Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT03711448
• Date of registration: 15/10/2018
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire Dijon
• Public title: Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis ULTRA
• Scientific title: Ustekinumab for the Treatment of Relapse of Refractory Giant Cell Arteritis
• Date of first enrolment: January 7, 2019
• Target sample size: 38
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03711448
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Maxime SAMSON

• Name: Maxime SAMSON

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written consent

- Patient with GCA, defined by the following criteria (collected at the time of
diagnosis of GCA):

- Age = 50 years old

- AND sedimentation rate VS = 50 mm/h or C-reactive protein CRP = 20 mg/L (optional
if the temporal artery biopsy (TAB) is positive)

- AND clinical signs of GCA or signs of rhisomelic pseudopolyarthritis (RPP)

- AND positive TAB (granulomatous vasculitis lesions) OR evidence of vasculitis of
large vessels (aorta or supra-aortic trunks) by angio-TDM, PET-scanner and/or
angio-MRI.

- CRP elevation >10 mg/L on at least one occasion during the 6 weeks prior to inclusion

- Relapse treatment initiated less than 6 weeks ago

- Patient with GCA relapse at a dose of prednisone = 20 mg/d and who has received at
least 12 consecutive weeks of corticosteroid therapy since the diagnosis of GCA.
Relapse is defined as the reappearance of clinical or radiological sign(s) of GCA
after a remission phase of at least 1 month AND despite well followed treatment:

- headache (> 1 day, not relieved by paracetamol and not identical to headache that
the patient may have had in the past and that is not related to GCA)

- hyperesthesia of the scalp, claudication of the jaws or tongue, anomaly of the
temporal artery

- visual signs related to GCA

- signs of RPP

- non-infectious fever of more than one week

- aggravation, recurrence or appearance of signs of vasculitis of large vessels
with angioscanner, angio-MRI or PET scanner

- any other sign related to the activity of the GCA as determined by the
investigator

Exclusion Criteria:

- Person not affiliated to or not benefiting from a health insurance system

- Weight < 40kg or > 100kg (at inclusion)

- Non-compliant patient

- Adult unable to express consent

- Patient with a psychotic state not controlled by treatment

- Person subject to a measure of legal protection (curatorship, guardianship)

- Person subject to judicial control

- Women who have not gone through menopause

- Hypersensitivity to ustekinumab, to any of its excipients or to any other murine or
human monoclonal antibody

- Latex hypersensitivity (because the packaging of ustekinumab contains latex, which is
only present in syringes)

- Relapse with the presence of obvious ophthalmological signs requiring high-dose
corticotherapy (1 mg/kg and/or methylprednisolone bolus)

- Surgery scheduled within 12 months (excluding low-risk surgery: endoscopy,
bronchoscopy, hysteroscopy, cystoscopy, biopsy or breast surgery, dental care, dental
extractions, eye surgery, outpatient surgery, skin surgery)

- Patient with other autoimmune or auto-inflammatory disease (except RPP, autoimmune
thyroiditis, Addison's disease, type 1 diabetes, Biermer's disease and presence of
autoantibodies without clinical manifestation)

- Neoplasia < 5 years (excluding in situ cervical cancer and skin carcinomas, excluding
melanomas, with healthy margin resections [R0]).

- Patient who has received an organ transplant (apart from a corneal transplant)

- Patient who has received an autograft or hematopoietic marrow allograft

- Unstable or poorly controlled disease, acute or chronic, not related to GCA and
considered by the investigator as a contraindication to ustekinumab treatment
(examples: recurrent infections, ulcers of the lower limbs poorly controlled, unstable
ischemic cardiovascular disease, terminal renal failure, liver failure, heart failure
= stage III/IV NYHA, diabetes poorly controlled...).

- Other treatments :

- Patient who has received at least 3 systemic corticoid cures for a condition
other than GCA within the last 6 months (dermocorticoids and inhaled corticoids
are allowed)

- Patient receiving long-term corticosteroid treatment (excluding dermocorticoids
and inhaled corticosteroids) for a condition other than GCA

- Patient currently treated or having received, within 4 weeks, cytotoxic,
immunosuppressive (except methotrexate and azathioprine which should however be
stopped before inclusion), immunomodulatory (except dapsone which should however
be stopped before inclusion) or biotherapic treatment.

- Live vaccine injected within 30 days of inclusion

Infections :

- Chronic (or acute) viral hepatitis B or C

- HIV infection

- Persistent infection or severe infection requiring hospitalization or intravenous
antibiotic treatment within 30 days of inclusion (trial antibiotics, regardless of
duration and route of administration, are not an exclusion criterion).

- Infection requiring oral antibiotic treatment within 14 days of inclusion (trial
antibiotics, regardless of duration and route of administration, are not an exclusion
criterion).

- History of histoplasmosis or listeriosis

- Active tuberculosis

- Sign of latent tuberculosis (based on a history of untreated contagion, an opacity
greater than 1 cm in diameter on chest X-ray, or a positive in vitro test
[QuantiferonR or T-spot-TBR]). A history of tuberculosis disease or latent
tuberculosis whose treatment has been completed and which has been properly conducted
does not constitute an exclusion criterion, regardless of the outcome of the
QuantiferonR or T-spot-TBR.



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Patients Relapsing Refractory Giant Cell Arteritis

Intervention(s)

Drug: prednisone and ustekinumab treatment

Other: questionnaires

Biological: Blood samples

Drug: prednisone treatment

Primary Outcome(s)

Percentage of living patients who went into remission after inclusion, without a new relapse and without deviation from the prednisone tapering protocol planned in the study. [Time Frame: Week 52]

Secondary ID(s)

SAMSON PHRC I 2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors