Giant Cell Arteritis: Comparison Between Two Standardized Corticosteroids Tapering

NCT04012905 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: 17-2492018-000344-25
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Corticosteroid therapy has always been the standard treatment for giant cell arteritis (GCA), with very good initial clinical efficacy but a high relapse rate when it declines. The target population of this condition, often elderly, is particularly exposed to the numerous undesirable effects of corticosteroid therapy, and this especially as its duration lengthens with the re-increases of doses according to relapses: metabolic complications, osteo-muscular , infectious or neuropsychiatric. Investigators propose to compare prospectively the results of a "conventional" corticosteroid regimen as recommended by European societies, to those of a "lighter and / or shorter" scheme, inspired by recent North American trials. , including the largest prospective global study in the field. Investigators hypothesize non-inferiority of the lightened regimen for relapse rate without relapse at S52, but with a decrease in treatment-related adverse events whose cumulative doses should be lower. Investigators therefore plan to include prospectively over 3 years 150 patients, 75 for each of the two arms, with a newly diagnosed ACG. A randomization of the treatment arm will be performed and a predefined pattern of cortisone adapted to body weight will be given to the patient. Relapse rates, maintenance of remission, cumulative doses of cortisone and adverse effects of treatment will be analyzed at the 52nd week of the introduction of corticosteroid therapy. An interim analysis is planned at S28.

Conditions

Giant Cell Arteritis

Keywords

Giant Cell Arteritis; Horton disease; Corticosteroids treatment; Prednisone; Relapse; Side effect; Cumulative doses

Outcome Measures

Primary Outcomes (1)

• Patient in complete remission over a follow up of 52 weeks, without relapse

  Baseline up to 52 weeks

Secondary Outcomes (6)

• First relapses rate at S28 and S52

  Weeks 28 and 52

• Second relapses rate at S28 and S52

  Weeks 28 and 52

• Delay between first and second relapses

  Baseline up to 52 weeks

• Cumulative and the average dose of prednisone used

  Weeks 28 and 52

• Number of patient with corticosteroids dependence at week 52

  Baseline up to 52 weeks

Study Arms (2)

Short tapering corticosteroids

EXPERIMENTAL

Corticosteroid taper over 28 weeks

Drug: Corticosteroids for Systemic Use

Long tapering corticosteroids

ACTIVE COMPARATOR

Corticosteroid taper over 52 weeks

Drug: Corticosteroids for Systemic Use

Interventions

Corticosteroids for Systemic Use DRUG

Corticosteroids tapering over 28 weeks: J0 = 0,7 mg/kg S2 = 0,6 mg/kg S4 = 0,5 mg/kg S6 = 0,4 mg/kg S8 = 0,3 mg/kg S10 = 0,25 mg/kg S12 = 0,2 mg/kg S14 = 0,15 mg/kg S16 = 0,15 mg/kg S20 = 0,1 mg/kg S24 = 0,05 mg/kg S28 = 0 mg/kg Corticosteroids tapering over 52 weeks: J0 = 0,7 mg/kg S2 = 0,6 mg/kg S4 = 0,6 mg/kg S6 = 0,5 mg/kg S8 = 0,4 mg/kg S10 = 0,3 mg/kg S12 = 0,25 mg/kg S14 = 0,2 mg/kg S16 = 0,175 mg/kg S20 = 0,15 mg/kg S24 = 0,125 mg/kg S28 = 0,01 mg/kg S32 to S52: - 1mg per month

Long tapering corticosteroids; Short tapering corticosteroids

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years
• Patient with temporal arteritis giant cell match 2 of the 4 criteria of the American College of Rheumatology (ACR) that given :
• a temporal artery biopsy compatible with a diagnosis of CAG or
• an abdominal thoracic aortitis diagnosed by Angio CT, MR angiography or PET scanner or
• Echo Doppler compatible with a diagnosis of CAG
• Oral corticosteroid treatment started up to 14 days, the initial dose is less or equal to 1 mg / Kg
• Patient wo has given its written consent Patient affiliated with a social security

