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Clinical Trial Results:
Effects on pain of infiltration by a combination of hyaluronic acid and corticoids versus corticoids alone in rhizarthrosis.

Summary
EudraCT number	2017-002298-20
Trial protocol	FR
Global end of trial date	16 Dec 2021

Results information
Results version number	v1(current)
This version publication date	30 Jun 2023
First version publication date	30 Jun 2023
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CHD046-17

ISRCTN number

US NCT number

NCT03431584

WHO universal trial number (UTN)

Sponsor organisation name

Centre Hospitalier Départemental Vendée

Sponsor organisation address

Boulevard Stéphane Moreau , La Roche-sur-Yon, France, 85000

Public contact

Dr Grégoire CORMIER , Centre Hospitalier Départemental Vendée, promotion.urc@chd-vendee.fr

Scientific contact

Dr Grégoire CORMIER , Centre Hospitalier Départemental Vendée, promotion.urc@chd-vendee.fr

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

31 May 2022

Is this the analysis of the primary completion data?

Yes

Primary completion date

22 Mar 2021

Global end of trial reached?

Yes

Global end of trial date

16 Dec 2021

Was the trial ended prematurely?

Main objective of the trial

To compare the efficacy of the association hyaluronic acid+steroids versus saline+steroids in patients with painful rhizarthrosis despite medical therapy.

Protection of trial subjects

All adverse events or reactions (except tjose specified in the protocol), wether expected or unexpected, seriou or not, were collected in the eCRF. The follow-up of serious events or adverse reaction was ensured until resolution or consolidation.

Background therapy

Evidence for comparator

Actual start date of recruitment

11 May 2018

Long term follow-up planned

Yes

Long term follow-up rationale

Efficacy

Long term follow-up duration

3 Months

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

France: 150

Worldwide total number of subjects

150

EEA total number of subjects

150

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

254 patients were screened for inclusion 150 patient signed an informed consent and were randomised but 1 patient lost to follow-up after infiltration

Screening details

254 patients were screened

Period 1 title

Overall trial (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Blinding implementation details

Patient "blinding" was ensure with the placement of a sterile field, vertically on an infusion stand before injection by the physician

Are arms mutually exclusive

Yes

betamethasone and hyaluronic acid

Arm description

0.5 ml of CTC (betamethasone ) and 0.5 ml of HA (hyaluronic acid )

Arm type

Experimental

Investigational medicinal product name

Betamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intraarticular use

Dosage and administration details

0.5 mL (7 mg/mL)

Investigational medicinal product name

Hyaluronic acid

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intraarterial use

Dosage and administration details

0.5mL (8mg/ mL)

betamethasone and saline

Arm description

0.5 ml of CTC (betamethasone ) and 0.5 ml of saline

Arm type

Active comparator

Investigational medicinal product name

Betamethasone

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

0.5 mL (7 mg/ mL)

Investigational medicinal product name

Saline

Investigational medicinal product code

Other name

Pharmaceutical forms

Solvent for...

Routes of administration

Intraarticular use

Dosage and administration details

0.5 mL (NaCL 0.9%)

Number of subjects in period 1 ^[1]	betamethasone and hyaluronic acid	betamethasone and saline
Started	73	76
M1 - intermediate visit	73	76
M3 - intermediate visit	73	73
M6 - intermediate visit	72	71
M12 - End of study	65	69
Completed	65	69
Not completed	8	7
Adverse event, serious fatal	-	1
Physician decision	1	-
Consent withdrawn by subject	1	4
visit canceled	3	1
Lost to follow-up	3	1

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: One patient in the "betamethasone & hyaluronic acid" group was lost to follow-up after infiltration. 149 patients were included for analysis

Baseline characteristics

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Reporting group title

betamethasone and hyaluronic acid

Reporting group description

0.5 ml of CTC (betamethasone ) and 0.5 ml of HA (hyaluronic acid )

Reporting group title

betamethasone and saline

Reporting group description

0.5 ml of CTC (betamethasone ) and 0.5 ml of saline

Reporting group values	betamethasone and hyaluronic acid	betamethasone and saline	Total
Number of subjects	73	76	149
Age categorical
Units: Subjects
In utero	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0
Newborns (0-27 days)	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0
Children (2-11 years)	0	0	0
Adolescents (12-17 years)	0	0	0
Adults (18-64 years)	44	41	85
From 65-84 years	29	35	64
85 years and over	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	61.8 ( 9.3 )	61.9 ( 8.9 )	-
Gender categorical
Units: Subjects
Female	61	62	123
Male	12	14	26

End points

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Reporting group title

betamethasone and hyaluronic acid

Reporting group description

0.5 ml of CTC (betamethasone ) and 0.5 ml of HA (hyaluronic acid )

Reporting group title

betamethasone and saline

Reporting group description

0.5 ml of CTC (betamethasone ) and 0.5 ml of saline

Primary: effectiveness of thumb infiltration

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End point title

effectiveness of thumb infiltration

End point description

The endpoint was the intensity of pain at the base of the thumb during activity at 3 months. This evaluation was done by asking the following question: "During the last week, how would you estimate the average intensity of pain caused by osteoarthritis of your thumb during activity?" in order to have a standardization of its collection.

