Clinical trial • Phase IV • Endocrinology|Ophthalmology|Immunology
Atorvastatin for Graves ophthalmopathy|Graves' disease
Phase IV trial of Atorvastatin for Graves ophthalmopathy|Graves' disease. 554 participants.
Overview
- Trial Therapeutic Area
- Endocrinology|Ophthalmology|Immunology
- Trial Disease
- Graves ophthalmopathy|Graves' disease
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 08-12-2025
- First CTIS Authorization Date
- 04-02-2026
Trial design
Phase IV trial across 9 sites in Sweden.
- Target Sample Size
- 554
- Trial Duration For Participant
- 548
Eligibility
Recruits 554 Vulnerable populations are not selected for inclusion (isVulnerablePopulationSelected: false). Exclusion includes: 'Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial'. Subject information and informed consent forms are listed (documents L1_SIS and ICF)..
- Pregnancy Exclusion
- Pregnancy, planned pregnancy within 12 months or lactation
- Vulnerable Population
- Vulnerable populations are not selected for inclusion (isVulnerablePopulationSelected: false). Exclusion includes: 'Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial'. Subject information and informed consent forms are listed (documents L1_SIS and ICF).
Inclusion criteria
- {"criterion_text":"- Age 18–85 years"}
- {"criterion_text":"- Diagnosis of Graves' Disease (GD):TSH < 0.1 μU/L.\tElevated free T4 (fT4) and/or free T3 (fT3). \tPositive TSH receptor antibodies (TRAb)."}
- {"criterion_text":"- Sufficient knowledge of Swedish to understand medical information and participate in telephone or video calls."}
Exclusion criteria
- {"criterion_text":"- Pregnancy, planned pregnancy within 12 months or lactation"}
- {"criterion_text":"- Concurrent use of medications that interact with statins, particularly CYP3A4 inhibitors or inducers."}
- {"criterion_text":"- Need of corticosteroid protection for planned radioiodine therapy"}
- {"criterion_text":"- Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial"}
- {"criterion_text":"- Prior treatment with statins, selenium, corticosteroids, or other immunosuppressive medications for more than 7 days within the 3 months preceding GD diagnosis."}
- {"criterion_text":"- Existing Graves' Ophthalmopathy (GO) at the time of GD diagnosis."}
- {"criterion_text":"- Known hypersensitivity to atorvastatin or other statins."}
- {"criterion_text":"- Active liver disease."}
- {"criterion_text":"- Alcohol abuse."}
- {"criterion_text":"- Elevated liver enzymes (ASAT/ALAT > 3 times the upper normal limit in two consecutive tests)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The proportion of patients developing active GO after 12 months, defined as a Clinical Activity Score (CAS) ≥3. CAS is a standardized method for assessing the activity of GO.","definition_or_measurement_approach":"Defined as Clinical Activity Score (CAS) ≥3; CAS is a standardized method for assessing activity of GO."}
Secondary endpoints
- {"endpoint_text":"- Proportion of patients developing clinical GO at 3, 6, 9, 15, and 18 months.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time from GD diagnosis to GO onset.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Highest CAS recorded during the study period.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Proportion of patients requiring interventions such as corticosteroids, orbital irradiation, or biologics (e.g., rituximab or teprotumumab).","definition_or_measurement_approach":""}
- {"endpoint_text":"- Change in quality-of-life scores as measured by validated tools, including GO-QoL and Thyr-Pro questionnaires, at baseline, 12 months, and 18 months.","definition_or_measurement_approach":"Measured by validated tools GO-QoL and Thyr-Pro at baseline, 12 months, and 18 months."}
- {"endpoint_text":"- Levels of TSH-receptor antibodies (TRAb) at 12 and 18 months","definition_or_measurement_approach":""}
- {"endpoint_text":"- Identification of new GO-related biomarkers using proteomics and microarray analysis.","definition_or_measurement_approach":""}
- {"endpoint_text":"- Genetic differences between responders and non-responders to atorvastatin, identified via genome-wide association studies (GWAS) and analyses of relevant single nucleotide polymorphisms (SNPs).","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 554
- Recruitment Window Months
- 56
- Consent Approach
- Informed consent to be obtained from adult participants (age 18–85). Participants must have sufficient knowledge of Swedish to understand medical information and participate in telephone or video calls. Subject information and informed consent form documents are listed (L1_SIS and ICF).
