Arthritis, PsoriaticAPOLONCT03096990
A Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium
An observational study of Arthritis, Psoriatic, run by Amgen at 22 sites in Belgium.
Trial summary
The study will include a representative sample of 150 patients with active Psoriatic Arthritis (PsA) for whom the treating rheumatologist has decided to begin treatment with apremilast. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Psoriatic
- What is being tested?
- apremilast
- How many people
- 106 participants
- Where
- 22 sitesBelgium
- Study dates
- 21 Apr 2017to 27 Dec 2018
- Phase
- Observational
- 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
Study population: Adult patients with active PsA visiting rheumatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria. The decision to treat the patient with apremilast will be made prior to the decision to enter the patient into the study.
Who may be able to join
- Patients who meet ALL the following criteria can be enrolled:
- Male or female aged at least 18 years,
- With a diagnosis of active Psoriatic Arthritis (PsA),
- For whom the treating physician has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria (refer to the reimbursement conditions mentioned in Section 1.2),
- Able to follow the instructions of the study,
- Having signed an Informed Consent Form (ICF).
Who cannot join
- Patients who meet AT LEAST one of the following exclusion criteria will be excluded:
- Women who are pregnant, breastfeeding or planning on becoming pregnant,
- Non-menopausal women who are not using an adequate contraception method,
- Patients with hypersensitivity to apremilast or to one of its excipients.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Belgium22 sites
ASZ Aalst
Aalst, 9300
Onze Lieve Vrouw Aalst
Aalst, 9300
AZ Sint-Jan
Bruges, 8000
CHU St Pierre (César de Paepe)
Brussels, 1000
Clinicque Saint-Jean Botanique
Brussels, 1000
CHU Brugmann
Brussels, 1020
Clin Univ de Bxl Hôpital Erasme
Brussels, 1170
Cliniques Universiatires Saint-Luc
Brussels, 1200
Private Practice
Céroux-Mousty, 1341
UZ Antwerpen
Edegem, 2650
Reumacentrum Genk
Genk, 3600
Reumaclinic
Genk, 3600
UZ Gent
Ghent, 9000
GHdC Site Saint-Joseph
Gilly, 6060
CHU UCL Mont-Godinne
Godinne, 5530
Reuma Instituut
Hasselt, 3500
AZ Zeno campus Knokke-Heist
Knokke-Heist, 8300
UZ Leuven Gasthuisberg
Leuven, 3000
CHU Sart-Tilman
Liège, 4000
Reumatologie Medizorg
Merksem, 2170
ZNA Jan Palfijn
Merksem, 2170
Private Practice
Uccle, 1180
About this study
Official title: An Observational Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium
The study will include a representative sample of 150 patients with active Psoriatic Arthritis (PsA) for whom the treating rheumatologist has decided to begin treatment with apremilast. This study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating rheumatologist, in accordance with the local label and daily clinical practice. APOLO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study.
Read the detailed description
Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating rheumatologist every 3 months. In this study, patients will be followed-up for a least 6 months and at most 18 months after apremilast treatment initiation. Patient data will be collected until 31st December 2018. Assuming a recruitment phase of 18-month duration starting as of December 2016, individual patient follow-up times will range from 6 to 18 months, depending on the inclusion date. During the first months of the study, the recruitment rate has been slower than expected. Therefore, it has been decided in October 2017 to increase the period of recruitment to 18 months in order to have enough evaluable patients to keep the accuracy required for the statistical analysis.
During the study, it is expected to collect data at inclusion and at 6 months after apremilast initiation in all patients. As per NIHDI recommendations, patients should consult their treating rheumatologists 6 months after apremilast initiation in order to evaluate treatment response and decide on treatment continuation for an additional period of 12 months. For patients recruited early in the study, data will be collected during the next follow-up visits up to 18 months after apremilast initiation. Only data pertaining to visits occurring at 9 (± 1), 12 (± 1), 15 (±1), and 18 (± 1) months after treatment initiation will be collected. If a study visit occurs approximately 3 (± 1) months after treatment initiation, the data will also be recorded.
All clinical data collected during this non-interventional study will be routinely documented in the patient's medical records, which are the main source of information. The study data will be collecting via an electronic Case Report Form (eCRF). Data from source documents including PRO-questionnaires will be entered in the eCRF by the investigator or other authorised appropriately designed and trained study site personnel. Data entered into the eCRF will be reviewed for consistency by the Data Manager using both automated logical checks (issuing in automatic queries generated by the system) and manual review (issuing in manual checks set by the Data Manager or the Monitor into the eCRF). All data collected within the eCRF will be approved and electronically signed and dated by the Investigator or designee. At the conclusion of the study, before the final statistical analysis, the eCRF and other study data will be locked to further additions or corrections.
During the study, the Clinical Research Associate (CRA) will contact each study site on a regular basis in order to check the progress and conduct of the study. If issues regarding study conduct arise, additional on-site visits may be performed. In particular, a quality analysis will also be performed and based on data quality, it will be decided whether on-site monitoring is necessary, for which site and on which percentage of patients. During monitoring visits, eCRFs, patient's source documents, and all other study documentation will be reviewed by the CRA. Accuracy will be checked by performing source data verification that is a direct comparison of the entries made onto the eCRF against the appropriate source documentation.
Adverse events AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) terminology.
The detailed methodology of the statistical analyses will be documented in a statistical analysis plan (SAP). The SAP will be written by the Clinical Research Organisation (CRO) in charge of the study and will be validated by sponsor prior to performing the analysis and obligatory before the database lock. A scientific committee has been selected for this study. This committee will provide advice on the SAP.
- Conditions
- Arthritis, Psoriatic
- Being tested
- apremilast
- Keywords
- Psoriatic Arthritis, Observational, Otezla, Apremilast, Real-Life management, Belgium, APOLO, CC-10004
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
apremilastDrug
Psoriatic arthritis patients treated with Otezla® (apremilast) in Belgium
| Study group | Role | What they receive |
|---|---|---|
| Use of apremilast in patients with active PsA | Psoriatic arthritis patients treated with Otezla® (apremilast) in Belgium Receives: Drug: apremilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients showing response assessed by improvement for at least 2 out of 4 measures which compose the Psoriatic Arthritis Response Criteria (PsARC) at 6 months after apremilast initiation with respect to baseline
The PsARC tool is a composite response measure that has been specifically developed to assess response to treatment in Psoriatic Arthritis (PsA). PsARC is considered as an acceptable primary endpoint by the European Medicines Agency (EMA) The response for a given subject is defined by an improvement for at least 2 out of 4 measures which compose the PsARC (Patient Global Assessment [PtGA] of disease activity, Patient Global Assessment [PGA] of disease activity, 68-joint count for pain/tenderness and 66 joint count for swelling) and no worsening in any of the 4 measures.
Measured: 6 months after Apremilast initiation
Secondary outcomes (12)
Characteristics of the patients treated with apremilast
The patients treated with Apremilast will be described according to the following characteristics: demographics (age, gender, weight, height, and ethnicity), professional status, lifestyle habits, medical history (including psoriasis and PsA treatment
Measured: Baseline
Change from baseline in measures which compose the PsARC (PtGA of disease activity, PGA of disease activity, 68-joint count for pain/tenderness, and 66-joint count for swelling)
The PsARC tool is a composite response measure that has been specifically developed to assess response to treatment in PsA. PsARC is considered as an acceptable primary endpoint by the European Medicines Agency (EMA) The response for a given subject is defined by an improvement for at least 2 out of 4 measures which compose the PsARC (Patient Global Assessment [PtGA] of disease activity, Patient Global Assessment [PGA] of disease activity, 68-joint count for pain/tenderness and 66 joint count for swelling) and no worsening in any of the 4 measures.
Measured: up to 18 months
Change from Baseline in Psoriatic Arthritis Impact Of Disease 12 [PsAID12] score
The total score is divided by 20 and the final score ranges from 0 to 10, where '10' represents the worst health score. PsAID 12 is a questionnaire assessing 12 domains (pain, fatigue, skin, work and/or leisure activities, function, discomfort, sleep, coping, anxiety, embarrassment, social life, and depression) based on a 0-10 NRS, each parameter having a different coefficient.
Measured: up to 18 months
Change from Baseline in Health Assessment Questionnaire Disability Index [HAQ-DI] score
The Health Assessment Questionnaire (HAQ) is a validated PRO questionnaire designed to measure health status and health-related quality of life. It consists of 20 items covering activities of daily living classified in 8 domains. Respondents indicate for every item whether they can do the activity 'without any difficulty', with 'some' or 'much difficulty' or are 'unable to do' the activity. The HAQ yields a disability index (HAQ-DI) score between 0 and 3, where, 0 means no functional disability and 3 represents severe functional disability.
Measured: up to 18 months
Change from Baseline in disease activity Numerical Rating Scale (NRS)
Is an 11-point horizontal scale anchored at 0 and 10, with 0 representing "no disease activity" and 10 representing "maximal disease activity".
The patient's global self-assessment of disease activity is measured on a 0 to 10 unit NRS. The physician's global assessment of disease activity is also measured on a 0 to 10 unit NRS. For patient's assessment and for the physician's assessment, the NRS
Measured: up to 18 months
Change from Baseline in pain/itch Visual Analogue Scale [VAS]
The patient is asked to mark the line at the point that best represented the intensity of his or her pain and itch respectively. The VAS numeric values are the distances in millimeters from "no pain" and "no itch" respectively to the points marked by the patient. The pain VAS consists of a 100-mm horizontal line anchored at one end with the words "no pain" and at the other end with the words "worst possible pain".
Measured: up to 18 months
Change from Baseline in body surface area (BSA)
The investigator evaluates the percentage involvement of psoriasis on each participant's BSA on a continuous scale from 0% = no involvement to 100% = full involvement, where 1% corresponded to the size of the participant's handprint including the palm, fingers, and thumb
Measured: up to 18 months
Change from Baseline in Leeds Enthesitis Index (LEI)
The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site is assigned a score of 0 (absent) or 1 (present); the results from each site is then added to produce a total score (range 0 to 6).
Measured: up to 18 months
Change from Baseline in Dactylitis score
Each digit on the hands and feet is rated as zero for no dactylitis or 1 for dactylitis present. The dactylitis severity score is the sum of the individual scores for each digit. The dactylitis severity score, ranging from 0 to 20, is the number of digits on the hands and feet with dactylitis present. Dactylitis is characterized by swelling of the entire finger or toe.
Measured: up to 18 months
Mean duration of treatment with apremilast in biologic-naïve patients and in patients having received a previous biological treatment.
Time to the stop of the treatment by Apremilast will be calculated as the time interval from the date of apremilast initiation to the date of the apremilast stop
Measured: up to 18 months
Rate and reasons for discontinuation of apremilast treatment within 6 months after initiation
Descriptive statistics will be provided for the rate and reasons for discontinuation of treatment within 6 months. This analysis will be performed on safety population and restricted to patients who stop the treatment before the time point to analyse or for which the follow-up is at least so long as the time point to analyse.
Measured: Up to 6 months
Adverse Events (AEs)
Number of participants with adverse event
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start21 Apr 2017
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
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 Arthritis, PsoriaticStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096990
- Sponsor's protocol ID
- CC-10004-PSA-010
- Other IDs
- U1111-1194-0305
- Acronym
- APOLO
- Status last verified
- Apr 2020
- First submitted
- 24 Mar 2017
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
de Vlam K, Toukap AN, Kaiser MJ, Vanhoof J, Remans P, Van den Berghe M, Di Romana S, Van den Bosch F, Lories R. Real-World Efficacy and Safety of Apremilast in Belgian Patients with Psoriatic Arthritis: Results from the Prospective Observational APOLO Study. Adv Ther. 2022 Feb;39(2):1055-1067. doi: 10.1007/s12325-021-02016-x. Epub 2022 Jan 3.
