Overview
Sponsor-declared trial summary
polymyalgia rheumatica
To investigate whether the use of leflunomide can prevent relapses during corticosteroid tapering in patients with polymyalgia rheumatica
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 1 Sep 2024 → ongoing
- Decision date (initial)
- 2024-08-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514210-12-00
- EudraCT number
- 2017-001079-22
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Others, Safety
To investigate whether the use of leflunomide can prevent relapses during corticosteroid tapering in patients with polymyalgia rheumatica
Conditions and MedDRA coding
polymyalgia rheumatica
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Female or male aged ≥ 50 years 2. PMR according to the ACR/EULAR 2012 PMR core (essential) classification criteria 3. Newly diagnosed PMR being on corticosteroids glucocorticoids for less than 4 weeks
Exclusion criteria 1
- 1. Presence of any other connective tissue disease, including vasculitis/giant-cell arteritis 2. PMR on glucocorticoidsglucocorticosteroids for >4 week or >25 mg/day 3. History of alcohol or drug abuse or current alcohol or drug abuse 4. Transplanted organ (except corneal transplant performed more than 3 months prior to screening) 5. Evidence (as assessed by the investigator) of active infection, presence of hepatitis B surface antigen or hepatitis C antibody in blood, HIV positivity. 6. Malignancy within 5 years prior to screening, except for nonmelanoma skin cancer 7. Exposure to DMARD/biological in the last 5 years 8. Pain syndromes, e.g. fibromyalgia, drug-induced myalgia 9. Active thyroid disease 10. Neurological diseases, e.g. Parkinson's disease 11. Contraindications for leflunomide 12. Laboratory abnormalities: renal or hepatic impairment, anemia and significant cytopenia 13. Uncontrolled or poorly controlled hypertension 14. Major surgery or hospitalization within 3 month prior to screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- the time to the first relapse at 12 months
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Leflunomide Mylan 10 mg, filmomhulde tabletten
PRD10157344 · Product
- Active substance
- Leflunomide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 14600 mg milligram(s)
- Max treatment duration
- 104 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AA13 — LEFLUNOMIDE
- Marketing authorisation
- RVG 106344
- MA holder
- MYLAN PHARMACEUTICALS LIMITED
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- It will be over-encapsulated in Blue opaque oblong shaped capsules size 0
Comparator 1
SUB21402 · Substance
- Active substance
- Placebo
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- It will be over-encapsulated in Blue opaque oblong shaped capsules size 0
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- E. Brouwer
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- E. Brouwer
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 94 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-09-01 | 2024-09-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514210-12-00_redacted | 2 |
| Recruitment arrangements (for publication) | Blanc document | 1 |
| Subject information and informed consent form (for publication) | L1_ICF | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_redacted | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Blanc document | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-23 | Netherlands | Acceptable with conditions 2024-08-12
|
2024-08-12 |