NeuroEndocrine TumoursPhase 4CALM-NETNCT02075606

Circulating Tumour Cells in Somatuline Autogel Treated NeuroEndocrine Tumours Patients

A Phase 4 study testing lanreotide acetate in people with NeuroEndocrine Tumours, run by Ipsen at 14 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: NeuroEndocrine Tumours
What is being tested?: lanreotide acetate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 14 sitesUnited Kingdom
Study dates: May 2014to Jun 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Provision of written informed consent prior to any study related procedures.
Patients (either sex) must be 18 years or older.
Patients must be suffering from symptoms of diarrhoea and/or flushing at the time of study enrolment.
Patients must have a documented diagnosis of a functioning midgut NET.
In order to avoid patients with rapidly progressing tumours, only patients with well or moderately differentiated tumours and with a Ki67 proliferation index of <20% will be recruited.
The clinically appropriate treatment for the patient must be therapy with a somatostatin analogue.
Patients must have had either a positive somatostatin receptor scintigraphy result or a positive 68Gallium-DOTATATE PET imaging result.

Who cannot join

If the patient is at risk of pregnancy or is breast feeding, unless treatment with Somatuline Autogel is clearly needed (as determined by the clinician).
The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
The patient has been treated with any other unlicensed drug within the last 30 days before study entry or will require a concurrent treatment with any other experimental drugs or treatments.
The patient has been treated with a somatostatin analogue prior to study entry, unless a washout period of at least 2 weeks for subcutaneous octreotide, or at least 6 weeks for a single dose of long acting somatostatin analogue has occurred.
The patient has received interferon, chemotherapy, chemoembolisation or radionuclide therapy within 3 months prior to study entry.
The patient has a history of hypersensitivity to drugs with a similar chemical structure.
Females of childbearing potential must be using oral, double barrier or injectable contraception. Non childbearing potential is defined as being post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study.
The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardise the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United Kingdom14 sites

Basingstoke & North Hampshire Hospital
Basingstoke
Queen Elizabeth Hospital
Birmingham
University Hospital Wales
Cardiff
Beatson West of Scotland Cancer Centre
Glasgow
St James's University Hospital
Leeds
University Hospital Aintree
Liverpool
Hammersmith Hospital
London
King's College Hospital
London
Royal Free Hospital
London
Maidstone Hospital
Maidstone
The Christie Hospital
Manchester
Norfolk & Norwich Hospital
Norwich
Royal Hallamshire Hospital
Sheffield
Southampton University Hospital
Southampton

Other trials in United Kingdom

About this study

Official title: A Phase IV, Multicentre, Open Label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients Receiving Deep Subcutaneous Administrations of Somatuline® (Lanreotide) Autogel® to Treat the Symptoms of Functioning Midgut NeuroEndocrine Tumours (NET)

Circulating tumour cells (CTCs) are detectable in the blood in around 50% of patients with functioning NeuroEndocrine Tumours (NET) arising in the midgut area (tumours which are secreting hormones and are located in the area in the middle of the digestive system) and their presence usually means that the prognosis for the patient is poor. CTCs have also been shown to be valuable as predictive markers following treatment and there is increasing interest in using CTCs as 'liquid biopsies' that can help to inform treatment decisions. CTC analysis has the benefit of being relatively non- invasive and quick compared with a conventional CT scan and is therefore an attractive method of monitoring the tumour throughout the treatment period.

The purpose of this study is to assess the clinical value that enumeration will have in predicting the clinical symptomatic response and progression free survival in patients receiving Somatuline Autogel for functioning midgut NETs over a one year period.

Conditions: NeuroEndocrine Tumours
Being tested: lanreotide acetate
Keywords: NET, Symptomatic response, Functioning NeuroEndocrine Tumours, midgut region
Medical subject headings: Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lanreotide acetateDrug
Somatuline Autogel injection 120mg for first 3 months then 120, 90 or 60 mg administered via the deep subcutaneous route every 28 days

Study groups in NCT02075606
Study group	Role	What they receive
Somatuline Autogel®	Experimental	Somatuline Autogel® to treat Functioning Midgut NeuroEndocrine Tumours (NET) Receives: Drug: lanreotide acetate

What is being measured

The primary outcome is the main question the study is designed to answer.

