Clinical trial • Phase III • Musculoskeletal

Botulinum toxin type A for Trapeziometacarpal osteoarthritis | Rhizarthrosis

Phase III trial of Botulinum toxin type A for Trapeziometacarpal osteoarthritis | Rhizarthrosis.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Trapeziometacarpal osteoarthritis | Rhizarthrosis
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme | Small molecule

Key dates

Initial CTIS Submission Date
07-10-2024
First CTIS Authorization Date
24-01-2025

Trial design

Randomised, sodium chloride (normal saline) intra-articular injection used as placebo; arms compare: 2 intra-articular injections of onabotulinumtoxina (botox) vs 1 intra-articular injection of onabotulinumtoxina + 1 injection of normal saline vs 2 intra-articular injections of normal saline. doses not specified in the provided record.-controlled Phase III trial across 5 sites in France.

Randomised
Yes
Comparator
SODIUM CHLORIDE (normal saline) intra-articular injection used as placebo; arms compare: 2 intra-articular injections of onabotulinumtoxinA (BOTOX) vs 1 intra-articular injection of onabotulinumtoxinA + 1 injection of normal saline vs 2 intra-articular injections of normal saline. Doses not specified in the provided record.
Target Sample Size
120
Trial Duration For Participant
183

Eligibility

Recruits 120 Protected adults (including individuals under guardianship by court order) are excluded. Participants must be capable of providing written informed consent (subject information and informed consent form provided). Individuals unable to speak and read French are excluded..

Pregnancy Exclusion
• Pregnant women and lactation; lack of contraception for women of childbearing potential
Vulnerable Population
Protected adults (including individuals under guardianship by court order) are excluded. Participants must be capable of providing written informed consent (subject information and informed consent form provided). Individuals unable to speak and read French are excluded.

Inclusion criteria

  • {"criterion_text":"- •\tIndividuals aged at least 18 years;\n- •\tPain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);\n- •\tPain involving the base of the thumb;\n- •\tX-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpal joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;\n- •\t1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpal osteoarthritis.\n- •\tAffiliation with a mode of social security (profit or being entitled).\n- •\tNegative pregnancy test in women of childbearing potential"}

Exclusion criteria

  • {"criterion_text":"- •\tSecondary osteoarthritis;\n- •\tUse of IM, IV or oral corticosteroids for up to 2 months.\n- •\tProtected adults (including individual under guardianship by court order)\n- •\tPregnant women and lactation; lack of contraception for women of childbearing potential\n- •\tPatient participating in another investigational therapeutic study\n- •\tPatient unable to speak and read French.\n- •\tHistory of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;\n- •\tContra-indication to onabotulinumtoxinA;\n- •\tNeurological disorders involving the hands other than carpal tunnel syndrome;\n- •\tCollagen disorders involving the hands\n- •\tOsteoarthritis predominating at the scaphotrapezial joint on x-ray;\n- •\tBilateral trapezometacarpial osteoarthritis without a predominant painful side;\n- •\tHand or wrist trauma for up to 2 months;\n- •\tIntra-articular treatments for up to 2 months;"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary efficacy end point will be mean change from baseline in base-of-thumb pain on the painful side (either left or right) in the 48h previous to the interview on a self-administered 11-point numeric rating scale at 6 months after the first intra-articular injection, analysed by intention to treat.","definition_or_measurement_approach":"Mean change from baseline in base-of-thumb pain on the painful side in the 48 hours prior to the interview measured using a self-administered 11-point numeric rating scale, assessed at 6 months after the first intra-articular injection; analysed by intention-to-treat."}

Recruitment

Planned Sample Size
120
Recruitment Window Months
36
Consent Approach
Written informed consent obtained from the participant. Participants must be capable of providing written informed consent. Subject information and informed consent form documents (e.g. L1_SIS-ICF majeur) are provided; materials and participant language requirement: individuals unable to speak and read French are excluded.

Geography

Total Number Of Sites
5
Total Number Of Participants
120

France

Earliest CTIS Part Ii Submission Date
08-11-2024
Latest Decision Or Authorization Date
25-11-2025
Processing Time Days
382
Number Of Sites
5
Number Of Participants
120

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Radiologie
Contact Person Name
Fadila Mihoubi Bouvier
Contact Person Email
fadila.mihoubibouvier@aphp.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Medecine physique et de réadaptation
Contact Person Name
Mathieu de Sèze
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Rhumatologie
Contact Person Name
Jérémie Sellam
Contact Person Email
jeremie.sellam@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Medecine physique et de réadaptation
Contact Person Name
Yves-Marie Pers
Contact Person Email
ym-pers@chu-montpellier.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Rééducation et réadaptation de l'appareil locomoteur et des pathologies du rachis
Contact Person Name
Christelle Nguyen
Contact Person Email
christelle.nguyen2@aphp.fr

Sponsor

Primary sponsor

Full Name
Assistance Publique Hopitaux De Paris
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
BOTOX 50 UNITÉS ALLERGAN, poudre pour solution injectable
Active Substance
Botulinum toxin type A
Modality
Peptide/protein/enzyme
Routes Of Administration
Intra-articular use
Route
Intra-articular
Authorisation Status
Authorised (marketing authorisation number 34009 370 831 4 0 in France)
Investigational Product Name
SODIUM CHLORIDE
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
Intra-articular use
Route
Intra-articular
Authorisation Status
No marketing authorisation listed (used as placebo)

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