Overview
Sponsor-declared trial summary
Graves´ ophthalmopathy
To evaluate Graves´ ophthalmopathy (GO) activity and progress to severe GO in patients with mild to moderate GO who are treated with diclofenac, simvastatin or do not receive additional treatment.
Key facts
- Sponsor
- Region Skane
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 11 Dec 2017 → ongoing
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517833-42-00
- EudraCT number
- 2015-004334-99
- ClinicalTrials.gov
- NCT03131726
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate Graves´ ophthalmopathy (GO) activity and progress to severe GO in patients with mild to moderate GO who are treated with diclofenac, simvastatin or do not receive additional treatment.
Secondary objectives 1
- evaluate modified CAS, levels of thyroid antibodies, patient quality of life, novel markers
Conditions and MedDRA coding
Graves´ ophthalmopathy
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Age 18-70 years 2. Active mild to moderate with at least one sign of mild GO (NO SPECS class 2a and b) with reference to Colour Atlas at EUGOGO website (www.eugogo.eu). Exophthalmos up to 24 mm with a disease duration of <18 months (as recorded by the patient). 3. Graves´ disease with clinical and laboratory euthyroidism • after stopping treatment with anti-thyroid drugs (ATD), or • after at least 2 months treatment with ATD, or • at least 6 months after treatment with radioiodine, or • after total thyroidectomy.
Exclusion criteria 1
- 1. Pregnancy or breast-feeding 2. Previous treatment of Graves´ ophthalmopathy 3. Severe Graves´ ophthalmopathy requiering corticosteroid treatment, retrobulbar irradiation, or orbital decompression surgery 4. Current or previous treatment with diclofenak (for more than 7 consecutive days during the previous 3 months), simvastatin or other statins (during the last 3 months) 5. Allergy (skin rash or systemic reactions) to NSAID, ASA or statins 6. Congestive heart failure 7. Renal insufficiency (glomerular filtration rate <60 ml/min) 8. ASAT or ALAT > 2.5 times the upper limit of the local laboratory 9. Alcoholism as judged by local criteria 10. Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs 11. Previous or current gastric ulcer 12. Inflammatory bowel disease 13. Diabetic retinopathy or nephropathy 14. Trauma during the last 10 days
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 1. Clinical activity score (CAS) and progression to severe GO after 6 months of treatment with diclofenac, simvastatin or no additional treatment.
Secondary endpoints 1
- 1. Modified CAS is better than CAS in discriminating changes in activity score? 2. Conjunctival thickness with optical coherence tomography after 3 and 6 months treatment with diclofenac, simvastatin or no additional treatment 3. Quality of life after 6 months treatment with diclofenac, simvastatin or no additional treatment 4. Changes in TRAb and TPOAb after 3 and 6 months treatment with diclofenac, simvastatin or no additional treatment 5. Novel markers of active ophthalmopathy
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP1003273 · ATC
- Active substance
- Simvastatin
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 7200 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- C10AA01 — SIMVASTATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10370645 · ATC
- Active substance
- Diclofenac Diethylamine
- Substance synonyms
- DICLOFENAC DIETHYLAMMONIUM
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- M01AB05 — DICLOFENAC
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Skane
- Sponsor organisation
- Region Skane
- Address
- Dockplatsen 26, Malmo S:t Petri Malmo S:t Petri
- City
- Malmo
- Postcode
- 211 74
- Country
- Sweden
Scientific contact point
- Organisation
- Region Skane
- Contact name
- Tereza Planck
Public contact point
- Organisation
- Region Skane
- Contact name
- Tereza Planck
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 102 | 1 |
| 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 |
|---|---|---|---|---|---|
| Sweden | 2017-12-11 | 2018-01-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517833-42-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Diclofenac 50 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Simvastatin 40 mg | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE_2024-517833-42-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-04 | Sweden | Acceptable 2024-12-02
|
2024-12-02 |