End point type

Primary

End point timeframe

End point values	betamethasone and hyaluronic acid	betamethasone and saline
Number of subjects analysed	73	73
Units: centimeter
least squares mean (confidence interval 95%)	-2.65 (-3.29 to -2.01)	-1.66 (-2.29 to -1.03)

effectiveness of thumb infiltration

Comparison groups

betamethasone and hyaluronic acid v betamethasone and saline

Number of subjects included in analysis

146

Analysis specification

Pre-specified

Analysis type

superiority

P-value

≤ 0.05

Method

Mixed models analysis

Confidence interval

Adverse events

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Timeframe for reporting adverse events

From randomisation (intervention) until end of participation of patient (M12)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

betamethasone and hyaluronic acid

Reporting group description

0.5 ml of CTC (betamethasone ) and 0.5 ml of HA (hyaluronic acid )

Reporting group title

betamethasone and saline

Reporting group description

0.5 ml of CTC (betamethasone ) and 0.5 ml of saline

Serious adverse events	betamethasone and hyaluronic acid	betamethasone and saline
Total subjects affected by serious adverse events
subjects affected / exposed	11 / 73 (15.07%)	16 / 76 (21.05%)
number of deaths (all causes)	0	1
number of deaths resulting from adverse events	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 1
OVARIAN CANCER
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
PYOGENIC GRANULOMA
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Injury, poisoning and procedural complications
PELVIC FRACTURE
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TOXICITY TO VARIOUS AGENTS
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Vascular disorders
DEEP VEIN THROMBOSIS
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Surgical and medical procedures
JOINT ARTHROPLASTY
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
TRAPEZIECTOMY
subjects affected / exposed	0 / 73 (0.00%)	2 / 76 (2.63%)
occurrences causally related to treatment / all	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
Nervous system disorders
CARPAL TUNNEL SYNDROME
subjects affected / exposed	2 / 73 (2.74%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0
General disorders and administration site conditions
PYREXIA
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Eye disorders
CATARACT
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Gastrointestinal disorders
PANCREATITIS
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
Psychiatric disorders
ALCOHOL ABUSE
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0
OSTEOARTHRITIS
subjects affected / exposed	2 / 73 (2.74%)	5 / 76 (6.58%)
occurrences causally related to treatment / all	0 / 2	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0
PAIN IN EXTREMITY
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
ROTATOR CUFF SYNDROME
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0
TENOSYNOVITIS STENOSANS
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences causally related to treatment / all	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	betamethasone and hyaluronic acid	betamethasone and saline
Total subjects affected by non serious adverse events
subjects affected / exposed	16 / 73 (21.92%)	21 / 76 (27.63%)
Nervous system disorders
MIGRAINE
subjects affected / exposed	3 / 73 (4.11%)	0 / 76 (0.00%)
occurrences all number	3	0
SCIATICA
subjects affected / exposed	1 / 73 (1.37%)	0 / 76 (0.00%)
occurrences all number	1	0
General disorders and administration site conditions
PERIPHERAL SWELLING
subjects affected / exposed	1 / 73 (1.37%)	1 / 76 (1.32%)
occurrences all number	1	1
MALAISE
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences all number	0	1
INJECTION SITE HAEMATOMA
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences all number	0	1
INJECTION SITE ATROPHY
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences all number	0	1
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	2 / 73 (2.74%)	1 / 76 (1.32%)
occurrences all number	2	1
BACK PAIN
subjects affected / exposed	0 / 73 (0.00%)	2 / 76 (2.63%)
occurrences all number	0	2
MUSCULOSKELETAL PAIN
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences all number	0	1
PAIN IN EXTREMITY
subjects affected / exposed	10 / 73 (13.70%)	13 / 76 (17.11%)
occurrences all number	11	14
TENDON DISORDER
subjects affected / exposed	0 / 73 (0.00%)	1 / 76 (1.32%)
occurrences all number	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

27 Mar 2018

clarification of treatment kit labeling

11 Nov 2018

treatment kits will no longer be dispensed by the pharmacy but will be available in the services

12 Nov 2019

extended inclusion period (additional 18 months)

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results:
Effects on pain of infiltration by a combination of hyaluronic acid and corticoids versus corticoids alone in rhizarthrosis.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: effectiveness of thumb infiltration

Primary: effectiveness of thumb infiltration

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

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Clinical trials

Clinical Trial Results: Effects on pain of infiltration by a combination of hyaluronic acid and corticoids versus corticoids alone in rhizarthrosis.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: effectiveness of thumb infiltration

Primary: effectiveness of thumb infiltration

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Effects on pain of infiltration by a combination of hyaluronic acid and corticoids versus corticoids alone in rhizarthrosis.