Clinical Trial Results:
The role of inflammatory biomarkers in pathophysiology of cardiovascular dysfunction in systemic inflammatory conditions- Part II
Summary
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EudraCT number |
2007-005464-26 |
Trial protocol |
GB |
Global end of trial date |
30 Apr 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Apr 2019
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First version publication date |
26 Apr 2019
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Other versions |
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Summary report(s) |
FINAL STUDY REPORT |
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 |
RECrefno07/H0707/114
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
King's College London
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Sponsor organisation address |
The Strand, London, United Kingdom, WC2R 2LS
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Public contact |
Dr Valentina Puntmann, Kings College London, 0044 0207188 7242, v.puntmann@kcl.ac.uk
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Scientific contact |
Dr Valentina Puntmann, Kings College London, 0044 0207188 7242, v.puntmann@kcl.ac.uk
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Sponsor organisation name |
Guy's and St Thomas' NHS Foundation Trust
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Sponsor organisation address |
Great Maze Pond, London, United Kingdom, SE19RT
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Public contact |
Dr Valentina Puntmann, Guy's and St Thomas' NHS Foundation Trust, 0044 0207188 7242, v.puntmann@kcl.ac.uk
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Scientific contact |
Dr Valentina Puntmann, Guy's and St Thomas' NHS Foundation Trust, 0044 0207188 7242, v.puntmann@kcl.ac.uk
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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 |
30 Apr 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Apr 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Apr 2014
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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 investigate TNF-alpha inhibitors altering cardiovascular function in patients with systemic inflammatory conditions (FMD, LV mass/LV volumes)
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Protection of trial subjects |
Patients will be recruited from the respective speciality clinics (rheumatology, gastroenterology), only after clinical diagnoses have been established and the clinical decision on eligibility for anti-TNF therapy has been reached independently by the clinical team in
charge of the patient. Clinical decision making will be in line with the recommendations of the NICE guidelines and eligibility specifications outlined in SmPCs of the respective anti-TNF therapies (infliximab, etanercept and adalimumab). This also includes the concomitant
medication, such as the use of methotrexate in patients with rheumatoid arthritis.
Only adult patients were recruited. Women of childbearing potential needed to provide a negative pregnancy test prior to study entry.
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Background therapy |
- | ||
Evidence for comparator |
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Actual start date of recruitment |
01 Aug 2008
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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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 |
United Kingdom: 14
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Worldwide total number of subjects |
14
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EEA total number of subjects |
14
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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) |
14
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Patients will be recruited from the speciality clinics (rheumatology), only after clinical diagnoses have been established and the clinical decision on eligibility for anti-TNF therapy has been reached independently by the clinical team in charge of the patient. | |||||||||
Pre-assignment
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Screening details |
Inclusion criteria in clinical trial: Male and female subjects over 18 years of age. Systemic inflammatory conditions (Rheumatoid arthritis) - diagnosis established independently by the clinical team Eligibility for anti-TNF-α therapy – decision to start treatment will be reached independently by the clinical team. | |||||||||
Period 1
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Period 1 title |
Overall Trial Period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Remicade | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Remicade
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for concentrate for solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Total 3mg/Kg
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Arm title
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Enbrel | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Enbrel
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Investigational medicinal product code |
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Other name |
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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 |
50 mg milligram(s)
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Baseline characteristics reporting groups
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Reporting group title |
Remicade
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
Reporting group title |
Enbrel
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Remicade
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Reporting group description |
- | ||
Reporting group title |
Enbrel
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Reporting group description |
- |
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End point title |
Primary Endpoint [1] | |||||||||
End point description |
1. Aortic distensibility and stiffness studies (PWV and AD)
2. Myocardial function (LV mass, LV volumes)
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End point type |
Primary
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End point timeframe |
From baseline to 18 months post initiation of anti-TNF therapy
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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: Please see final study report |
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Attachments |
Trial results |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From consent to 18 months after anti-TNF therapy was initiated.
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Assessment type |
Systematic | |||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
17.1
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Reporting groups
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Reporting group title |
Remicade
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Reporting group description |
- | |||||||||||||||
Reporting group title |
Enbrel
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Reporting group description |
- | |||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
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Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No AEs were reported during the trial |
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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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01 Oct 2009 |
Amendment made when study was being conducted by previous sponsor. |
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15 Mar 2012 |
Change of sponsor from Imperial to King's College London and Guy's and St. Thomas' NHS Foundation Trust |
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24 May 2012 |
The addition of IMP Certolizumab pegol (Cimzia) as this has become the first line agent in treating rheumatoid patients at St. Thomas’ Hospital.
Addition of “demyelinating disease” to the listed exclusion criteria, this is listed as a precaution for use in the Cimzia SmPC dated 14/01/2013.
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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 |