RHIBOT II - Medium- and long-term efficacy of two ultrasound-guided intra-articular injections of onabotulinumtoxinA (Botox®) combined with custom-made rigid splinting in painful base-of-thumb osteoarthritis : a randomized double-blind controlled trial in three-parallel arms

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

3 Dec 2025 → ongoing

Decision date (initial)

2025-01-24

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

French Ministry of Health Programme Hospitalier de Recherche Clinique National 2022

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Our main objective will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain at 6 months after the first injection

Secondary objectives 1

1. Our secondary objectives will be to compare the effects of 2 intra-articular injections of onabotulinumtoxinA with those of 1 intra-articular injection of onabotulinumtoxinA and 1 of normal saline and those of 2 intra-articular injections of normal saline on base-of-thumb pain during follow-up, hand-specific activity limitations, patient global assessment, health-related quality of life, Osteoarthritis Research Society International-Outcome Measures in Rheumatology response and economic evaluation

Conditions and MedDRA coding

Adults aged at least 18 years with painful base-of-thumb osteoarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. • Individuals aged at least 18 years;
2. • Pain intensity of at least 30 on a self-administered 11-point pain numeric rating scale (0: no pain to 100: maximal pain);
3. • Pain involving the base of the thumb;
4. • X-ray evidence of trapezometacarpial osteoarthritis with at least two of the following items involving the trapezometacarpial joint: osteophytes, joint space narrowing, subchondral bone sclerosis, or subchondral cysts;
5. • 1990 ACR classification criteria for hand osteoarthritis adapted to trapezometacarpial osteoarthritis.
6. • Affiliation with a mode of social security (profit or being entitled).
7. • Negative pregnancy test in women of childbearing potential

Exclusion criteria 14

1. • Secondary osteoarthritis;
2. • History of thumb surgery, inflammatory or crystal-associated rheumatic disease, or epilepsy;
3. • Contra-indication to onabotulinumtoxinA;
4. • Neurological disorders involving the hands other than carpal tunnel syndrome;
5. • Collagen disorders involving the hands
6. • Osteoarthritis predominating at the scaphotrapezial joint on x-ray;
7. • Bilateral trapezometacarpial osteoarthritis without a predominant painful side;
8. • Hand or wrist trauma for up to 2 months;
9. • Intra-articular treatments for up to 2 months;
10. • Use of IM, IV or oral corticosteroids for up to 2 months.
11. • Protected adults (including individual under guardianship by court order)
12. • Pregnant women and lactation; lack of contraception for women of childbearing potential
13. • Patient participating in another investigational therapeutic study
14. • Patient unable to speak and read French

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Christelle NGUYEN

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Pr Christelle NGUYEN

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications