Bullous PemphigoidPhase 3BP/MTXNCT02313870
Topical Steroids Alone or Associated With Methotrexate in Bullous Pemphigoid
A Phase 3 study testing clobetasol propionate + Methotrexate and clobetasol propionate alone in people with Bullous Pemphigoid, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- clobetasol propionate + Methotrexate and clobetasol propionate alone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2008to 31 Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years old or more
- Patients affiliated to social security system,
- Bullous pemphigoid diagnosed according to the following criteria: presence of at least 3 of the 4 clinical criteria for bullous pemphigoid as published by the french group for study of blistering diseases (positive predictive value: 95 %: age over 70 years, no lesions on neck or head, absence of atrophic scars, no mucosal lesions.= Histological Examination consistent with BP diagnosis and carried out in the month before inclusion: existence of a sub epidermal blister regardless of its size, containing neutrophils and / or eosinophils associated with a dermal infiltrate consisting of neutrophils and / or eosinophils, or to margination of neutrophils and / or eosinophils along the dermoepidermal junction.= Direct immunofluorescence performed (DIF) in the month preceding inclusion and showing linear deposition of IgG and / or C3 along the dermo-epidermal junction.
- Patients: = no prior topical steroid or superpotent topical steroids for less than 16 days using the same or equivalent dosage as the one used in the study a different regimen and this regardless of the clinical resultsOR receiving potent or superpotent topical steroids for at least 16 days with a different regimen than that used during the trial AND not controlled by this treatment (appearance of at least 3 new blisters per day)
- written consent of the patient or, if not possible, certified by a third party,
- effective contraception (oral or intrauterine device) set up at least one month before inclusion for women of childbearing age,
- For women of reproductive age (age <50 years), negative serum pregnancy test at inclusion
- Serum albumin ≥ 25 g / L
Who cannot join
- Localized bullous pemphigoid (area <400 cm2: 20 x 20 cm)
- Major blood cytopenia: Hb ≤ 10 g / dl and / or leukocytes ≤ 3000 / mm3 and / or platelets ≤ 100,000 / mm3
- Creatinine Clearance appreciated by the formula MDRD <30 ml / min
- Serum albumin <25 g / L
- pregnancy-associated Pemphigoid
- Linear IgA Dermatosis identified by DIF
Show all 24Show fewer
- Pemphigoid with clinically dominant mucosal lesions
- Relapse of previously diagnosed pemphigoid and still receiving treatment or for whom treatment was stopped for less than six months
- Known allergy to topical steroids and / or methotrexate
- recent history of liver disease (within two years) regardless of its nature or presence of active liver disease (transaminases and / or alkaline phosphatase greater than twice the upper standard laboratory)
- Chronic alcoholism (declared consumption of more than 60 g alcohol / day or approximately 0.5 L / day of wine)
- patient receiving notoriously hepatotoxic drugs or that can interfere with metabolism or haematological toxicity of Methotrexate
- Peptic ulcer proven by endoscopy performed during the last 15 days
- Severe Active infection regardless of its nature
- Evolutive neoplasia whatever its nature except basal cell carcinoma
- Poorly controlled diabetes mellitus (fasting glucose greater than or equal to 2 2.5 g / L and / or Hb A1C greater than or equal to 8.5% before treatment)
- disease that can not be possibly monitored on a regular basis
- acquired or congénital Immunosuppression
- known HIV Seropositivity
- Chronic respiratory failure
- Pregnancy or breastfeeding
- Patient of childbearing age and not using effective contraception
- Patient incapable of giving informed consent and for whom a family member or a trustworthy third party does not grant participation in the study, protected adults, vulnerable people (art. L1121-6, L1121-7, L 1121-8, L1121-9) or patient accrued in another clinical research study
- Long-term treatment prescribed for another illness by steroids, immunosuppressive drugs, cyclosporin or any other treatment that may have been successfully used in the treatment of bullous pemphigoid (dapsone, Gamma globulins, plasma exchange, tetracyclines). For all previous medications, a minimum clearance of two months is required before enrollment in the present trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Monotherapy With Protracted Superpotent Topical Steroids to Superpotent Topical Steroids Associated With Methotrexate in Bullous Pemphigoid
This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months (current standard of care). The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.
Read the detailed description
Bullous pemphigoid (BP) is a rare mucocutaneous autoimmune bullous disorder (incidence <1/10000 / year in France) that mostly affects elderly patients. Its mortality rate is as high as 20 to 40% at one year. A study initiated by the French group for bulllous disorders devoted to the study of autoimmune bullous diseases the study of autoimmune bullous diseases and which is an international leader on this issue, has previously demonstrated the efficacy and relatively good tolerance of superpotent topical corticosteroids in BP.However, the use of superpotent topical corticosteroids is flawed with practical difficulties (home-based care by nurses once or twice a day to administer treatment, this for several months) and its cost is significantly higher than that an oral steroid treatment as a consequence. On the other hand, there is probably a non-negligible systemic absorption of superpotent topicalsteroid responsible for potentially serious side effects similar to those encountered with systemic corticosteroids. Finally, a protracted treatment with superpotent topical steroid most often causes skin atrophy with deleterious consequences.It would then be of interest to be able to significantly reduce the duration of use of topical steroids through an early-associated systemic treatment relying on an easy-to-use and relatively safe molecule that would maintain the disease under control after an initial clinical remission has been achieved by initial and time-limited use of superpotent topical steroids. Methotrexate (MTX) could be an interesting candidate in this regard, with a low-level and tolerable short- and middle-term toxicity if small doses are used (10-15 mg / week) while its long-term safety is usually irrelevant in elderly patients. Its use and monitoring are relatively easy and a number of international publications, including two recent French ones, have shown efficacy in this setting including a relaying strategy after initial use of superpotent topical steroids in BP treatment, in preliminary open studies .These encouraging results prompt to propose a controlled multi-center randomized clinical trial, with direct individual benefit, comparing efficacy and safety of a treatment regimen using superpotent topical steroids alone maintained 9 months (current standard of care) to a mixed initial treatment combining applications of superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 additional months in non-localized BP. In both arms, the total treatment duration will then be 9 months. The two arms of the study will be:Arm A: daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, associated with methotrexate (MTX) received either orally or subcutaneously at a dose of 12.5 mg / week in patients weighing less than 60 kg and with creatinine clearance greater than 50 ml / min (planned dose reduction to 10 mg / week in patients less than 60 kg or with a creatinine clearance less than 50 ml / min) for four weeks followed by oral or subcutaneous methotrexate alone at the same dose during following 8 monthsArm B: daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day maintained until 14 days after full disease control followed by the same daily dose applied every other day for a month and then twice a week for a month and then once a week until the end of the 9th month.The primary endpoint will be the actuarial survival rate at one year in both groups and secondary endpoints will be the initial control rate of the disease, the number of serious side effects during treatment and the number of relapses during treatment.The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.This study will enroll 150 patients per arm and will include a follow up of 9 months with 9 visits per patient.
- Conditions
- Bullous Pemphigoid
- Being tested
- clobetasol propionate + Methotrexate, clobetasol propionate alone
- Keywords
- Bullous pemphigoid, superpotent topical steroids, methotrexate, safety
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clobetasol propionate + MethotrexateDrug
daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, associated with methotrexate (MTX) received either orally or subcutaneously at a dose of 12.5 mg / week in patients weighing less than 60 kg and with creatinine clearance greater than 50 ml / min (planned dose reduction to 10 mg / week in patients less than 60 kg or with a creatinine clearance less than 50 ml / min) for four weeks followed by oral or subcutaneous methotrexate alone at the same dose during following 8 months
clobetasol propionate aloneDrug
daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, up to 14 days after control of the disease followed by 1 application every 2 days at the same dose for 4 weeks then an application twice a week for 4 weeks then once application a week until the end of the 9th month of treatment
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Superpotent topical steroids/methotrexate Receives: Drug: clobetasol propionate + Methotrexate |
| B | Other | Superpotent topical steroids (clobetasol propionate) Receives: Drug: clobetasol propionate alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
actuarial survival
The primary endpoint is the actuarial survival rate with or without recurrence at 9 months in the topical steroid + methotrexate group (Arm A) compared to exclusive topical steroid group (Arm B).
Measured: 9 months
Secondary outcomes (5)
Initial control rate of the disease
The initial control rate of the disease at D28 (Visit 4)
Measured: 9 months
Safety: The frequency of serious and significant adverse events
Measured: 9 months
Frequency of relapses
The frequency of relapses during treatment
Measured: 9 months
Relapse-free survival
relapse-free survival
Measured: 9 months
Easiness of use
Easiness of use indirectly estimated by treatment complicance evaluation
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study start22 Jan 2008
- Primary completion26 May 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- None (open label)
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Dereure, MD, PhD, Principal investigator, University of Montpellier France; French Society of Dermatology; french group for study of blistering diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313870
- Sponsor's protocol ID
- 7850
- Acronym
- BP/MTX
- Status last verified
- Jan 2022
- First submitted
- 8 Dec 2014
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Dereure O, Bernard P, Chosidow O, Ingen-Housz-Oro S, Machet L, Duvert-Lehembre S, Maillard H, Abasq C, Sassolas B, Acquitter M, Konstantinou MP, Chaby G, Caux F, Le Roux-Villet C, Prost C, Avenel-Audran M, Delaporte E, Jeudy G, Mahe A, Montaudie H, Picard-Dahan C, Quereux G, Richard MA, Bourgault-Villada I, Jullien D, Lepelletier C, Fichel F, Sanchez M, Rouanet J, Labeille B, Mahe E, Pham-Ledard A, Herman F, Picot MC, Joly P. Combined methotrexate and short-term superpotent topical corticosteroids compared with prolonged superpotent topical corticosteroids alone in bullous pemphigoid: a multicentre, noninferiority randomised clinical trial. Br J Dermatol. 2026 Mar 10:ljag094. doi: 10.1093/bjd/ljag094. Online ahead of print.
PubMed 41807108
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Monotherapy With Protracted Superpotent Topical Steroids to Superpotent Topical Steroids Associated With Methotrexate in Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT02313870
- Acronym / sponsor ID
- BP/MTX / 7850
- Conditions
- Bullous Pemphigoid
- Keywords
- Bullous pemphigoid, superpotent topical steroids, methotrexate, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 22 Jan 2008 (actual)
- Primary completion
- 26 May 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 10 Dec 2014 (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.
This controlled multi-center randomized clinical trial, with direct individual benefit, will compare efficacy and safety of two strategies in non-localized BP care: a combined regimen using initial superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 months and superpotent topical steroids alone maintained 9 months (current standard of care). The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.
Detailed description
Bullous pemphigoid (BP) is a rare mucocutaneous autoimmune bullous disorder (incidence <1/10000 / year in France) that mostly affects elderly patients. Its mortality rate is as high as 20 to 40% at one year. A study initiated by the French group for bulllous disorders devoted to the study of autoimmune bullous diseases the study of autoimmune bullous diseases and which is an international leader on this issue, has previously demonstrated the efficacy and relatively good tolerance of superpotent topical corticosteroids in BP.However, the use of superpotent topical corticosteroids is flawed with practical difficulties (home-based care by nurses once or twice a day to administer treatment, this for several months) and its cost is significantly higher than that an oral steroid treatment as a consequence. On the other hand, there is probably a non-negligible systemic absorption of superpotent topicalsteroid responsible for potentially serious side effects similar to those encountered with systemic corticosteroids. Finally, a protracted treatment with superpotent topical steroid most often causes skin atrophy with deleterious consequences.It would then be of interest to be able to significantly reduce the duration of use of topical steroids through an early-associated systemic treatment relying on an easy-to-use and relatively safe molecule that would maintain the disease under control after an initial clinical remission has been achieved by initial and time-limited use of superpotent topical steroids. Methotrexate (MTX) could be an interesting candidate in this regard, with a low-level and tolerable short- and middle-term toxicity if small doses are used (10-15 mg / week) while its long-term safety is usually irrelevant in elderly patients. Its use and monitoring are relatively easy and a number of international publications, including two recent French ones, have shown efficacy in this setting including a relaying strategy after initial use of superpotent topical steroids in BP treatment, in preliminary open studies .These encouraging results prompt to propose a controlled multi-center randomized clinical trial, with direct individual benefit, comparing efficacy and safety of a treatment regimen using superpotent topical steroids alone maintained 9 months (current standard of care) to a mixed initial treatment combining applications of superpotent topical steroids associated with methotrexate for 4 weeks followed by methotrexate alone for 8 additional months in non-localized BP. In both arms, the total treatment duration will then be 9 months. The two arms of the study will be:Arm A: daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, associated with methotrexate (MTX) received either orally or subcutaneously at a dose of 12.5 mg / week in patients weighing less than 60 kg and with creatinine clearance greater than 50 ml / min (planned dose reduction to 10 mg / week in patients less than 60 kg or with a creatinine clearance less than 50 ml / min) for four weeks followed by oral or subcutaneous methotrexate alone at the same dose during following 8 monthsArm B: daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day maintained until 14 days after full disease control followed by the same daily dose applied every other day for a month and then twice a week for a month and then once a week until the end of the 9th month.The primary endpoint will be the actuarial survival rate at one year in both groups and secondary endpoints will be the initial control rate of the disease, the number of serious side effects during treatment and the number of relapses during treatment.The expected result is an equivalence between the two compared strategies in terms of safety and efficacy, MTX monotherapy during the maintenance phase being easier to manage and therefore associated with better compliance than topical steroids with less cutaneous side effects and most cost-effective.This study will enroll 150 patients per arm and will include a follow up of 9 months with 9 visits per patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: clobetasol propionate + MethotrexateSuperpotent topical steroids/methotrexate |
| B | Other | Drug: clobetasol propionate aloneSuperpotent topical steroids (clobetasol propionate) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects aged 18 years old or more
- Patients affiliated to social security system,
- Bullous pemphigoid diagnosed according to the following criteria: presence of at least 3 of the 4 clinical criteria for bullous pemphigoid as published by the french group for study of blistering diseases (positive predictive value: 95 %: age over 70 years, no lesions on neck or head, absence of atrophic scars, no mucosal lesions.= Histological Examination consistent with BP diagnosis and carried out in the month before inclusion: existence of a sub epidermal blister regardless of its size, containing neutrophils and / or eosinophils associated with a dermal infiltrate consisting of neutrophils and / or eosinophils, or to margination of neutrophils and / or eosinophils along the dermoepidermal junction.= Direct immunofluorescence performed (DIF) in the month preceding inclusion and showing linear deposition of IgG and / or C3 along the dermo-epidermal junction.