PubMed 34977986
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of the Real-life Management of Psoriatic Arthritis Patients Treated With Otezla® (Apremilast) in Belgium
- ClinicalTrials.gov ID
- NCT03096990
- Acronym / sponsor ID
- APOLO / CC-10004-PSA-010
- Conditions
- Arthritis, Psoriatic
- Keywords
- Psoriatic Arthritis, Observational, Otezla, Apremilast, Real-Life management, Belgium, APOLO, CC-10004
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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.
The study will include a representative sample of 150 patients with active Psoriatic Arthritis (PsA) for whom the treating rheumatologist has decided to begin treatment with apremilast. This study is non-interventional, drug dosing and treatment duration will be at the sole discretion of the treating rheumatologist, in accordance with the local label and daily clinical practice. APOLO is a national (Belgium), multicentre, prospective, non-interventional, post-marketing study.
Detailed description
Patient care will follow routine clinical practice, involving regular follow-up visits, without any mandatory visit. In daily practice, patients are usually seen by their treating rheumatologist every 3 months. In this study, patients will be followed-up for a least 6 months and at most 18 months after apremilast treatment initiation. Patient data will be collected until 31st December 2018. Assuming a recruitment phase of 18-month duration starting as of December 2016, individual patient follow-up times will range from 6 to 18 months, depending on the inclusion date. During the first months of the study, the recruitment rate has been slower than expected. Therefore, it has been decided in October 2017 to increase the period of recruitment to 18 months in order to have enough evaluable patients to keep the accuracy required for the statistical analysis.
During the study, it is expected to collect data at inclusion and at 6 months after apremilast initiation in all patients. As per NIHDI recommendations, patients should consult their treating rheumatologists 6 months after apremilast initiation in order to evaluate treatment response and decide on treatment continuation for an additional period of 12 months. For patients recruited early in the study, data will be collected during the next follow-up visits up to 18 months after apremilast initiation. Only data pertaining to visits occurring at 9 (± 1), 12 (± 1), 15 (±1), and 18 (± 1) months after treatment initiation will be collected. If a study visit occurs approximately 3 (± 1) months after treatment initiation, the data will also be recorded.
All clinical data collected during this non-interventional study will be routinely documented in the patient's medical records, which are the main source of information. The study data will be collecting via an electronic Case Report Form (eCRF). Data from source documents including PRO-questionnaires will be entered in the eCRF by the investigator or other authorised appropriately designed and trained study site personnel. Data entered into the eCRF will be reviewed for consistency by the Data Manager using both automated logical checks (issuing in automatic queries generated by the system) and manual review (issuing in manual checks set by the Data Manager or the Monitor into the eCRF). All data collected within the eCRF will be approved and electronically signed and dated by the Investigator or designee. At the conclusion of the study, before the final statistical analysis, the eCRF and other study data will be locked to further additions or corrections.
During the study, the Clinical Research Associate (CRA) will contact each study site on a regular basis in order to check the progress and conduct of the study. If issues regarding study conduct arise, additional on-site visits may be performed. In particular, a quality analysis will also be performed and based on data quality, it will be decided whether on-site monitoring is necessary, for which site and on which percentage of patients. During monitoring visits, eCRFs, patient's source documents, and all other study documentation will be reviewed by the CRA. Accuracy will be checked by performing source data verification that is a direct comparison of the entries made onto the eCRF against the appropriate source documentation.
Adverse events AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) terminology.
The detailed methodology of the statistical analyses will be documented in a statistical analysis plan (SAP). The SAP will be written by the Clinical Research Organisation (CRO) in charge of the study and will be validated by sponsor prior to performing the analysis and obligatory before the database lock. A scientific committee has been selected for this study. This committee will provide advice on the SAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of apremilast in patients with active PsA | – | Drug: apremilastPsoriatic arthritis patients treated with Otezla® (apremilast) in Belgium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with active PsA visiting rheumatology practices in Belgium and eligible for treatment with apremilast according to the local label and reimbursement criteria. The decision to treat the patient with apremilast will be made prior to the decision to enter the patient into the study.
