OsteoarthritisPhase 2NCT02845271
Proof-of-concept Study to Assess the Efficacy, Tolerability and Safety of a Single Intraarticular Dose of GZ389988 Versus Placebo in Patients With Painful Osteoarthritis of the Knee
A Phase 2 study testing GZ389988, acetaminophen or paracetamol and fixed combination of paracetamol + codeine in people with Osteoarthritis, run by Genzyme, a Sanofi Company at 2 sites in Germany.
Trial summary
Primary Objective: To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for relief of knee pain in patients with osteoarthritis (OA) of the knee. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- GZ389988, acetaminophen or paracetamol and fixed combination of paracetamol + codeine
- 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
- 104 participants
- Where
- 2 sitesGermany
- Study dates
- 21 Jul 2016to 13 Sep 2017
- Phase
- Phase 2
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women 40 to 80 years of age.
- Diagnosis of primary knee osteoarthritis (OA), based upon the following:
- Fulfilling the American College of Rheumatology Clinical and Radiographic criteria for OA (at least knee pain and osteophytes), with
- X-ray evidence within the last 6 months for Kellgren and Lawrence classification II to IV.
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Pain subscore (walking pain) over the last 48 hours ≥40 and ≤90 on VAS 0-100 in the target knee at screening with or without medication, and ≤30 on Visual Analogue Scale (VAS) 0-100 in the contralateral knee at screening with or without medication.
- WOMAC A1 pain subscore (walking pain) between 50 and 90 using the VAS 0-100, corresponding to moderate to severe pain in the target knee at baseline (from eDiary, average of at least 3 days in the time window between Day-5 and Day-1).
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- Symptomatic for more than 6 months (if both symptomatic knees, at least for the most painful knee that will receive the study drug).
- Having given written informed consent prior to any procedure related to the study.
- Ambulatory with an active lifestyle and in good general health. (Assistive devices were allowed if used throughout a period of 3 months or more prior to screening, on the condition that they continue to be used throughout the study).
- A male who is sexually active must use a condom as part of a method of highly effective contraception (eg, condom + spermicide, and an additional contraceptive method used by the partner) during sexual intercourse with a women of childbearing potential for the duration of the study period up to the end-of-study visit and should not father a child in this period. Male patients also have to agree not to donate sperm for the duration of the study until the end-of-study visit.
Who cannot join
- Women of childbearing potential.
- Pregnant or breastfeeding women.
- Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Investigator, could potentially put the patient at increased risk.
- Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (including diabetic neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition, such as symptomatic peripheral vascular disease of the study leg (prior or current), clinically significant venous or lymphatic stasis present in the study leg, that might interfere with the evaluation of investigational medicinal product (IMP) according to Investigator's medical judgment.
- Chondrocalcinosis.
- Fibromyalgia.
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- Moderately severe or severe depression as indicated by Patient Health Questionnaire-9 (PHQ-9) total score at screening visit.
- Severe anxiety as indicated by Generalized Anxiety Disorder (GAD-7) score at screening visit.
- History or presence of drug or alcohol abuse (alcohol consumption >40 grams per day).
- Any patient who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development, or unable to use an electronic diary daily.
- Abnormal coagulation parameters: outside the range international normalized ratio (INR) 0.85-1.15, activated partial thromboplastin time >33 seconds, platelets <140 x 10^9/L.
- Moderate to severe renal impairment.
- Underlying hepatobiliary disease and/or alanine aminotransferase (ALT) >2 x upper limit of normal (ULN).
- High sensitivity C-reactive protein (hsCRP) >2 x ULN.
- Hemoglobin <10 g/dL, white blood cell count (WBC) <3 x 10^9/L.
- Positive result on any of the following tests: hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
- Secondary OA. -Ipsilateral hip OA.-
- History of osteonecrosis and/or rapidly progressive OA (RPOA).
- Intraarticular injection within 3 months prior to inclusion.
- Unable to be maintained for at least 2 weeks prior to entry into study on paracetamol (no non-steroidal anti-inflammatory drug [NSAID] use during the 12 weeks of the study; after the end-of-study visit [Day 84 ± 7] patients may be given an NSAID if necessary to provide better control of OA symptoms).
- Any IMP within 3 months prior to the study.
- Any knee magnetic resonance imaging (MRI) contraindication.
- Patients at risk of developing a RPOA with pre-existing findings on MRI of the target knee at baseline.