Assessment of Clinical Symptomatic Response
This endpoint was assessed using 2 efficacy variables:
- CTCs, enumerated at baseline and Weeks 5, 17, 25, 53
- Clinical symptomatic response, assessed by the use of symptom reporting
Subjects recorded 24-hour symptom frequency and severity for 7 days prior to first treatment (baseline), throughout the study, and up to 28 days following final drug administration. Symptoms were recorded by answering predetermined questions on the interactive voice response system (IVRS).
Subjects were considered to have a clinical symptomatic response between baseline and last study visit if any 1 of the following criteria were fulfilled: the average number of episodes of diarrhoea decreased by at least 50%, the average number of episodes of flushing decreased by at least 50%, the mode severity of flushing decreased by at least 1 level. Clinical symptomatic response was assessed as a qualitative variable (Yes/No) and reported according to CTC presence at baseline and overall.
Measured: From baseline up to Week 53.
Percentage of Subjects With Time Point Responses According to Response Evaluation Criteria in Solid Tumours (RECIST) Assessments at Weeks 25 and 53
Subjects underwent Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans at baseline, Visit 8 (Week 25) and Visit 15 (Week 53). Progression was assessed by investigators using RECIST v1.1, and classified as a complete response, partial response, stable disease, progressive disease or non evaluable.
The time point responses at Week 25 and Week 53 were analysed by CTC presence at baseline and overall. The percentage of subjects within each response category are presented. Percentages are based on the number of subjects in the concerned population with available responses.
Measured: Week 25 and Week 53.

Secondary outcomes (5)

Mean Change From Baseline in Number of Episodes of Diarrhoea and Flushing
The effect of lanreotide Autogel on the symptoms of diarrhoea and flushing in subjects was assessed through subject reporting of symptoms every 24-hours for the 7 days prior to treatment (baseline), for the first 16 weeks and on days 11 to 17 after each subsequent injection interval. After the final study drug injection at Week 49, subjects provided 24-hour symptom frequency on days 11 to 28 (up to Week 53). Symptom frequency was recorded by answering predetermined questions on the IVRS.
Mean change from baseline in frequency (number of episodes) of diarrhoea and flushing are described at Visit 2 (average number of episodes in Week 1) and at Visit 14 (average number of episodes over days 11 to 17 after Week 49 injection and over days 11 to 28 after Week 49 injection) by CTC presence at baseline and overall. A negative change indicates an improvement in symptoms from baseline.
Measured: From baseline up to Week 53.
Mode Symptom Severity of Episodes of Flushing
The effect of lanreotide Autogel on the mode severity of flushing was assessed through subject reporting of symptoms every 24-hours for the 7 days prior to treatment (baseline), for the first 16 weeks and on days 11 to 17 after each subsequent injection interval until Week 49. After the final study drug injection at Week 49, subjects provided 24-hour symptom severity on days 11 to 28 (up to Week 53). Symptom severity was recorded by answering predetermined questions on the IVRS using a three-point system (mild, moderate or severe). The mode (most frequent) intensity of flushing are reported at baseline and at Visit 14 (average number of episodes over days 11 to 17 after Week 49 injection and over days 11 to 28 after Week 49 injection). Percentages of subjects in each severity category are based on the number of subjects in the analysis set with available responses. Data is presented according to CTC presence at baseline and overall.
