Randomized, Controlled, Open Trial of Two Standardized Decline Schemes, Fast (North American) and Slow (European) Respectively, of Cortisone in Giant Cell Arteritis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Caen Normandie

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2024-11-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

CHU CAEN Normandie

External identifiers

EU CT number

2024-518653-41-00

EudraCT number

2018-000344-25

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To compare in giant cell arteritis (GCA) the rate of complete remission without any relapse in the two arms of corticosteroid therapy (long regimen of 52 weeks versus short regimen of 28 weeks) at week 52 (W52). The working hypothesis is to verify the non-inferiority of the shortened American scheme, in comparison to the extended French and European scheme.

Secondary objectives 5

1. the rates of 1st and 2nd relapses at W28 and W52
2. the time limits for the 1st and 2nd relapses to occur
3. cumulative doses of cortisone at W28 and W52
4. the levels of corticosteroid-dependent patients (defined as the inability to drop below 0.3 mg/kg at the end of the 6th month or 0.15 mg/kg at the end of the 12th month)
5. adverse effects attributable to corticosteroid therapy

Conditions and MedDRA coding

Patients with giant cell arteritis (= Horton’s disease)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. • Patients over 50 years old
2. • Diagnosis of ACG based on the presence of two of the 4 ACR 1990 bio-clinical criteria (i.e. age > 50 years and unusual headache and/or tenderness in the temporal artery pathway and/or biological inflammatory syndrome (defined as c-reactive protein >5 mg/l or sedimentation rate >50 mm at first hour) and the mandatory presence of one of the following 3 criteria:  positivity of a temporal artery biopsy or  evidence of large-vessel vasculitis (on aortic angioscan, positron emission tomography or MRI angiography) or  positivity of a temporal artery echo-Doppler performed by a recognized, experienced physician (radiologist or vascular physician).
3. • Oral corticosteroid therapy started no more than 14 days ago, excluding boluses
4. • Patient registered with the social security system
5. • Patient who has given written consent

Exclusion criteria 14

1. • Oral corticosteroid therapy started more than 14 days ago, excluding bolus therapy
2. - Psychotic states not yet controlled by treatment
3. - Immunization with a live vaccine within 8 weeks of starting treatment
4. - Pregnant women (for non-menopausal women, negative high-sensitivity pregnancy test)
5. - Women of childbearing age without effective contraception
6. • Giant cell arteritis in relapse
7. • Persistent severe dementia
8. • Non-observant patient
9. • Patient living more than 150 km from the investigating center
10. •Persons under court protection, guardianship or curatorship
11. Hypersensitivity to prednisone
12. • Any infectious condition requiring systemic treatment
13. - Evolving viruses (including hepatitis, herpes, chickenpox, shingles)
14. Patient on immunosuppressive therapy at inclusion

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. In each of the two arms (28- and 52-week regimens): number of patients in complete remission without relapse at S52, based on total number of patients included

Secondary endpoints 5

1. - Measurement of the number of 1st relapses at S28 and S52 / number of patients included - Measurement of the number of 2nd relapses at S28 and S52 / number of patients included
2. - Measurement of extremes, means and medians of time to 1st and 2nd relapses
3. - Measurement of extremes, means, and medians of durations and individual cumulative doses of cortisone relative to body weights at S28 and S52
4. - Measuring the number of patients with cortico-dependent disease at S52
5. measurement of blood pressure, weight, glycemia, glycated hemoglobin, biochemistry, infectious complications, fracture complications, glaucoma, cataracts. Screening in both arms for the onset or decompensation of type 2 diabetes and any cardiovascular events. Bone densitometry (at baseline, S28 and S52) and adverse events attributable to corticosteroid therapy as soon as consent was signed and for the duration of the study.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Caen Normandie

Sponsor organisation

Centre Hospitalier Universitaire De Caen Normandie

Address

Avenue De La Cote De Nacre, Cs 30001 Cs 30001

City

Caen Cedex 9

Postcode

14033

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

Investigateur coordinateur

Public contact point

Organisation

Centre Hospitalier Universitaire De Caen Normandie

Contact name

Investigateur Coordinateur

Locations

1 EU/EEA country · 6 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications