Giant Cell ArteritisPhase 3GiAnTNCT02902731
Giant Cell Arteritis and Anakinra Trial
A Phase 3 study testing ANAKINRA in people with Giant Cell Arteritis, run by University Hospital, Caen at 1 site in France.
Trial summary
SYNOPSIS The giant cell arteritis (GCA) is the most frequent vasculitis in people over 50 years. Despite recent progress and physiopathogenic, corticosteroids remains the standard treatment for decades with a very good initial clinical efficacy but a high relapse rate (nearly 40% to 6,5 months) during its decay. Read more about this study
- Who is it for?
- Ages 51 years and older
- Conditions the study is for
- Giant Cell Arteritis
- What is being tested?
- ANAKINRA
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2017to 25 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 51 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 13Show fewer
- 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
Who cannot join
- Subjects checking one of the criteria for non-inclusion may be eligible to participate in the research. These criteria may include:
- 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
Show all 45Show fewer
- 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
- 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
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell Arteritis
SYNOPSIS The giant cell arteritis (GCA) is the most frequent vasculitis in people over 50 years. Despite recent progress and physiopathogenic, corticosteroids remains the standard treatment for decades with a very good initial clinical efficacy but a high relapse rate (nearly 40% to 6,5 months) during its decay. This sensible population is particularly exposed to the side effects of corticosteroids, leading to think about savings strategies. But the association of immunosuppressive therapy and/or anti- TNFα has not demonstrated benefits in terms of efficiency or long-term tolerance to cumulative doses of prednisone. The responsibility of proinflammatory cytokines such as TNFα, IL- 6 and IL-1 has been studied in the pathogenesis of GCA in temporal artery walls and in mouse models. The primary pathogenic role of IL- 1 is based on the increase in serum or nuclear protein itself or that of its mRNA. The study of temporal artery biopsies has shown increased local production of IL- 1β mRNA, IL- 6 and TGFβ (indicative of macrophage activation ) and those of INFɣ and IL 2 (indicative of T lymphocyte activation). Recently, Ly et al (Ly KH JBS 2014) reported the efficacy of anakinra, a recombinant molecule of IL- 1RA specifically blocking the IL- 1 α/β, in three cases GCA refractory to conventional treatments.
Here investigators propose a randomized, multicenter, controlled, double-blind study of anakinra against placebo in addition to corticosteroids in the treatment of GCA.
Read more
This study will include 70 patients randomized equally in both arms: reference treatment (prednisone plus placebo) or the experimental treatment (prednisone + anakinra). Treatment with prednisone will be identical in the two arms, namely a dose of 0.7 mg/kg/day orally on day 1, followed by a progressive decrease in the dose pattern depending on the weight. In the experimental arm, dose of anakinra is the one usually used, ie 100 mg/day by subcutaneous injection from day 1 until the end of week 16 (S16). In the reference arm of the treatment, a placebo anakinra is associated with corticosteroid in the same packaging, duration and respecting the double-blind.
Investigators thus hypothesized that the addition of anakinra to corticosteroid compared to placebo added to the latter, will show a significant decrease in GAC relapse rate. Indeed, the challenge of corticosteroid therapy in this disease is not so much a problem of initial effectiveness, than the adverse events related to relapses and steroid dependence.
Read the detailed description
Side assumptions investigators made are that the patients receiving anakinra in add-on therapy will have: a time and a complete remission rate respectively shorter and higher, fewer relapses and a decrease of the total consumption of prednisone over a 12- month follow-up.
This controlled study is the first to assess the inhibition of the IL- 1 pathway in the GCA with anakinra in add-on therapy with corticosteroids in patients newly diagnosed or on relapse. The purpose of this work is to support the following proof of concept of the addition of anakinra to corticosteroid therapy in the treatment of GCA: potential synergies of this association and intrinsic therapeutic action of anakinra in patient newly diagnosed, and this without loss of opportunity for patients that will benefit all of the reference treatment. The other originality of this study is to demonstrate the steroid-sparing effect of targeting interleukin -1, which is per se a therapeutic and nosologic innovation for this disease. Finally, ancillary biological studies will clarify the mode of action of the anti-cytokine therapy and identify markers of response to this biotherapy.
- Conditions
- Giant Cell Arteritis
- Being tested
- PLACEBO, ANAKINRA
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLACEBODrug
Also called comparative drug
subcutaneous injection of placebo every day during 16 weeks
ANAKINRADrug
subcutaneous injection of anakinra every day during 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | PLACEBO + Usual use of tapering doses of oral prednisone Receives: Drug: PLACEBO |
| anakinra | Experimental | ANAKINRA : dose of anakinra is 100 mg/day by subcutaneous injection from day 1 until the end of week 16 (W16). The dose of Anakinra will be adapted to that recommand according to renal function.
Intervention Anakinra in add on Therapy. Receives: Drug: ANAKINRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
global relapse rate
Measured: Week 26
Secondary outcomes (7)
specific relapse rate
Measured: Week 4 to Week 16
specific relapse rate
Measured: Week 17 to Week 26
specific relapse rate
Measured: W27 to W52
speed efficiency : time of obtaining a complete remission over a follow up of 52 weeks period
Measured: baseline up to 52 weeks
number of first relapse
Measured: baseline up to 52 weeks
cumulative and the average dose of prednisone used
Measured: baseline up to 52 weeks
Safety according CTCAE v4.0
Measured: baseline up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start11 May 2017
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Why it stopped: experimental treatment no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Giant Cell ArteritisStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Achille AOUBA, MD PHD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02902731
- Sponsor's protocol ID
- 2015-005804-27 N° CHU : 15-200
- Other IDs
- 2015
- Acronym
- GiAnT
- Status last verified
- Feb 2023
- First submitted
- 5 Jul 2016
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be planify
Publications
de Boysson H, Ly KH, Geffray L, Quemeneur T, Liozon E, Bezanahary H, Gouellec NL, Audemard A, Dumont A, Deshayes S, Boutemy J, Maigne G, Martin Silva N, Sultan A, Le Mauff B, Petit G, Parienti JJ, Aouba A. Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Res Ther. 2025 Jun 7;27(1):122. doi: 10.1186/s13075-025-03493-z.
PubMed 40483523Sun MM, Pope JE. Polymyalgia rheumatica and giant cell arteritis: diagnosis and management. Curr Opin Rheumatol. 2025 Jan 1;37(1):32-38. doi: 10.1097/BOR.0000000000001059. Epub 2024 Oct 14.
PubMed 39400109
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-blind Study of Anakinra Against Placebo in Addition to Steroids in Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT02902731
- Acronym / sponsor ID
- GiAnT / 2015-005804-27 N° CHU : 15-200
- Conditions
- Giant Cell Arteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: experimental treatment no longer available
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SYNOPSIS The giant cell arteritis (GCA) is the most frequent vasculitis in people over 50 years. Despite recent progress and physiopathogenic, corticosteroids remains the standard treatment for decades with a very good initial clinical efficacy but a high relapse rate (nearly 40% to 6,5 months) during its decay. This sensible population is particularly exposed to the side effects of corticosteroids, leading to think about savings strategies. But the association of immunosuppressive therapy and/or anti- TNFα has not demonstrated benefits in terms of efficiency or long-term tolerance to cumulative doses of prednisone. The responsibility of proinflammatory cytokines such as TNFα, IL- 6 and IL-1 has been studied in the pathogenesis of GCA in temporal artery walls and in mouse models. The primary pathogenic role of IL- 1 is based on the increase in serum or nuclear protein itself or that of its mRNA. The study of temporal artery biopsies has shown increased local production of IL- 1β mRNA, IL- 6 and TGFβ (indicative of macrophage activation ) and those of INFɣ and IL 2 (indicative of T lymphocyte activation). Recently, Ly et al (Ly KH JBS 2014) reported the efficacy of anakinra, a recombinant molecule of IL- 1RA specifically blocking the IL- 1 α/β, in three cases GCA refractory to conventional treatments.
Here investigators propose a randomized, multicenter, controlled, double-blind study of anakinra against placebo in addition to corticosteroids in the treatment of GCA.