Measured: From baseline up to Week 53.
Quality of Life (QoL) Questionnaire: European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire (QLQ)-C30
The effect of lanreotide Autogel treatment on QoL was assessed using the EORTC QLQ-C30 at baseline, Weeks 13 (Visit 5), 25 (Visit 8) and 53 (Visit 15/end of study). The 30 item scale is divided into 9 multi item scales (including 5 functional scales, 1 global health status/QoL scale and 3 general symptom scales) and 6 single items. Possible answers to the first 28 items (all items except the 2 concerning global quality of life) go from 1 (Not at all) to 4 (Very much). The answers for the 2 last questions (Q29- 30) go from 1 (Very poor) to 7 (Excellent). All of the scales and single-item measures range in score from 0 to 100. For multi-item scales, the raw score will be calculated by the addition of item responses divided by the number of items. Higher scores for global health and functional domains indicate a better QoL, while higher symptom scores indicate worse symptoms.
The mean change from baseline at each time point is reported for each of the category subscores.
Measured: From baseline up to Week 53.
QoL Questionnaire: EORTC QLQ-G.I.NET21
The effect of lanreotide Autogel treatment on QoL was assessed using the EORTC QLQ-G.I.NET21 at baseline, Weeks 13 (Visit 5), 25 (Visit 8) and 53 (Visit 15/end of study). The QLQ-G.I.NET21 questionnaire contained 21 questions that used a 4-point scale (1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much) to evaluate 3 defined multi-item symptom scales (endocrine, gastrointestinal and treatment related side effects), 2 single item symptoms (bone/muscle pain and concern about weight loss), 2 psychosocial scales (social function and disease-related worries) and 2 other single items (sexuality and communication). Each individual subscore was transformed to range from 0 to 100. Higher scores indicate worse symptoms or more problems. The mean change from baseline at each time point is reported for each of the category subscores.
Measured: From baseline up to Week 53.
Percentage of Subjects Alive and Progression Free at One Year
Subjects underwent CT or MRI scans at baseline and Week 53. Progression was assessed by investigators using RECIST v1.1. The best overall response to study treatment is the highest time point response achieved by the subject and was assessed as a complete response, partial response, stable disease, progressive disease or non evaluable. For analysis of PFS, event dates were assigned to the first time that progressive disease was noted or the date of death. In case of progressive disease followed by death, the first event was considered in the analysis. Censoring dates were defined in subjects with no progressive disease or death before end of study.
At one year (end of study), the mean percentage of subjects who were alive and progression free, as calculated using the Kaplan-Meier method, is reported by CTC presence and overall.
Measured: From baseline up to Week 53.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014Jun 2017

