 12 (n=30) 5.33  (6.47)
Week 16 (n=30) 5.33  (6.33)
Week 20 (n=30) 4.20  (5.088)
Week 24 (n=30) 4.00  (5.24)
11.Secondary Outcome
Title Tender Joint Count (TJC)
Hide Description The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.
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 for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: tender joints
Week 0 (n=32) 16.16  (5.18)
Week 4 (n=32) 5.53  (5.16)
Week 8 (n=30) 1.97  (2.01)
Week 12 (n=30) 1.30  (1.68)
Week 16 (n=30) 1.00  (1.20)
Week 20 (n=30) 0.83  (1.315)
Week 24 (n=30) 0.63  (1.00)
12.Secondary Outcome
Title Erythrocyte Sedimentation Rate (ESR)
Hide Description ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.
Time Frame Weeks 0, 4, 12, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
TT population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: mm/hr
Week 0 (n=32) 55.81  (25.05)
Week 4 (n=32) 16.69  (10.88)
Week 12 (n=30) 15.23  (14.78)
Week 20 (n=30) 14.17  (17.81)
Week 24 (n=30) 11.00  (7.94)
13.Secondary Outcome
Title C-Reactive Protein (CRP)
Hide Description CRP is an acute phase protein. Levels of CRP increase with inflammation.
Time Frame Weeks 0, 4, 12, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: mg/L
Week 0 (n=32) 17.84  (21.30)
Week 4 (n=32) 5.03  (6.07)
Week 12 (n=30) 5.54  (9.22)
Week 20 (n=30) 6.71  (13.9)
Week 24 (n=30) 2.97  (0.70)
14.Secondary Outcome
Title Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
Hide Description The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
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 for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 0 (n=32) 1.77  (0.43)
Week 4 (n=32) 1.56  (0.49)
Week 8 (n=30) 1.31  (0.65)
Week 12 (n=30) 1.28  (0.65)
Week 16 (n=30) 1.23  (0.64)
Week 20 (n=30) 1.20  (0.644)
Week 24 (n=30) 1.16  (0.63)
15.Secondary Outcome
Title Short Form-36 (SF-36)
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.
Time Frame Weeks 0, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description:
Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Physical Functioning, Week 0 (n=32) 26.08  (18.09)
Physical Functioning, Week 12 (n=30) 44.50  (27.58)
Physical Functioning, Week 24 (n=30) 47.22  (31.92)
Role limits due to physical health, Week 0 (n=32) 6.25  (18.71)
Role limits due to physical health, Week 12 (n=30) 49.17  (45.34)
Role limits due to physical health, Week 24 (n=30) 44.44  (45.60)
Role limits due to emotional prob., Week 0 (n=32) 16.67  (34.23)
Role limits due to emotional prob., Week 12 (n=30) 61.11  (45.34)
Role limits due to emotional prob., Week 24 (n=30) 55.56  (48.47)
Energy/fatigue, Week 0 (n=32) 30.31  (17.93)
Energy/ fatigue, Week 12 (n=30) 48.33  (26.14)
Energy/fatigue, Week 24 (n=30) 50.00  (31.32)
Emotional well-being, Week 0 (n=32) 50.00  (19.10)
Emotional well-being, Week 12 (n=30) 63.70  (24.16)
Emotional well-being, Week 24 (n=30) 65.33  (32.92)
Social functioning, Week 0 (n=32) 39.45  (17.61)
Social functioning, Week 12 (n=30) 60.83  (25.36)
Social functioning, Week 24 (n=30) 62.50  (35.11)
Pain, Week 0 (n=32) 28.67  (15.34)
Pain, Week 12 (n=30) 55.75  (27.63)
Pain, Week 24 (n=30) 56.11  (33.32)
General health, Week 0 (n=32) 38.28  (10.82)
General health, Week 12 (n=30) 46.83  (16.32)
General health, Week 24 (n=30) 46.25  (23.41)
Time Frame Serious adverse events (SAEs) related to study medication were reported irrespective of elapsed time from last administration of study medication. Non-related SAEs were reported during the study period and 28 days after the last dose of study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tocilizumab 8 mg/kg
Hide Arm/Group Description Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
All-Cause Mortality
Tocilizumab 8 mg/kg
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tocilizumab 8 mg/kg
Affected / at Risk (%) # Events
Total   3/32 (9.38%)    
Cardiac disorders   
Congestive heart failure * 1  1/32 (3.13%) 
Infections and infestations   
Crash of left foot local infection of skin and subcutaneous tissue * 1  1/32 (3.13%) 
Bronchopneumonia * 1  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders   
Lumbago * 1  1/32 (3.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tocilizumab 8 mg/kg
Affected / at Risk (%) # Events
Total   10/32 (31.25%)    
Blood and lymphatic system disorders   
Leucopenia+lymphopenia  1  3/32 (9.38%)  3
Hepatobiliary disorders   
Hepatopathy  1  2/32 (6.25%)  2
Infections and infestations   
Acute pulpitis  1  1/32 (3.13%)  2
Reproductive system and breast disorders   
Acute bronchitis  1  3/32 (9.38%)  3
Respiratory, thoracic and mediastinal disorders   
Acute nasopharyngitis  1  1/32 (3.13%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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: NCT01010503     History of Changes
Other Study ID Numbers: ML22508
2009-011520-53
First Submitted: November 9, 2009
First Posted: November 10, 2009
Results First Submitted: April 8, 2014
Results First Posted: August 13, 2014
Last Update Posted: August 13, 2014