- Patients: = no prior topical steroid or superpotent topical steroids for less than 16 days using the same or equivalent dosage as the one used in the study a different regimen and this regardless of the clinical resultsOR receiving potent or superpotent topical steroids for at least 16 days with a different regimen than that used during the trial AND not controlled by this treatment (appearance of at least 3 new blisters per day)
- written consent of the patient or, if not possible, certified by a third party,
Key exclusion criteria (24 listed)
- Localized bullous pemphigoid (area <400 cm2: 20 x 20 cm)
- Major blood cytopenia: Hb ≤ 10 g / dl and / or leukocytes ≤ 3000 / mm3 and / or platelets ≤ 100,000 / mm3
- Creatinine Clearance appreciated by the formula MDRD <30 ml / min
- Serum albumin <25 g / L
- pregnancy-associated Pemphigoid
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 |
|---|---|---|
| clobetasol propionate + Methotrexatedaily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, associated with methotrexate (MTX) received either orally or subcutaneously at a dose of 12.5 mg / week in patients weighing less than 60 kg and with creatinine clearance greater than 50 ml / min (planned dose reduction to 10 mg / week in patients less than 60 kg or with a creatinine clearance less than 50 ml / min) for four weeks followed by oral or subcutaneous methotrexate alone at the same dose during following 8 months | Drug | A |
| clobetasol propionate alonedaily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, up to 14 days after control of the disease followed by 1 application every 2 days at the same dose for 4 weeks then an application twice a week for 4 weeks then once application a week until the end of the 9th month of treatment | Drug | B |
Primary outcome
actuarial survival
Time frame: 9 months
The primary endpoint is the actuarial survival rate with or without recurrence at 9 months in the topical steroid + methotrexate group (Arm A) compared to exclusive topical steroid group (Arm B).
5 secondary outcomes
Initial control rate of the disease
Time frame: 9 months
Safety: The frequency of serious and significant adverse events
Time frame: 9 months
Frequency of relapses
Time frame: 9 months
Relapse-free survival
Time frame: 9 months
Easiness of use
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Results publication: PubMed 41807108Dereure O, Bernard P, Chosidow O, Ingen-Housz-Oro S, Machet L, Duvert-Lehembre S, Maillard H, Abasq C, Sassolas B, Acquitter M, Konstantinou MP, Chaby G, Caux F, Le Roux-Villet C, Prost C, Avenel-Audran M, Delaporte E, Jeudy G, Mahe A, Montaudie H, Picard-Dahan C, Quereux G, Richard MA, Bourgault-Villada I, Jullien D, Lepelletier C, Fichel F, Sanchez M, Rouanet J, Labeille B, Mahe E, Pham-Ledard A, Herman F, Picot MC, Joly P. Combined methotrexate and short-term superpotent topical corticosteroids compared with prolonged superpotent topical corticosteroids alone in bullous pemphigoid: a multicentre, noninferiority randomised clinical trial. Br J Dermatol. 2026 Mar 10:ljag094. doi: 10.1093/bjd/ljag094. Online ahead of print.
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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.
Olivier Dereure, MD, PhD principal investigator
University of Montpellier France; French Society of Dermatology; french group for study of blistering diseases
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 clobetasol propionate + Methotrexate and clobetasol propionate alone in people with Bullous Pemphigoid, run by University Hospital, Montpellier 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 8 inclusion and 24 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: finished, as of the sponsor's last update on 24 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
actuarial survival (time frame: 9 months). 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 NCT02313870, which also lists 1 linked publication.
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 24 Apr 2026.