Clinical Trial Results:
Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs – OSCAR
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Summary
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EudraCT number |
2013-000342-19 |
Trial protocol |
NL |
Global end of trial date |
26 May 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
04 Jun 2017
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First version publication date |
04 Jun 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 |
ML28702
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01987479 | ||
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 Oct 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 |
26 May 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 |
This multi-center, open-label single arm Phase IIIb study evaluated the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic DMARDs.
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Protection of trial subjects |
This 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 afforded the greater protection to the individual.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Jan 2014
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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 |
Netherlands: 150
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Worldwide total number of subjects |
150
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EEA total number of subjects |
150
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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) |
122
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From 65 to 84 years |
27
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85 years and over |
1
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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 174 participants were screened, out of which 150 participants met eligibility criteria and were enrolled into the study. | ||||||||||||||||||||
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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 Alone or in Combination with Methotrexate or DMARD | ||||||||||||||||||||
Arm description |
Participants received a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. | ||||||||||||||||||||
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 |
Tocilizumab 162 mg was administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 24 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Tocilizumab Alone or in Combination with Methotrexate or DMARD
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Reporting group description |
Participants received a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. | |||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Tocilizumab Alone or in Combination with Methotrexate or DMARD
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Reporting group description |
Participants received a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks. | ||
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End point title |
Percentage of Participants With Adverse Events [1] | ||||||||
End point description |
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Adverse events included serious as well as non-serious adverse events. Full Analysis Set (FAS) population included all participants who received at least one dose of SC tocilizumab.
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End point type |
Primary
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End point timeframe |
Baseline up to Week 32
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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 statistical analyses were planned for this endpoint but descriptive statistics only |
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| No statistical analyses for this end point | |||||||||
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End point title |
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal | ||||||||||||||||||||||||||
End point description |
DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR; millimeters per hour [mm/hour]), and patient’s global assessment of disease activity (measured on a 0 to 100 mm Visual Analog Scale [VAS] where 0 mm=no disease activity and 100 mm=worst disease activity). DAS28 scores were calculated as [0.56 × square root of TJC] + [0.28 × square root of SJC] + [0.70 × natural log (ESR)] + [0.014 × VAS]. Total score range: 0-10, higher score=higher disease activity. DAS28-ESR less than or equal to (≤) 3.2 implied low disease activity and greater than (>) 3.2 to 5.1 implied moderate to high disease activity, and DAS28-ESR less than (<) 2.6 implied clinical remission. FAS population. Here, “n” = participants who were evaluable at the specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Percentage of Participants Achieving an American College of Rheumatology Criteria 20 (ACR20) Response | ||||||||||||||||||||||||
End point description |
A participant had an ACR20 response if there was at least a 20 percent (%) improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either C-reactive protein [CRP] or ESR). FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Participants Achieving an ACR50 Response | ||||||||||||||||||||||||
End point description |
A participant had an ACR50 response if there was at least a 50% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Participants Achieving an ACR70 Response | ||||||||||||||||||||||||
End point description |
A participant had an ACR70 response if there was at least a 70% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Participants Achieving an ACR90 Response | ||||||||||||||||||||||||
End point description |
A participant had an ACR90 response if there was at least a 90% improvement, ie, reduction from Baseline, in TJC and SJC (28 assessed joints) and in at least 3 of the following 5 parameters: 1) Physician's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 2) Patient's Global Assessment of Disease Activity [VAS: 0 mm=no disease activity to 100 mm=maximum disease activity]; 3) Patient's Assessment of Pain [VAS: 0 mm=no pain to 100 mm=unbearable pain]; 4) Health Assessment Questionnaire [20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do] and 5) an acute-phase reactant (either CRP or ESR). FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Participants With European League Against Rheumatism (EULAR) Response (Good, Moderate or No Response) Based on DAS28-ESR | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
DAS28-ESR was calculated from SJC and TJC using 28 joints count, ESR (mm/hour), and patient's global assessment of disease activity (VAS: 0 mm=no disease activity to 100 mm=maximum disease activity). DAS28-ESR=[0.56×square root of TJC]+[0.28× square root of SJC]+[0.70×natural log (ESR)]+[0.014×VAS]. DAS28-ESR based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and level of disease activity reached. Good responders had a change from baseline >1.2 with a DAS28 score ≤3.2; moderate responders had a change from baseline >1.2 with a DAS28 score >3.2 or a change from baseline >0.6 to ≤1.2 with a DAS28 score ≤5.1. Participants with change from baseline >0.6 to ≤1.2 with a DAS28 score >5.1, or any score with change from baseline ≤0.6, were assessed as non-responders. FAS population. “n”=participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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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) at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal | ||||||||||||||||||||||||||
End point description |
The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease The SDAI is the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician global assessment of disease activity assessed on 0-10 centimeter (cm) VAS (0 cm= no disease activity and 10 cm= worst disease activity), and CRP in milligrams per liter (mg/L). SDAI total score = 0-86. SDAI <=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. FAS population. Here, “Number of subjects analysed” = participants who were evaluable for this outcome. “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 8, 16, 20, 24, and Early Withdrawal | ||||||||||||||||||||||||||