This study will include 70 patients randomized equally in both arms: reference treatment (prednisone plus placebo) or the experimental treatment (prednisone + anakinra). Treatment with prednisone will be identical in the two arms, namely a dose of 0.7 mg/kg/day orally on day 1, followed by a progressive decrease in the dose pattern depending on the weight. In the experimental arm, dose of anakinra is the one usually used, ie 100 mg/day by subcutaneous injection from day 1 until the end of week 16 (S16). In the reference arm of the treatment, a placebo anakinra is associated with corticosteroid in the same packaging, duration and respecting the double-blind.
Investigators thus hypothesized that the addition of anakinra to corticosteroid compared to placebo added to the latter, will show a significant decrease in GAC relapse rate. Indeed, the challenge of corticosteroid therapy in this disease is not so much a problem of initial effectiveness, than the adverse events related to relapses and steroid dependence.
Detailed description
Side assumptions investigators made are that the patients receiving anakinra in add-on therapy will have: a time and a complete remission rate respectively shorter and higher, fewer relapses and a decrease of the total consumption of prednisone over a 12- month follow-up.
This controlled study is the first to assess the inhibition of the IL- 1 pathway in the GCA with anakinra in add-on therapy with corticosteroids in patients newly diagnosed or on relapse. The purpose of this work is to support the following proof of concept of the addition of anakinra to corticosteroid therapy in the treatment of GCA: potential synergies of this association and intrinsic therapeutic action of anakinra in patient newly diagnosed, and this without loss of opportunity for patients that will benefit all of the reference treatment. The other originality of this study is to demonstrate the steroid-sparing effect of targeting interleukin -1, which is per se a therapeutic and nosologic innovation for this disease. Finally, ancillary biological studies will clarify the mode of action of the anti-cytokine therapy and identify markers of response to this biotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PLACEBOPLACEBO + Usual use of tapering doses of oral prednisone |
| anakinra | Experimental | Drug: ANAKINRAANAKINRA : dose of anakinra is 100 mg/day by subcutaneous injection from day 1 until the end of week 16 (W16). The dose of Anakinra will be adapted to that recommand according to renal function. Intervention Anakinra in add on Therapy. |
Who may qualify
- Ages
- 51 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
- 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.
Key exclusion criteria (45 listed)
- Subjects checking one of the criteria for non-inclusion may be eligible to participate in the research. These criteria may include:
- pathologies, habitus or other patient characteristics
- Other therapeutic
- Infectious diseases
- Unstable disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLACEBOAlso: comparative drugsubcutaneous injection of placebo every day during 16 weeks | Drug | placebo |
| ANAKINRAsubcutaneous injection of anakinra every day during 16 weeks | Drug | anakinra |
Primary outcome
global relapse rate
Time frame: Week 26
7 secondary outcomes
specific relapse rate
Time frame: Week 4 to Week 16
specific relapse rate
Time frame: Week 17 to Week 26
specific relapse rate
Time frame: W27 to W52
speed efficiency : time of obtaining a complete remission over a follow up of 52 weeks period
Time frame: baseline up to 52 weeks
number of first relapse
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
Results and safety
The study was stopped early (reason given: experimental treatment no longer available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 40483523de Boysson H, Ly KH, Geffray L, Quemeneur T, Liozon E, Bezanahary H, Gouellec NL, Audemard A, Dumont A, Deshayes S, Boutemy J, Maigne G, Martin Silva N, Sultan A, Le Mauff B, Petit G, Parienti JJ, Aouba A. Four months of treatment with anakinra combined with glucocorticoids for giant cell arteritis: a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Res Ther. 2025 Jun 7;27(1):122. doi: 10.1186/s13075-025-03493-z.
- Derived from this study: PubMed 39400109Sun MM, Pope JE. Polymyalgia rheumatica and giant cell arteritis: diagnosis and management. Curr Opin Rheumatol. 2025 Jan 1;37(1):32-38. doi: 10.1097/BOR.0000000000001059. Epub 2024 Oct 14.
- Individual participant dataSharing planned: Undecided. It will be planify
Related trials for Giant Cell Arteritis
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Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
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Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy
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The Applanation Tonometry in GCA Pilot
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Early Temporal Dynamics of Optic Nerve Sheath Diameter After Therapy in GCA
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achille AOUBA, MD PHD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ANAKINRA in people with Giant Cell Arteritis, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: experimental treatment no longer available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
global relapse rate (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02902731, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.