Clinical Trial Results:
Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination with Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients with Rheumatoid Arthritis
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Summary
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EudraCT number |
2013-000359-42 |
Trial protocol |
GR |
Global end of trial date |
10 Jul 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
20 Jul 2017
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First version publication date |
20 Jul 2017
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
ML28695
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01941095 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
F. Hoffmann-La Roche AG
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
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Public contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
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Scientific contact |
Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Jul 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
10 Jul 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the trial was to assess the efficacy and safety of subcutaneous (SC) tocilizumab, administered as monotherapy and/or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs) for 52 weeks duration.
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Protection of trial subjects |
The study was conducted in full conformance with the International Conference on Harmonisation (ICH) E6 guideline for Good Clinical Practice (GCP) and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research was conducted, whichever affords the greater protection to the individual. The study complied with the requirements of the ICH E2A guideline (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Nov 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Greece: 97
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Worldwide total number of subjects |
97
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EEA total number of subjects |
97
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
68
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From 65 to 84 years |
29
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||
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Pre-assignment
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Screening details |
A total of 100 participants were enrolled, out of which 97 participants received treatment. Analyses were performed in 97 participants. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Arm title
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Tocilizumab | ||||||||||||||||||||
Arm description |
Participants received tocilizumab 162 milligrams (mg) SC injection once a week (QW) either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
Tocilizumab
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Investigational medicinal product code |
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Other name |
RoActemra, Actemra
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Participants received tocilizumab at a fixed dose of 162 mg SC QW either as monotherapy or in combination with non-biologic
DMARDs.
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Baseline characteristics reporting groups
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Reporting group title |
Tocilizumab
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Reporting group description |
Participants received tocilizumab 162 milligrams (mg) SC injection once a week (QW) either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tocilizumab
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Reporting group description |
Participants received tocilizumab 162 milligrams (mg) SC injection once a week (QW) either as monotherapy or in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. The choice of monotherapy or combination treatment was according to the physician's judgment up to Week 24. Depending upon the participant's response to study regimen at Week 24, participant might either continue/discontinue/switch to tocilizumab monotherapy or may lead to intensification of methotrexate/non-biologic DMARDs with tocilizumab at a fixed dose of 162 mg SC QW till Week 52. | ||
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End point title |
Percentage of Participants Who Achieved Disease Activity Score Based on 28 Joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at Week 24 [1] | ||||||||
End point description |
DAS28-ESR score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), patient global assessment of disease activity (PGA) (general health [GH]) using visual analog scale (VAS): 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in millimeters per hour [mm/hr]). The score is calculated using the following formula: DAS28-ESR = [0.56 multiplied by (*) square root (√) of TJC28] plus (+) [0.28*√SJC28]+[0.70*the natural logarithm (ln) ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score of less than (<) 2.6 represents DAS28-ESR remission. Full analysis set included all recruited participants who received at least one dose of SC tocilizumab. Number of subjects analyzed = participants evaluable for this endpoint.
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End point type |
Primary
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End point timeframe |
Week 24
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this endpoint |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Who Maintained DAS28-ESR Remission From Week 24 up to Week 52 Among Participants on Tocilizumab Monotherapy Since Week 24 | ||||||||||||||||||||||||
End point description |
DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = [0.56 * √TJC28 + [0.28*√SJC28]+[0.70*ln ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score <2.6 represents DAS28-ESR remission. Per protocol analysis. Number of subjects analyzed = participants evaluable for this endpoint. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Weeks 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Participants Who Achieved DAS28-ESR Remission/Low Disease Activity (LDA) From Week 28 up to Week 52 Among Participants With Intensification of Methotrexate/Other Non-Biologic DMARDs in Combination with Tocilizumab Since Week 24 | ||||||||||||||||||||||||||||||||||||
End point description |
DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = [0.56 * √TJC28 + [0.28*√SJC28]+[0.70*ln ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. DAS28-ESR score <2.6 represents DAS28-ESR remission. DAS28-ESR score greater than or equal to (>/=) 2.6 and <3.2 represents LDA. Full analysis set. Number of subjects analyzed = participants evaluable for this endpoint. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Weeks 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in DAS28-ESR up to Week 52 | ||||||||||||||||||||||||||||||||||||
End point description |
DAS28-ESR score is a measure of participant's disease activity calculated using TJC28, SJC28, PGA using VAS 0 mm=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (ESR in mm/hr) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28-ESR = [0.56 * √TJC28 + [0.28*√SJC28]+[0.70*ln ESR]+[0.014*GH]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity. A negative change from baseline indicates an improvement. Full analysis set. Number of subjects analyzed = participants evaluable for this endpoint. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Number of Participants With American College of Rheumatology 20 (ACR20) Response | ||||||||||||||||||||||||||||||||||
End point description |
ACR20 response was defined as >/=20% improvement from baseline in both TJC28 and SJC28 as well as in 3 out of 5 additional parameters: Separate patient and physician’s global assessment of disease activity on VAS (0 mm=no disease activity to 100 mm=maximum disease activity), patient’s assessment of pain on VAS (0 mm=no pain to 100 mm=unbearable pain), Health Assessment Questionnaire - Disability Index (HAQ-DI) (20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do), and acute phase response (ESR in mm/hr, for a total possible score of 0 to 10). Full analysis set. Number of subjects analyzed=participants evaluable for this endpoint. Here, n=number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Participants With Good, Moderate, or No Response According to European League Against Rheumatism (EULAR) Response Criteria | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Response to treatment was determined using EULAR criteria based upon DAS28 absolute scores at the assessment visit and the DAS28 reduction from the baseline visit. Participants with a score lesser than or equal to (</=) 3.2 and reduction of greater than (>) 1.2 points were assessed as having a 'good' response. Participants with a score >3.2 with reduction of >1.2 points, or a score </=5.1 with reduction of >0.6 to </=1.2 points, were assessed as having a 'moderate' response. Participants with a score >5.1 with reduction of >0.6 to </=1.2 points, or any score with reduction </=0.6 points, were assessed as having 'no response'. Full analysis set. Number of subjects analyzed = participants evaluable for this endpoint. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in Simplified Disease Activity Index (SDAI) Score up to Week 52 | ||||||||||||||||||||||||||||||||||||
End point description |
SDAI is an index for measuring disease activity. SDAI is the numerical sum of five outcome parameters: TJC28 and SJC28, PGA and physician global assessment of disease activity assessed on VAS (0 centimeter [cm]-10 cm); 0 cm= no disease activity and 10 cm= worst disease activity, and CRP (in milligrams per deciliter [mg/dL]). SDAI total score ranges from 0 to 86, with higher scores indicating increased (or severe) disease activity. SDAI score </=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. Full analysis set. Number of subjects analyzed = participants evaluable for this endpoint. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in TJC28 up to Week 52 | ||||||||||||||||||||||||||||||||||||
End point description |
28 joints were assessed for tenderness and joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 28. A negative change from baseline indicated improvement. Full analysis set. Number of subjects analyzed = participants evaluable for this endpoint. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in SJC28 up to Week 52 | ||||||||||||||||||||||||||||||||||||
End point description |
28 joints were assessed for swelling and joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 28. A negative change from baseline indicated improvement. Full analysis set. Number of subjects analyzed = participants evaluable for this endpoint. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Participants With Corticosteroid Dose Reduction or Discontinuation | ||||||||
End point description |
Full analysis set. Number of subjects analyzed = participants who used corticosteroids during the study.
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End point type |
Secondary
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End point timeframe |
From Baseline up to Week 52
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Participants by Reasons (Categories) for Corticosteroid Dose Reduction or Discontinuation | ||||||||||||
End point description |
Reasons for corticosteroid dose reduction included: Safety Reasons (including elevated liver function test results, respiratory infections, infections and infestations, gastrointestinal disorders etc.); Other Reasons (disease remission, improvement etc.); and Unknown Reasons (including no reason). Number of participants by reasons (Safety, Other, Unknown) for corticosteroid dose reduction or discontinuation were reported. Full analysis set. Number of subjects analyzed = participants with corticosteroid dose reduction/discontinuation.
