Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
90
Countries
1
Sites
11
Raynaud phenomenon
To compare the onset of a SSc after 5 years in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Bordeaux
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Immune system processes [G12]
- Trial duration
- 22 Jun 2022 → ongoing
- Decision date (initial)
- 2024-02-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Ministère de la Santé (France)
External identifiers
- EU CT number
- 2024-511005-39-00
- EudraCT number
- 2020-000309-10
- ClinicalTrials.gov
- NCT05098704
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
To compare the onset of a SSc after 5 years in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
Secondary objectives 4
- To compare after 2 and 5 years the onset of a skin fibrosis in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
- To compare after 2 and 5 years the extent of skin fibrosis in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
- To compare after 2 and 5 years the risk of degradation of the Cochin Hand Function Scale in patients with specific dysimmunity and RP treated either with clopidogrel or with placebo.
- Assessment of clinical, demographic, biologic or capillaroscopic prognosis factors associated with a higher risk to develop an SSc when presenting with specific dysimmunity and RP.
Conditions and MedDRA coding
Raynaud phenomenon
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Experimental period Two groups of patients with a 2:1 randomization ratio: 1) Clopidogrel treated subjects; 2) Placebo treated subjects.
Subjects will be included and treated during a 2-year period.
|
Randomised Controlled | Double | [{"id":131188,"code":1,"name":"Subject"},{"id":131186,"code":2,"name":"Investigator"},{"id":131185,"code":5,"name":"Carer"},{"id":131187,"code":3,"name":"Monitor"}] | Experimental: Drug: clopidogrel treatment - 75 mg daily during 24 months Placebo Comparator: Drug: Placebo - 1 capsule daily during 24 months |
| 2 | Following patient Subjects will be followed for a period of 36 months after treatment.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patient over 18 years old, and less than 85 years old.
- Patient with positive AAN (AAN ≥ 1/160) with the following specificity: anti-Scl70 or anti-centromere, anti-RNApolIII, or any other autoantibodies related to systemic sclerosis.
- Patient with RP reported by the subject and confirmed by the physician.
- Patient affiliated to a health insurance system.
- Patient who accepts to participate to the study and signs an inform consent form.
Exclusion criteria 8
- Patient with an SSc diagnosis according to ACR/EULAR 2013 criteria.
- Patient with skin fibrosis at screening.
- Patient with antiplatelet treatment at screening.
- Patient with contraindications to clopidogrel.
- Patient treated by immunosuppressive agent at screening.
- Patient treated by anticoagulants at screening.
- Women of childbearing age refusing effective contraception method during the the study treatment (24 months).
- Incompetent adults (i.e. Individuals under the protection of a conservator).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence of SSc at 5 years according to ACR / EULAR 2013 criteria in the two randomization groups
Secondary endpoints 4
- Frequency of occurrence of cutaneous fibrosis (sclerodactyly or other affected area) clinically assessed by at least 2 independent investigators in the two randomization groups
- Mean of modified Rodman skin score in the two randomization groups
- Mean of Cochin Hand Function Scale in the two randomization groups
- Demographic (sex, age, environmental factors), clinical (associated diseases, history), biological, capillaroscopic criteria in the two randomization groups
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Plavix 75 mg film-coated tablets
PRD2912281 · Product
- Active substance
- Clopidogrel
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 75 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- B01AC04 — CLOPIDOGREL
- Marketing authorisation
- EU/1/98/069/005
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Non applicable - Placebo
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Bordeaux
- Sponsor organisation
- Centre Hospitalier Universitaire De Bordeaux
- Address
- 12 Rue Dubernat, Cs 91286 Cs 91286
- City
- Talence
- Postcode
- 33400
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Bordeaux
- Contact name
- Coordinating Investigator
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Bordeaux
- Contact name
- Coordinating Investigator
Locations
1 EU/EEA country · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 90 | 11 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Montpellier
Médecine Vasculaire, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Hospitalier De Pau
Médecine Interne, 4 Boulevard Hauterive, 64000, Pau
Centre Hospitalier Universitaire De Toulouse
Médecine Interne, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Pellegrin Hospital
Rhumatologie, Place Amelie Raba Leon, 33000, Bordeaux
Centre Hospitalier General De Libourne
Rhumatologie, 112 Rue De La Marne, Bp 199, Libourne Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Rhumatologie, Boulevard Tanguy Prigent, 29609, Brest Cedex 2
Centre Hospitalier De La Cote Basque
Rhumatologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Universitaire Grenoble Alpes
Médecine vasculaire, Pavillon E, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble Cedex 09
Assistance Publique Hopitaux De Paris
Médecine Interne, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Intercommunal De Mont De Marsan Et Du Pays Des Sources
Médecine Interne, Avenue Pierre De Coubertin, Bp 417, Mont-De-Marsan Cedex
Centre Hospitalier Universitaire De Bordeaux
médecine Interne et maladies infectieuses, 1 Rue Jean Burguet, Cs 11261, Bordeaux Cedex
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2022-06-22 | 2022-06-22 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-511005-39-00_public | 5.0 |
| Protocol (for publication) | D2_Protocol modification 2024-511005-39-00 | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_genetics ICF adults_CLEAN | 2 |
| Subject information and informed consent form (for publication) | L1_ICF adults_CLEAN | 2 |
| Subject information and informed consent form (for publication) | L1_SIS adults_CLEAN | 4 |
| Subject information and informed consent form (for publication) | PSSIT_CE | 1 |
| Subject information and informed consent form (for publication) | PSSIT_Consentement expres genetique | 1.1 |
| Subject information and informed consent form (for publication) | PSSIT_NI | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | PSSIT_Plavix_75mg_RCP | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2024-511005-39-00_CLEAN_public | 3.0 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-12 | France | Acceptable 2024-02-15
|
2024-02-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-12 | France | Acceptable 2024-05-29
|
2024-05-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-14 | France | Acceptable | 2024-10-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-21 | France | Acceptable 2025-07-09
|
2025-07-11 |