Could an arthritis drug tame giant cell arteritis?

NCT ID NCT02902731

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding anakinra, an anti-inflammatory drug, to standard steroid treatment could lower relapse rates in people with giant cell arteritis, a blood vessel disease. The trial planned to include 70 adults over 50 but was stopped early with only 30 participants. Researchers compared daily injections of anakinra or a placebo alongside steroids for 16 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
anakinra (a drug that blocks inflammation)
What this could lead to
If it works, this could offer a way to reduce steroid use and prevent relapses in giant cell arteritis.
What could go wrong
The trial was terminated early and enrolled only 30 people, so results are limited. Anakinra may not work better than steroids alone and requires daily injections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

30 people

The number who actually took part.

Started

May 2017

Finished

Nov 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

51 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 cardiovascular risk patients with diabetes are defined by: \- A kidney disorder (proteinuria\> 300mg / 24h or creatinine clearance \<60mL / min according to Cockroft) \- Or at least two of the following risk factors: \- Men over 50 years, over 60 year old woman * History of premature coronary disease: myocardial infarction or sudden death in the father or relative in the first degree male before age 55 and before age 65 for females * Current or quit smoking for less than 3 years * High blood pressure treated or not * HDL cholesterol \<0.40 g / L regardless of sex * Microalbuminuria (\> 30 mg / 24h) NB: The moderate renal impairment (clearance ≥ 30 mL / min and \<50 mL / min) is not here a criterion for non-inclusion, but the appropriate injection KINERET (anakinra) provided daily will be made every two days.

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Conditions

The condition(s) this trial relates to.

Giant Cell Arteritis temporal arteritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Pr Aouba

    Caen, 14000, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.