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End point type |
Secondary
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End point timeframe |
From Baseline up to Week 52
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Number of Participants With Anti-Tocilizumab Antibodies (ATA) | ||||||||||||||||||||||||||||||||||||||||||
End point description |
All samples were tested using a screening assay and, if positive, by a confirmation assay to determine specificity and a neutralizing assay to test for the ability to inhibit the activity of tocilizumab. Number of participants with a positive assay result for screening assay (ATA - Screen), confirmatory assay (ATA - Confirmatory), and neutralizing assay (ATA - Neutralizing) was reported separately. Full analysis set. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||
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End point title |
Soluble Interleukin-6 Receptor (sIL-6R) Levels | ||||||||||||||||||||
End point description |
Full analysis set. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
Tocilizumab Serum Levels | ||||||||||||||||||||
End point description |
Full analysis set. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 12, 24, 36, 52, and 8 weeks after Week 52 dose (Week 60)
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| No statistical analyses for this end point | |||||||||||||||||||||
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End point title |
PGA, Using VAS Score | ||||||||||||||||||||||||||||||||||||||
End point description |
PGA was assessed on a 0 to 100 mm horizontal VAS. The extreme left end of the line = 0 mm, and was described as "no disease activity" (symptom-free and no arthritis symptoms) and the extreme right end = 100 mm, and was described as "maximum disease activity" (maximum arthritis disease activity). Higher values correspond to worst state of participant (high disease activity). Full analysis set. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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End point title |
Patient Assessment of Pain, Using VAS Score | ||||||||||||||||||||||||||||||||||||||
End point description |
The participant's level of pain was assessed on a 0 to 100 mm horizontal VAS. The extreme left end of the line = 0 mm, and was described as "no pain" and the extreme right end = 100 mm, and was described as "unbearable pain". Higher values correspond to worst state of participant (higher level of pain). Full analysis set. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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End point title |
HAQ-DI Score | ||||||||||||||||||||||||||||||||||||||
End point description |
The Stanford HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 component sets: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Responses in each component set were scored from 0 (without any difficulty) to 3 (unable to do). The highest score recorded for any question in a category determines the score for the category, unless aids, devices, or help from another person was required. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, giving a possible range of scores from 0 to 3. Scores of 0 to 1 are generally considered to represent "mild to moderate difficulty", 1 to 2 as "moderate to severe disability", and 2 to 3 as "severe to very severe disability". Full analysis set. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Participants Who Received All Planned Study Medication (Compliance) | ||||||||||||||||||||||||||||||||||||||
End point description |
Compliance (in terms of percentage of participants who received all planned study medication) was assessed on the basis of participant diary cards and return records. Full analysis set. Here, n = number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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End point title |
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Total Score | ||||||||||||||||||||||||||||||||||||||
End point description |
FACIT-Fatigue (FACIT-F) total score is sum of FACIT-General (FACIT-G) subscale score and FACIT-F subscale score. FACIT-G consists of 27 questions grouped in 4 domains of general health-related quality of life: physical, social/family, emotional, and functional well-being; each item ranges from 0 (not at all) to 4(very much). FACIT-G score ranges between 0-108. FACIT-F subscale is 13-item questionnaire that evaluates self-reported fatigue and its impact upon daily activities. Each item ranges from 0(Not at all) to 4 (Very much). For all items, except for 2 negatively stated ones, code was reversed and new score was calculated as 4 minus participant's response. Sum of all responses resulted in FACIT-F subscale score for total possible score of 0(worse score) to 52(better score). FACIT-F total score (FACIT-G plus FACIT-F subscale scores) ranges from 0 (better score) to 160 (worse score). Full analysis set. Here, n=number of participants analyzed for this endpoint at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline (Week 1), Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
From Baseline up to end of study (Week 60)
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Adverse event reporting additional description |
Safety population included all participants who received at least one dose of SC tocilizumab. Adverse events were reported separately for the participants who received tocilizumab monotherapy and tocilizumab in combination with methotrexate or other non-biologic DMARDs.
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.1
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Reporting groups
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Reporting group title |
Tocilizumab + Methotrexate or Other Non-Biologic DMARDs
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Reporting group description |
Participants received tocilizumab 162 mg SC injection QW in combination with methotrexate or other non-biologic DMARDs during the treatment period of 52 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Tocilizumab Monotherapy
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Reporting group description |
Participants received tocilizumab 162 mg SC injection QW as monotherapy during the treatment period of 52 weeks. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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14 Oct 2014 |
Protocol ML28695 had been amended in order to provide participants the investigational medicinal product (IMP) until it becomes commercially available and reimbursed in Greek market. Additional changes to the protocol were as follows:
• Participants who completed 60 weeks in the study before tocilizumab SC became commercially available and reimbursed, would enter an extension phase until the IMP became commercially available and reimbursed in the Greek market.
• Efficacy and Safety outcome measures would continue to be collected/ monitored according to the revised schedule of assessments. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