You may not qualify if:

• Early treatment of CAG disease with a dose\> 1 mg / kg whatever the duration
• Corticosteroids already started over 14 days
• Giant arteritis cell on relapse
• dementia syndrome
• No compliant patient
• Patients who live more than 150 km from the investigation center
• Person under judicial protection, guardianship
• Hypersensitivity to prednisone or any of its excipients
• Infection requiring an systemic treatment
• Evolutive viroses (Hepatitis, Herpes, varicella-zoster virus)
• Pregnancy, breastfeeding women or women of childbearing potential not using contraception

Sponsors & Collaborators

• University Hospital, Caen: lead
• University Hospital, Lille: collaborator
• Amiens University Hospital: collaborator
• University Hospital, Rouen: collaborator
• University Hospital, Limoges: collaborator
• Central Hospital Saint Quentin: collaborator
• Central Hospital, Valenciennes: collaborator
• Central Hospital, Lisieux: collaborator

Related Publications (4)

• Bienvenu B, Ly KH, Lambert M, Agard C, Andre M, Benhamou Y, Bonnotte B, de Boysson H, Espitia O, Fau G, Fauchais AL, Galateau-Salle F, Haroche J, Heron E, Lapebie FX, Liozon E, Luong Nguyen LB, Magnant J, Manrique A, Matt M, de Menthon M, Mouthon L, Puechal X, Pugnet G, Quemeneur T, Regent A, Saadoun D, Samson M, Sene D, Smets P, Yelnik C, Sailler L, Mahr A; Groupe d'Etude Francais des Arterites des gros Vaisseaux, under the Aegis of the Filiere des Maladies Auto-Immunes et Auto-Inflammatoires Rares. Management of giant cell arteritis: Recommendations of the French Study Group for Large Vessel Vasculitis (GEFA). Rev Med Interne. 2016 Mar;37(3):154-65. doi: 10.1016/j.revmed.2015.12.015. Epub 2016 Jan 29.

  PMID: 26833145 BACKGROUND

• de Boysson H, Aouba A. Abatacept as Adjunctive Therapy for the Treatment of Giant Cell Arteritis: Comment on the Article by Langford et al. Arthritis Rheumatol. 2017 Jul;69(7):1504. doi: 10.1002/art.40105. Epub 2017 May 10. No abstract available.

  PMID: 28324917 BACKGROUND

• van der Goes MC, Jacobs JW, Boers M, Andrews T, Blom-Bakkers MA, Buttgereit F, Caeyers N, Cutolo M, Da Silva JA, Guillevin L, Kirwan JR, Rovensky J, Severijns G, Webber S, Westhovens R, Bijlsma JW. Monitoring adverse events of low-dose glucocorticoid therapy: EULAR recommendations for clinical trials and daily practice. Ann Rheum Dis. 2010 Nov;69(11):1913-9. doi: 10.1136/ard.2009.124958. Epub 2010 Aug 6.

  PMID: 20693273 BACKGROUND

• Proven A, Gabriel SE, Orces C, O'Fallon WM, Hunder GG. Glucocorticoid therapy in giant cell arteritis: duration and adverse outcomes. Arthritis Rheum. 2003 Oct 15;49(5):703-8. doi: 10.1002/art.11388.

  PMID: 14558057 BACKGROUND

MeSH Terms

Conditions

Giant Cell Arteritis; Recurrence

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Hubert De BOYSSON, MD

  University Hospital, Caen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hubert De BOYSSON, MD

CONTACT

02 31 06 57 32; deboysson-h@chu-caen.fr

Audrey SULTAN, PhD

CONTACT

02 31 06 33 58; sultan-a@chu-caen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 9, 2019
• Study Start: November 5, 2020
• Primary Completion: November 1, 2023
• Study Completion (Estimated): January 1, 2027
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share