Clinical Trial Results:
An Open-Label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
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Summary
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EudraCT number |
2013-002790-22 |
Trial protocol |
HU CZ EE |
Global end of trial date |
26 May 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Jun 2016
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First version publication date |
09 Jun 2016
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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 |
EFC13752
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02121210 | ||
WHO universal trial number (UTN) |
U1111-1143-4344 | ||
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Sponsors
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Sponsor organisation name |
Sanofi aventis recherche & développement
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Sponsor organisation address |
1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
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Public contact |
Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
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Scientific contact |
Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.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 |
01 Jun 2015
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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 2015
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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 |
To evaluate the immunogenicity of sarilumab administered as monotherapy from baseline to Week 24.
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Protection of trial subjects |
Subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency.
Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Jun 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 |
Poland: 17
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Country: Number of subjects enrolled |
Czech Republic: 14
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Country: Number of subjects enrolled |
Estonia: 13
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Country: Number of subjects enrolled |
Hungary: 18
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Country: Number of subjects enrolled |
Chile: 8
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Country: Number of subjects enrolled |
Russian Federation: 24
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Country: Number of subjects enrolled |
United States: 38
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Worldwide total number of subjects |
132
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EEA total number of subjects |
62
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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) |
105
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From 65 to 84 years |
27
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted at 27 centres in 7 countries. A total of 201 subjects were screened between 03 June 2014 and 20 October 2014. | |||||||||||||||||||||
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Pre-assignment
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Screening details |
Of 201 subjects, 69 subjects were screen failures due to exclusion criteria met and inclusion criteria not met. 132 subjects were randomized in 1:1 ratio to either sarilumab 150 mg every two weeks (q2w) or sarilumab 200 mg q2w. | |||||||||||||||||||||
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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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Are arms mutually exclusive |
Yes
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Arm title
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Sarilumab 150 mg q2w | |||||||||||||||||||||
Arm description |
Sarilumab 150 mg q2w for 24 weeks. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Sarilumab
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Investigational medicinal product code |
SAR153191 (REGN88)
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subcutaneous injection in the abdomen, thigh or upper arm.
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Arm title
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Sarilumab 200 mg q2w | |||||||||||||||||||||
Arm description |
Sarilumab 200 mg q2w for 24 weeks. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Sarilumab
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Investigational medicinal product code |
SAR153191 (REGN88)
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subcutaneous injection in the abdomen, thigh or upper arm.
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Baseline characteristics reporting groups
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Reporting group title |
Sarilumab 150 mg q2w
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Reporting group description |
Sarilumab 150 mg q2w for 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sarilumab 200 mg q2w
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Reporting group description |
Sarilumab 200 mg q2w for 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Sarilumab 150 mg q2w
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Reporting group description |
Sarilumab 150 mg q2w for 24 weeks. | ||
Reporting group title |
Sarilumab 200 mg q2w
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Reporting group description |
Sarilumab 200 mg q2w for 24 weeks. | ||
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End point title |
Percentage of Subjects With Incidence of Antidrug Antibodies (ADA) [1] | |||||||||||||||||||||
End point description |
ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of subjects with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product [IMP] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30. Analysis was performed on immunogenicity population included all randomized subjects who received at least one dose of sarilumab with at least one post-dose, evaluable ADA sample.
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End point type |
Primary
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End point timeframe |
From Baseline to Week 30 [End of study (EOS)]
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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: Only descriptive statistics are provided for this endpoint. |
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Serum Sarilumab Concentration | ||||||||||||
End point description |
Trough concentration (Ctrough). Analysis was performed on pharmacokinetics (PK) population consisted of all randomized population actually received at least one or partial dose of IMP, with at least one post-dose, non-missing serum sarilumab concentration. Number of subjects analyzed=subjects with serum sarilumab concentration assessment at specified time-points.
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End point type |
Secondary
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End point timeframe |
Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30
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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 |
All adverse events (AEs) were collected from signature of the informed consent form up to the final visit (Week 30) regardless of seriousness or relationship to investigational product.
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Adverse event reporting additional description |
Reported adverse events are treatment emergent adverse events that is AEs that developed/worsened during the time from the first dose of IMP to last dose of IMP + 60 days.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
Sarilumab 150 mg q2w
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Reporting group description |
Sarilumab 150 mg q2w for 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Sarilumab 200 mg q2w
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Reporting group description |
Sarilumab 200 mg q2w 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 | |||