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 554
Sweden
- Earliest CTIS Part Ii Submission Date
- 26-01-2026
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 9
- Number Of Sites
- 9
- Number Of Participants
- 554
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- VE Endokrinologi SUS Lund, Lasarettsgatan 15, 221 85 Lund
- Principal Investigator Name
- Erik Uddman
- Principal Investigator Email
- erik.uddman@skane.se
- Contact Person Name
- Erik Uddman
- Contact Person Email
- erik.uddman@skane.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Invärtesmedicin och klinisk nutrition, Vita Stråket 11, Sahlgrenska Universitetssjukhuset, Göteborg
- Principal Investigator Name
- Helena Filipsson Nyström
- Principal Investigator Email
- helena.filipsson@medic.gu.se
- Contact Person Name
- Helena Filipsson Nyström
- Contact Person Email
- helena.filipsson@medic.gu.se
- Site Name
- S:t Eriks Oegonsjukhus AB
- Department Name
- KI, St Eriks ögonsjukhus, Eugeniavägen 12, 17141 Stockholm
- Principal Investigator Name
- Frank Träisk
- Principal Investigator Email
- frank.traisk@regionstockholm.se
- Contact Person Name
- Frank Träisk
- Contact Person Email
- frank.traisk@regionstockholm.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- VE Endokrinologi, SUS Malmö, Tora Kjellgrens gata 17, 205 02 Malmö
- Principal Investigator Name
- Tereza Planck
- Principal Investigator Email
- tereza.planck@skane.se
- Contact Person Name
- Tereza Planck
- Contact Person Email
- tereza.planck@skane.se
- Site Name
- Region Oerebro Laen
- Department Name
- Endokrinologen, Örebro universitetssjukhus
- Principal Investigator Name
- Jeanette Wahlberg Hughes
- Principal Investigator Email
- jeanette.wahlberg@oru.se
- Contact Person Name
- Jeanette Wahlberg Hughes
- Contact Person Email
- jeanette.wahlberg@oru.se
- Site Name
- Region Vaesterbotten
- Department Name
- Norrlands universitetssjukhus, Daniel Naezéns väg, 907 37 Umeå, Medicincentrum
- Principal Investigator Name
- Marcus Imamovic
- Principal Investigator Email
- marcus.imamovic@umu.se
- Contact Person Name
- Marcus Imamovic
- Contact Person Email
- marcus.imamovic@umu.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- VE Ögonsjukvård, Skånes Universitetssjukhus, Tora Kjellgrens gata 17, 20502 Malmö
- Principal Investigator Name
- Sabina Andersson Geimer
- Principal Investigator Email
- sabina.anderssongeimer@skane.se
- Contact Person Name
- Sabina Andersson Geimer
- Contact Person Email
- sabina.anderssongeimer@skane.se
- Site Name
- Uppsala University Hospital
- Department Name
- Sektionen för endokrin och diabetes, Sjukhusvägen ingång 40, Akademiska sjukhuset
- Principal Investigator Name
- Selwan Khamisi
- Principal Investigator Email
- selwan.khamisi@medsci.uu.se
- Contact Person Name
- Selwan Khamisi
- Contact Person Email
- selwan.khamisi@medsci.uu.se
- Site Name
- Karolinska University Hospital
- Department Name
- ME Endokrinologi, Karolinska vägen 37A, 17176 Stockholm
- Principal Investigator Name
- Ileana Botusan
- Principal Investigator Email
- ileana.botusan@regionstockholm.se
- Contact Person Name
- Ileana Botusan
- Contact Person Email
- ileana.botusan@regionstockholm.se
Sponsor
Primary sponsor
- Full Name
- Region Skane
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- Atorvastatin Viatris 40 mg Filmtabletten
- Active Substance
- Atorvastatin
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (marketed product)
- Starting Dose
- 40 mg
- Dose Levels
- 40 mg
- Maximum Dose
- 40 mg
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