First posted3 Mar 2014 (estimated)
Study startMay 2014
Primary completionJun 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for NeuroEndocrine TumoursStudies of the same condition, open and under way.
More trials run by IpsenThe 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 4
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02075606
Sponsor's protocol ID: A-97-52030-270
Other IDs: 2013-002194-22
Acronym: CALM-NET
Status last verified: Feb 2019
First submitted: 26 Feb 2014
Last updated: 7 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Meyer T, Caplin M, Khan MS, Toumpanakis C, Shetty S, Ramage JK, Houchard A, Higgs K, Shah T. Circulating tumour cells and tumour biomarkers in functional midgut neuroendocrine tumours. J Neuroendocrinol. 2022 Apr;34(4):e13096. doi: 10.1111/jne.13096. Epub 2022 Feb 7.
PubMed 35132704
Childs A, Vesely C, Ensell L, Lowe H, Luong TV, Caplin ME, Toumpanakis C, Thirlwell C, Hartley JA, Meyer T. Expression of somatostatin receptors 2 and 5 in circulating tumour cells from patients with neuroendocrine tumours. Br J Cancer. 2016 Dec 6;115(12):1540-1547. doi: 10.1038/bjc.2016.377. Epub 2016 Nov 22.
PubMed 27875519

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Multicentre, Open Label, Single Group Exploratory Study to Assess the Clinical Value of Enumeration of Circulating Tumour Cells (CTCs) to Predict Clinical Symptomatic Response and Progression Free Survival in Patients Receiving Deep Subcutaneous Administrations of Somatuline® (Lanreotide) Autogel® to Treat the Symptoms of Functioning Midgut NeuroEndocrine Tumours (NET)
ClinicalTrials.gov ID: NCT02075606
Acronym / sponsor ID: CALM-NET / A-97-52030-270
Conditions: NeuroEndocrine Tumours
Keywords: NET, Symptomatic response, Functioning NeuroEndocrine Tumours, midgut region
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: IpsenIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: Jun 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 3 Mar 2014 (estimated)
Results: Posted 7 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Somatuline Autogel®	Experimental	Drug: lanreotide acetateSomatuline Autogel® to treat Functioning Midgut NeuroEndocrine Tumours (NET)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Provision of written informed consent prior to any study related procedures.
Patients (either sex) must be 18 years or older.
Patients must be suffering from symptoms of diarrhoea and/or flushing at the time of study enrolment.
Patients must have a documented diagnosis of a functioning midgut NET.
In order to avoid patients with rapidly progressing tumours, only patients with well or moderately differentiated tumours and with a Ki67 proliferation index of <20% will be recruited.

Key exclusion criteria (8 listed)

If the patient is at risk of pregnancy or is breast feeding, unless treatment with Somatuline Autogel is clearly needed (as determined by the clinician).
The patient is, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions, or present any concomitant condition which could compromise the objectives of the study and/or preclude the protocol-defined procedures (e.g. severe medical conditions, brain metastases, psychiatric disorders, active or uncontrolled infection, known pituitary disease).
The patient has been treated with any other unlicensed drug within the last 30 days before study entry or will require a concurrent treatment with any other experimental drugs or treatments.
The patient has been treated with a somatostatin analogue prior to study entry, unless a washout period of at least 2 weeks for subcutaneous octreotide, or at least 6 weeks for a single dose of long acting somatostatin analogue has occurred.
The patient has received interferon, chemotherapy, chemoembolisation or radionuclide therapy within 3 months prior to study entry.

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
lanreotide acetateSomatuline Autogel injection 120mg for first 3 months then 120, 90 or 60 mg administered via the deep subcutaneous route every 28 days	Drug	Somatuline Autogel®

Primary outcome

Assessment of Clinical Symptomatic Response
Time frame: From baseline up to Week 53.
This endpoint was assessed using 2 efficacy variables: * CTCs, enumerated at baseline and Weeks 5, 17, 25, 53 * Clinical symptomatic response, assessed by the use of symptom reporting Subjects recorded 24-hour symptom frequency and severity for 7 days prior to first treatment (baseline), throughout the study, and up to 28 days following final drug administration. Symptoms were recorded by answering predetermined questions on the interactive voice response system (IVRS). Subjects were considered to have a clinical symptomatic response between baseline and last study visit if any 1 of the following criteria were fulfilled: the average number of episodes of diarrhoea decreased by at least 50%, the average number of episodes of flushing decreased by at least 50%, the mode severity of flushing decreased by at least 1 level. Clinical symptomatic response was assessed as a qualitative variable (Yes/No) and reported according to CTC presence at baseline and overall.
Percentage of Subjects With Time Point Responses According to Response Evaluation Criteria in Solid Tumours (RECIST) Assessments at Weeks 25 and 53
Time frame: Week 25 and Week 53.
Subjects underwent Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scans at baseline, Visit 8 (Week 25) and Visit 15 (Week 53). Progression was assessed by investigators using RECIST v1.1, and classified as a complete response, partial response, stable disease, progressive disease or non evaluable. The time point responses at Week 25 and Week 53 were analysed by CTC presence at baseline and overall. The percentage of subjects within each response category are presented. Percentages are based on the number of subjects in the concerned population with available responses.

5 secondary outcomes

Mean Change From Baseline in Number of Episodes of Diarrhoea and Flushing
Time frame: From baseline up to Week 53.
Mode Symptom Severity of Episodes of Flushing
Time frame: From baseline up to Week 53.
Quality of Life (QoL) Questionnaire: European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire (QLQ)-C30
Time frame: From baseline up to Week 53.
QoL Questionnaire: EORTC QLQ-G.I.NET21
Time frame: From baseline up to Week 53.
Percentage of Subjects Alive and Progression Free at One Year
Time frame: From baseline up to Week 53.