End point description |
The CDAI is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, patient and physician’s global assessment of disease activity assessed on 0-10 cm VAS (0 cm= no disease activity and 10 cm= worst disease activity). CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity. FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Change From Baseline in Total TJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of tender joints was determined by examining 28 joints for TJC28 and 68 joints for TJC68, and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1; total was calculated by adding all the joints for a maximum score of 28 for a TJC28 and 68 for a TJC68. A reduction in number of tender joints compared to baseline indicates improvement. FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Change From Baseline in Total SJC at Weeks 2, 4, 8, 12, 16, 20, 24, and Early Withdrawal | ||||||||||||||||||||||||||||||||||||||||||||
End point description |
Number of swollen joints was determined by examination of 28 joints for SJC28 and 66 joints for SJC66 and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1; total was calculated by adding all the joints for a maximum score of 28 for a SJC28 and 66 for a SJC66. A reduction in number of swollen joints compared to baseline indicates improvement. FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and at Early Withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of Participants With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Dose Reductions or Discontinuation Categorized by Reasons | ||||||||||||||||||||||||||||
End point description |
Results are reported for percentage of participants who had NSAIDs dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort). FAS population
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End point type |
Secondary
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End point timeframe |
From Week 16 and before Week 20; From Week 20 and before Week 24
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Percentage of Participants With Corticosteroid Dose Reductions or Discontinuation Categorized by Reasons | ||||||||||||||||||||||||||||
End point description |
Results are reported for percentage of participants who had corticosteroid dose reductions or discontinuation by reasons for dose reductions or discontinuation (unknown reasons, safety reasons, other reasons, lack of efficacy, and discomfort). FAS population
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End point type |
Secondary
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End point timeframe |
From Week 16 and before Week 20; From Week 20 and before Week 24
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
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End point title |
Time to Discontinuation or First Dose Reduction of Corticosteroids or NSAIDs | ||||||||
End point description |
Time to discontinuation or first dose reduction of corticosteroids or NSAIDs (weeks) = (Date of the first dose reduction or end date of corticosteroids or NSAIDs treatment - date of first drug intake of this study) + 1. FAS population. Time to discontinuation or first dose reduction was based on first occurring event (corticosteroid discontinuation or corticosteroid first dose reduction or NSAIDs discontinuation or NSAIDs first dose reduction, whichever occurred first).
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End point type |
Secondary
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End point timeframe |
Baseline up to Week 32
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| No statistical analyses for this end point | |||||||||
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End point title |
Serum Levels of Tocilizumab | ||||||||||||||||||
End point description |
FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Serum Levels of Soluble Interleukin-6 Receptors (sIL-6Rs) | ||||||||||||||||||
End point description |
FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 12 and 24, Early Withdrawal (up to Week 24), Follow-up Visit (8 weeks after last dose of tocilizumab, up to 32 weeks)
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Patient Global Assessment of Disease Activity VAS Scores | ||||||||||||||||||||||||||
End point description |
Patient global assessment of disease activity was measured on a 0 to 100 mm horizontal VAS where 0 mm=no disease activity and 100 mm=maximum disease activity. FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Patient Pain VAS Scores | ||||||||||||||||||||||||||
End point description |
This assessment represents the participant’s assessment of his/her current level of pain on a 100 mm horizontal VAS where 0 mm = no pain to 100 mm = unbearable pain. FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and Early withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score | ||||||||||||||||||||||||||
End point description |
The HAQ-DI questionnaire measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI was the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do. FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Percentage of Participants Compliant to Tocilizumab Treatment as Measured by Diary Cards and Return Records | ||||||||||||||||||||||||
End point description |
A diary card was provided to participants to record home injections. Participants were asked to return all empty drug supply boxes, unused pre-filled syringe, and diary cards to the clinic at each visit as a measure of drug accountability and participant compliance. A participant was considered compliant if the participant correctly administered all scheduled doses of SC tocilizumab during the assessment period. FAS population. Here, “n” = participants who were evaluable 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, and early withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score | ||||||||||||||||||||||||||
End point description |
The FACIT-F score was calculated according to a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function. FACIT-F is a 13-item questionnaire. Participants scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the participants fatigue. For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as (4 minus the participant's response). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score). FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 2, 4, 8, 12, 16, 20, 24, and early withdrawal (up to Week 24)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||
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End point title |
Percentage of Participants With Anti-Tocilizumab Antibodies | ||||||||||||||||||
End point description |
FAS population. Here, “n” = participants who were evaluable at specified timepoint.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 12 and 24, early withdrawal (up to Week 24), follow-up visit (8 weeks after last dose of tocilizumab, up to 32 weeks)
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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 |
Baseline up to Week 32
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Adverse event reporting additional description |
FAS population
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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 |
19.0
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Reporting groups
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Reporting group title |
Tocilizumab Alone or in Combination with Methotrexate or DMARD
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Reporting group description |
Participants received a weekly SC injection of tocilizumab 162 mg as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 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? No | |||
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 | |||
