Clinical Trial Results:
Short-term efficacy of a single ultrasound-guided intra-articular injection of botulinum toxin A associated with splinting for base-of-thumb osteoarthritis on pain at 3 months: A randomized placebo-controlled pilot study
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Summary
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EudraCT number |
2016-003939-38 |
Trial protocol |
FR |
Global end of trial date |
23 Apr 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Jun 2022
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First version publication date |
19 Jun 2022
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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 |
P160404J
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03187626 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
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Sponsor organisation address |
DRCI Hôpital Saint-Louis, 1 avenue Claude Vellefaux, PARIS, France, 75010
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Public contact |
DRCI Hôpital St Louis, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP), josephine.braun@aphp.fr
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Scientific contact |
AP-HP Hôpital Cochin, ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP), christelle.nguyen2@aphp.fr
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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 |
12 Apr 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
23 Apr 2021
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Apr 2021
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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 compare the efficacy on pain at 3 months of a single ultrasound-guided intra-articular injection of (botulinum toxin A) BTA associated with splinting to a single ultrasound-guided intra-articular injection of saline associated with splinting in patients with painful Base-of-thumb osteoarthritis (BTOA)
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Protection of trial subjects |
Patients benefit from specific medical monitoring and the single trapezio-metacarpal intra-articular infiltration, i.e. at the base of the thumb, is performed under ultrasound by an experienced radiologist.
AP-HP has taken all measures to conduct this research in accordance with the provisions of the Public Health Code applicable to research involving humans.
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Background therapy |
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Evidence for comparator |
- | ||
Actual start date of recruitment |
29 Nov 2018
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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 |
France: 60
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Worldwide total number of subjects |
60
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EEA total number of subjects |
60
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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) |
34
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From 65 to 84 years |
24
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85 years and over |
2
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Recruitment
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Recruitment details |
Participants to be recruited among patients seen in hospital consultation and rehabilitation hospitalization at Cochin Hospital and presenting with rhizarthrosis as well as among the patients of the DIGICODE digital osteoarthritis cohort (Hôpital Saint-Antoine) and the employees of the AP-HP via the intranet and the AP mailing list -HP | |||||||||
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Pre-assignment
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Screening details |
Participants will be recruited from outpatients and those seen in hospital consultations, occupational therapy consultations, or full or partial hospitalization in physical medicine and rehabilitation (PMR) at Hôpital Cochin with rhizarthrosis | |||||||||
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Period 1
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Period 1 title |
overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Subject, Investigator | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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botulinum toxin | |||||||||
Arm description |
Experimental | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
toxine botulinique de type A
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intraarticular use
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Dosage and administration details |
50 units, administered in a single intra-articular, trapezoidal-metacarpal, ultrasound-guided injection performed by an experienced radiologist
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Arm title
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Placebo | |||||||||
Arm description |
Placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
saline
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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 |
Intraarticular use
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Dosage and administration details |
1 ml NaCl 0,9%, administered in a single intra-articular, trapezoidal-metacarpal, ultrasound-guided injection performed by an experienced radiologist
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Baseline characteristics reporting groups
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Reporting group title |
botulinum toxin
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Reporting group description |
Experimental | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
botulinum toxin
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Reporting group description |
Experimental | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo | ||
Subject analysis set title |
intent to treat
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
intent to treat
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End point title |
Change in base of thumb pain score at 3 monts | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
3 months
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Statistical analysis title |
Statistical analysis | ||||||||||||
Comparison groups |
botulinum toxin v Placebo
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Number of subjects included in analysis |
60
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 [1] | ||||||||||||
Method |
Constrained longitudinal data analysis | ||||||||||||
Confidence interval |
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| Notes [1] - p<0.05 Constrained longitudinal data analysis Chi-squared test Fisher's exact test |
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Adverse events information
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Timeframe for reporting adverse events |
6 months
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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 |
24
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Reporting groups
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Reporting group title |
experimental
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Reporting group description |
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Reporting group title |
placebo
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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02 Mar 2018 |
Modification of the data collection at 1 month in the protocol and in the information note: patients will complete the information concerning health status and medication consumption and the pain scale at the +1 month visit |
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26 Jun 2018 |
- clarification of non-inclusion criteria to "Neurological conditions affecting the hand other than carpal tunnel syndrome" and "Osteoarthritis predominating at the scaphotrapezial joint on radiographs
- Modification of the practical conduct of the study by grouping the inclusion visit and the infiltration visit on the same day
- Correction of the type of orthesis used: The ortheses usually used for rhizarthrosis are thermoformed plastic ortheses
- Modification of the practical procedure by adding the collection of AEs at M1 at the request of the ANSM
- Addition of the self-questionnaire for the collection of adverse events |
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28 May 2019 |
- 6-month extension of the duration of inclusions
- Compliance of the paragraphs relating to the processing of health data with the legislative and regulatory framework of the GDPR
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07 Feb 2020 |
- 6-month extension of the duration of inclusions
- Addition of a non-inclusion criterion: "Patient with epilepsy": in accordance with the product's SmPC
- Addition of the credibility questionnaire to the follow-up at 6 months |
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28 Jul 2020 |
6-month extension of the duration of inclusions |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? Yes | |||||||
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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 | |||||||
