NCT03131726

Brief Summary

In an investigator initiated multicenter trial (Malmö, Odense, Århus) the investigators aim at evaluating activity of Graves´ophthalmopathy (GO) and progress to severe GO in patients with mild to moderate Graves´ ophthalmopathy treated with simvastatin or no treatment.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
23mo left

Started Jan 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Jan 2018Mar 2028

First Submitted

Initial submission to the registry

March 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

January 26, 2018

Completed
9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

September 25, 2024

Status Verified

September 1, 2024

Enrollment Period

9 years

First QC Date

March 10, 2017

Last Update Submit

September 23, 2024

Conditions

Graves OphthalmopathyThyroid Associated OphthalmopathyThyroid Associated Orbitopathy

Keywords

simvastatindiclofenac

Outcome Measures

Primary Outcomes (2)

  • Change in Clinical activity score (CAS) after 6 months

    Change in 7-point clinical activity score (CAS) after 6 months treatment with simvastatin or no treatment

    6 months

  • Number of patients with progression to severe GO during 6 months

    Number of patients with progression to severe GO in each group (simvastatin, no treatment) during 6 months treatment

    6 months

Secondary Outcomes (7)

  • Change in Modified Clinical activity score

    3 and 6 months

  • Optical coherence tomography

    3 and 6 months

  • Quality of life with SF36

    6 months

  • Quality of life with ThyrPro

    6 months

  • Quality of life with GO-QoL

    6 months

  • +2 more secondary outcomes

Study Arms (2)

Simvastatin

EXPERIMENTAL

simvastatin 40 mg daily for 6 months

Drug: Simvastatin 40mg

No treatment

NO INTERVENTION

No treatment

Interventions

Simvastatin 40mgDRUG

see arm description

Also known as: ATC-code: C10AA01
Simvastatin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years
  • 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)
  • Graves´ disease with clinical and laboratory euthyroidism after stopping treatment with anti thyroid drugs (ATD), or 2 months treatment with ATD, or euthyroid 6 months after treatment with radioiodine, or euthyroid after total thyroidectomy. Clinical and laboratory euthyroidism is defined as normal fT4, fT3 and TSH below the upper limit of the local reference interval and no clinical symptoms or signs of hyperthyroidism. L-thyroxine is used to achieve euthyroidism during the study period.

You may not qualify if:

  • Pregnancy or breast-feeding
  • Previous treatment of Graves´ ophthalmopathy
  • Severe Graves ophthalmopathy requiring corticosteroid treatment, retrobulbar irradiation, orbital decompression surgery
  • Current or previous treatment with simvastatin or other statins (within 3 months)
  • Allergy (skin rash or systemic reactions) to statins
  • Congestive heart failure
  • Renal insufficiency (glomerular filtration rate \<60 ml/min)
  • ASAT or ALAT \> 2.5 times the upper limit of the local laboratory
  • Alcoholism as judged by local criteria
  • Coagulopathy including treatment with warfarin or new oral anti-coagulation drugs
  • Previous or current gastric ulcer
  • Inflammatory bowel disease diabetic retinopathy or nephropathy
  • Trauma within 10 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dpt. of Endocrinology, SUS Malmö

Malmo, Sweden

RECRUITING

MeSH Terms

Conditions

Graves Ophthalmopathy

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesGraves DiseaseExophthalmosOrbital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGoiterThyroid DiseasesEndocrine System DiseasesHyperthyroidismAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Tereza Planck, MD, PhD

    Lund University and Skåne University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tereza Planck, MD, PhD

CONTACT

+46-733873399tereza.planck@med.lu.se

Sabina Andersson, MD, PhD

CONTACT

sabina.andersson_geimer@med.lu.se

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

April 27, 2017

Study Start

January 26, 2018

Primary Completion (Estimated)

January 26, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

September 25, 2024

Record last verified: 2024-09

Locations

SE(1)