Results and safety

Results posted to the registry on 7 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lanreotide Autogel	50	40

Primary outcome: Assessment of Clinical Symptomatic Response

Time frame: From baseline up to Week 53.. Number (95% Confidence Interval). Unit: Percentage of Subjects

Measure	CTC Presence at Baseline n = 22	No CTC Presence at Baseline n = 26	Lanreotide Autogel n = 50
Clinical Symptomatic Response = Yes(2)	77.8 (54.8 to 91.0)	95.5 (78.2 to 99.2)	87.5 (73.9 to 94.5)
Clinical Symptomatic Response = No(3)	22.2 (9.0 to 45.2)	4.5 (0.8 to 21.8)	12.5 (5.5 to 26.1)

CTC Presence at Baseline vs No CTC Presence at Baseline: Odds Ratio (OR): 0.17 (95% CI 0.02 to 1.65), p =0.126, Regression, Logistic

Population analysed: Analysis was performed on the Intention-to-treat (ITT) population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis are presented.

Primary outcome: Percentage of Subjects With Time Point Responses According to Response Evaluation Criteria in Solid Tumours (RECIST) Assessments at Weeks 25 and 53

Time frame: Week 25 and Week 53.. Number (95% Confidence Interval). Unit: percentage of subjects

Measure	CTC Presence at Baseline n = 22	No CTC Presence at Baseline n = 26	Lanreotide Autogel n = 50
Week 25: Complete Response	0.0 (0.0 to 25.9)	0.0 (0.0 to 24.2)	0.0 (0.0 to 14.3)
Week 25: Partial Response	18.2 (5.1 to 47.7)	8.3 (1.5 to 35.4)	13.0 (4.5 to 32.1)
Week 25: Stable Disease	72.7 (43.4 to 90.3)	75.0 (46.8 to 91.1)	73.9 (53.5 to 87.5)
Week 25: Progressive Disease	9.1 (1.6 to 37.7)	16.7 (4.7 to 44.8)	13.0 (4.5 to 32.1)
Week 25: Non evaluable	0.0 (0.0 to 25.9)	0.0 (0.0 to 24.2)	0.0 (0.0 to 14.3)
Week 53: Complete Response	0.0 (0.0 to 20.4)	0.0 (0.0 to 14.9)	0.0 (0.0 to 9.4)
Week 53: Partial Response	6.7 (1.2 to 29.8)	4.5 (0.8 to 21.8)	5.4 (1.5 to 17.7)
Week 53: Stable Disease	66.7 (41.7 to 84.8)	63.6 (43.0 to 80.3)	64.9 (48.8 to 78.2)

Population analysed: Analysis was performed on subjects from the ITT population, defined as all enrolled subjects who received at least one injection of study medication. Only subjects with data available for analysis are presented.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline to Week 53 (approximately 1 year).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lanreotide Autogel	12 of 50 (24%)	47 of 50 (94%)	3 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35132704Meyer T, Caplin M, Khan MS, Toumpanakis C, Shetty S, Ramage JK, Houchard A, Higgs K, Shah T. Circulating tumour cells and tumour biomarkers in functional midgut neuroendocrine tumours. J Neuroendocrinol. 2022 Apr;34(4):e13096. doi: 10.1111/jne.13096. Epub 2022 Feb 7.
Derived from this study: PubMed 27875519Childs A, Vesely C, Ensell L, Lowe H, Luong TV, Caplin ME, Toumpanakis C, Thirlwell C, Hartley JA, Meyer T. Expression of somatostatin receptors 2 and 5 in circulating tumour cells from patients with neuroendocrine tumours. Br J Cancer. 2016 Dec 6;115(12):1540-1547. doi: 10.1038/bjc.2016.377. Epub 2016 Nov 22.

Related trials for NeuroEndocrine Tumours

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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.

Matthew Hickling, MD study director

Ipsen

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing lanreotide acetate in people with NeuroEndocrine Tumours, run by Ipsen at 14 sites in United Kingdom.

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 7 inclusion and 8 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 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Assessment of Clinical Symptomatic Response (time frame: From baseline up to Week 53.). The study lists 2 primary outcomes in all. 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 NCT02075606, 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 7 Jun 2019.