Giant Cell Arteritis and Anakinra Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02902731
• Date of registration: 05/07/2016
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Caen
• Public title: Giant Cell Arteritis and Anakinra Trial GiAnT
• Scientific title: Randomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell Arteritis
• Date of first enrolment: May 11, 2017
• Target sample size: 70
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02902731
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Achille AOUBA, MD PHD
• Affiliation: CHU CAEN

• Name: Achille AOUBA, MD PHD

Key inclusion & exclusion criteria

Minimum Age: 51 Years

Maximum Age:

Gender: Both Accepts Healthy Volunteers?: No

Criteria:

Inclusion Criteria: (Giant cell arteritis = GCA)

Age = 50 years

Patient with temporal arteritis giant cell match 3 of the 5 criteria of the American
College of Rheumatology (ACR) that:

Given a temporal artery biopsy compatible with a diagnosis of GCA (not necrotizing
arteritis, giant cell with a granulomatous inflammatory infiltrate, usually localized to
the intima-media junction, makes lymphocytes, macrophages and multinucleated giant cells;
or minimum detection of a chronic inflammatory infiltrate fact lymphocytes and some
neutrophils or eosinophils without giant cells).

Either abdominal thoracic aortitis diagnosed by:

- Angio CT: circumferential thickening of the aortic wall more than 3 mm, in the absence
of adjacent plaque and active infection.

- MR angiography: wall thickening of the aortic wall with hyperintense on T1 weighted
and T2 weighted enhancement after gadolinium injection.

- PET scanner: increased uptake of FDG by the aorta and its branches is not typical for
GCA and may be in the atheroma. The PET scanner is probably a very sensitive technique
but not specific enough to retain the diagnosis of GCA. We therefore consider the PET
CT as a diagnostic method of secondary aortite the GCA if there simultaneously on the
same exam fixing aortic (thoracic or abdominal) and blood of large caliber (artery (s)
axillary ( s), subclavian (s) and / or carotid (s) of FDG.

Newly diagnosed disease and from corticosteroid started up to 14 days, the initial dose is
less or equal to1 mg / Kg or

GCA recurrence of continuous therapy with corticosteroids (including hydroprednisone) and /
or immunosuppression was stopped for at least 6 months. At the time of recurrence, at least
3 of 5 ACR criteria for the diagnosis of GCA must be present. Furthermore :

- if BAT (Biopsy of the temporal artery) was positive at the time of initial diagnosis,
it is not necessary to make a new.

- if BAT was negative, the patient can not be included after completion of a new BAT
which will be positive or if there is a aortite, evidenced by angio-CT or MR
angiography or PET scanner.

For men and women of childbearing age, effective contraception must be used in the patient
or his partner for the duration of treatment with anakinra (or placebo) and for 3 months
after treatment. Also, breastfeeding is allowed after 3 months of stopping anakinra. Women
considered not at risk of pregnancy are defined with menopause for at least a year or
surgically sterile (tubal ligation, bilateral oophorectomy or hysterectomy)

Patient wo has given its written consent Patient affiliated with a social security

Exclusion Criteria:

Subjects checking one of the criteria for non-inclusion may be eligible to participate in
the research. These criteria may include:

1. pathologies, habitus or other patient characteristics

- Pregnancy, breastfeeding women or women of childbearing potential not using
contraception

- dementia syndrome

- Patient not observing

- Patients who live more than 150 km from the investigation center

- ethyl or drug intoxication history that required hospitalization in the previous
year

- Patient monitoring and / or treated to another autoimmune disease or known
inflammatory

- Hypersensitivity to anakinra or any of its excipients (Sodium citrate (E331),
sodium chloride, disodium edetate (E385), polysorbate 80 (E433), sodium hydroxide
(E524), water for injections, substrates of origin: Escherichia coli proteins)

- Person under judicial protection, guardianship

- Person deprived of liberty

- Person not beneficiaries of the social security system

2. Other therapeutic

- Patient has already started (or stopped there less than 6 months) in a protocol or
not frame to its ACG or another disease, treatment with anti TNF-alpha, methotrexate,
cyclosporine, cyclophosphamide, dapsone or bolus corticosteroids.

- Patients on long-term glucocorticoid for another condition

- Early treatment of CAG disease with a dose> 1 mg / kg whatever the duration

- Immunization with live vaccines / mitigated during the 8 weeks

3. Infectious diseases

- Chronic viral hepatitis (acute or) B or C

- HIV Infection

- Persistent infection or severe infection requiring hospitalization or treatment
with IV antibiotics during the 30 days prior to inclusion

- Infection requiring an oral antibiotic treatment in the preceding 14 days
inclusion

- History of active tuberculosis, histoplasmosis or listeriosis

- latent TB Signs (based on a history of untreated contagion, an opacity of greater
than 1 cm in diameter on chest x-ray, or an in vitro test (Quantiferon Gold or
T-Spot TB) positive. A history of tuberculosis disease or latent TB whose
treatment is completed and has been properly conducted is not an exclusion
criterion, whatever the result of Quantiferon or T-Spot TB.

4. Unstable disease

- Uncontrolled diabetes with a history of recurrent infections

- unstable ischemic heart

- Heart failure = stage III / IV NYHA

- Stroke recent (<6 months)

- Or any other severe disease resulting in the opinion of the investigator, a risk
to the patient due to its participation in the study.

5. A vascular risk, metabolic, infectious, neoplastic renal or as follows:

• Patient at high cardiovascular risk: heart disease or vascular history of proven,
type 2 diabetes at high cardiovascular risk *, vascular risk> 20% at 10 years
(Framingham equation) Dyslipidemia • severe uncontrolled lipid-lowering therapy

- Active Liver disease and liver failure

- Neutropenia (<1500 / mm3) at the time of the introduction of Kineret / Placebo;
and a patient with initial neutropenia may be included in the study if it
corrects under Cortancyl®, and that the experimental treatment (Anakinra-Kineret
/ PLACEBO) may be commenced within 15 days after prednisone.

Neoplasia under 5 years except carcinoma in situ of the cervix and skin cancer
(excluding melanoma) with complete excision whose boundaries pass in safe area.

• Severe renal impairment (clearance <30mL / min)

* The high


Age minimum: 51 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Giant Cell Arteritis

Intervention(s)

Drug: ANAKINRA

Drug: PLACEBO

Primary Outcome(s)

global relapse rate [Time Frame: Week 26]

Secondary Outcome(s)

speed efficiency : time of obtaining a complete remission over a follow up of 52 weeks period [Time Frame: baseline up to 52 weeks]

cumulative and the average dose of prednisone used [Time Frame: baseline up to 52 weeks]

Safety according CTCAE v4.0 [Time Frame: baseline up to 52 weeks]

specific relapse rate [Time Frame: W27 to W52]

number of first relapse [Time Frame: baseline up to 52 weeks]

specific relapse rate [Time Frame: Week 17 to Week 26]

specific relapse rate [Time Frame: Week 4 to Week 16]

Secondary ID(s)

2015-005804-27 N° CHU : 15-200

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Central Hospital Saint Quentin

University Hospital, Rouen

Valenciennes Hospital, Valenciennes, FRANCE

Amiens University Hospital

Hôpital Claude-Huriez

University Hospital, Limoges