Key inclusion criteria (6 listed)
- Patients who meet ALL the following criteria can be enrolled:
- Male or female aged at least 18 years,
- With a diagnosis of active Psoriatic Arthritis (PsA),
- For whom the treating physician has made the decision to commence apremilast treatment in accordance with the local label and reimbursement criteria (refer to the reimbursement conditions mentioned in Section 1.2),
- Able to follow the instructions of the study,
Key exclusion criteria (4 listed)
- Patients who meet AT LEAST one of the following exclusion criteria will be excluded:
- Women who are pregnant, breastfeeding or planning on becoming pregnant,
- Non-menopausal women who are not using an adequate contraception method,
- Patients with hypersensitivity to apremilast or to one of its excipients.
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 |
|---|---|---|
| apremilastPsoriatic arthritis patients treated with Otezla® (apremilast) in Belgium | Drug | Use of apremilast in patients with active PsA |
Primary outcome
Proportion of patients showing response assessed by improvement for at least 2 out of 4 measures which compose the Psoriatic Arthritis Response Criteria (PsARC) at 6 months after apremilast initiation with respect to baseline
Time frame: 6 months after Apremilast initiation
The PsARC tool is a composite response measure that has been specifically developed to assess response to treatment in Psoriatic Arthritis (PsA). PsARC is considered as an acceptable primary endpoint by the European Medicines Agency (EMA) The response for a given subject is defined by an improvement for at least 2 out of 4 measures which compose the PsARC (Patient Global Assessment [PtGA] of disease activity, Patient Global Assessment [PGA] of disease activity, 68-joint count for pain/tenderness and 66 joint count for swelling) and no worsening in any of the 4 measures.
12 secondary outcomes
Characteristics of the patients treated with apremilast
Time frame: Baseline
Change from baseline in measures which compose the PsARC (PtGA of disease activity, PGA of disease activity, 68-joint count for pain/tenderness, and 66-joint count for swelling)
Time frame: up to 18 months
Change from Baseline in Psoriatic Arthritis Impact Of Disease 12 [PsAID12] score
Time frame: up to 18 months
Change from Baseline in Health Assessment Questionnaire Disability Index [HAQ-DI] score
Time frame: up to 18 months
Change from Baseline in disease activity Numerical Rating Scale (NRS)
Time frame: up to 18 months
Change from Baseline in pain/itch Visual Analogue Scale [VAS]
Time frame: up to 18 months
Change from Baseline in body surface area (BSA)
Time frame: up to 18 months
Change from Baseline in Leeds Enthesitis Index (LEI)
Time frame: up to 18 months
Change from Baseline in Dactylitis score
Time frame: up to 18 months
Mean duration of treatment with apremilast in biologic-naïve patients and in patients having received a previous biological treatment.
Time frame: up to 18 months
Rate and reasons for discontinuation of apremilast treatment within 6 months after initiation
Time frame: Up to 6 months
Adverse Events (AEs)
Time frame: up to 18 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 29 Apr 2020.
- Derived from this study: PubMed 34977986de Vlam K, Toukap AN, Kaiser MJ, Vanhoof J, Remans P, Van den Berghe M, Di Romana S, Van den Bosch F, Lories R. Real-World Efficacy and Safety of Apremilast in Belgian Patients with Psoriatic Arthritis: Results from the Prospective Observational APOLO Study. Adv Ther. 2022 Feb;39(2):1055-1067. doi: 10.1007/s12325-021-02016-x. Epub 2022 Jan 3.
- Expanded Access for CC-10004Link provided by the sponsor.
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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.
MD study director
Amgen
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Psoriatic, run by Amgen at 22 sites in Belgium.
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 6 inclusion and 4 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 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Belgium. 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.
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?
Proportion of patients showing response assessed by improvement for at least 2 out of 4 measures which compose the Psoriatic Arthritis Response Criteria (PsARC) at 6 months after apremilast initiation with respect to baseline (time frame: 6 months after Apremilast initiation). 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 NCT03096990, 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 29 Apr 2020.