- Patients with pain DETECT questionnaire (PD-Q) score >18.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Investigational Site Number 276001
Berlin, 14050
Investigational Site Number 276002
Lübeck, 23538
About this study
Official title: A Two Part Protocol Using Double Blind Placebo Control to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Intra-articular Doses Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Intra-articular Dose of the TrkA Inhibitor, GZ389988, in Patients With Painful Osteoarthritis of the Knee
Primary Objective:
To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for relief of knee pain in patients with osteoarthritis (OA) of the knee.
Secondary Objectives:
To assess the safety and tolerability of a single intraarticular dose of GZ389988 in patients with painful OA of the knee.
To assess the pharmacokinetic parameters of a single intraarticular dose of GZ389988 in patients with painful OA of the knee.
Read the detailed description
Screening will be performed within 21 days of dosing. Following the single dose of study medication, the study period for each patient will be 84 ± 7 days up to the end-of-study visit.
Total duration for one patient will be up to 16 weeks (up to the end-of-study visit), not including the long-term observational safety follow-up phone call for 12 additional weeks.
The collection of primary endpoint data up to Week 4 for futility analysis is optional. Assuming a possible step-down in dose due to safety/tolerability reasons, the total expected maximum number of included patients could be increased up to a maximum of 182 patients.
- Conditions
- Osteoarthritis
- Being tested
- placebo, GZ389988, acetaminophen or paracetamol, fixed combination of paracetamol + codeine, fixed combination of paracetamol + tramadol hydrochloride
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Pharmaceutical form:solvent for parenteral use
Route of administration: intraarticular
GZ389988Drug
Pharmaceutical form:suspension for injection
Route of administration: intraarticular
acetaminophen or paracetamolDrug
Pharmaceutical form: tablet
Route of administration: oral
fixed combination of paracetamol + codeineDrug
Pharmaceutical form: capsule
Route of administration: oral
fixed combination of paracetamol + tramadol hydrochlorideDrug
Pharmaceutical form: tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| GZ389988 | Experimental | Single intraarticular injection of GZ389988 in the knee joint Receives: Drug: GZ389988; Drug: acetaminophen or paracetamol; Drug: fixed combination of paracetamol + codeine; Drug: fixed combination of paracetamol + tramadol hydrochloride |
| Placebo | Placebo comparator | Single intraarticular injection of placebo for GZ389988 in the knee joint Receives: Drug: placebo; Drug: acetaminophen or paracetamol; Drug: fixed combination of paracetamol + codeine; Drug: fixed combination of paracetamol + tramadol hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weekly mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 pain subscore (walking pain) collected daily in the target knee, as measured by the Visual Analogue Scale (VAS) 0-100
Measured: Averaged over 4 weeks (up to Day 28)
Secondary outcomes (13)
Change from baseline in weekly mean score of WOMAC A1 pain sub-score (walking pain) collected daily in the target knee, as measured by the VAS 0-100
Measured: Averaged over 12 weeks (up to Day 84)
Change from baseline in weekly mean score of WOMAC A1 pain sub-score collected daily in the target knee
Measured: Averaged over 1, 2, 3, 6, 8, and 10 weeks
Change from baseline in weekly mean score of WOMAC A1 pain sub-score collected daily in the target knee
Measured: At 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Change from baseline in weekly mean score of overall knee pain collected daily in the target knee
Measured: At and averaged over 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Change from baseline in Patient Global Assessment (PGA) of disease status
Measured: At and averaged over 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Change from baseline in WOMAC index (total score for pain, stiffness, and physical function subscales), pain, stiffness and physical function sub-scores
Measured: Averaged over 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Patient Global Impression of Change (PGIC)
Measured: Over the last 4 weeks at Day 28 (1 to 4 weeks), Day 56 (5 to 8 weeks), and Day 84 (9 to 12 weeks)
Patient Global Assessment of Response to Therapy (PGART)
Measured: Over the last 4 weeks at Day 28 (1 to 4 weeks), Day 56 (5 to 8 weeks), and Day 84 (9 to 12 weeks)
Rate of response to therapy according to Outcome Measures in Rheumatology committee (OMERACT) and the Osteoarthritis Research Society International (OARSI)
OMERACT and OARSI responder criteria are based on the symptomatic variables pain and function, or pain, function and patient's global assessment
Measured: By Day 28, Day 56, and Day 84
WOMAC A1 responder rate based on percentage of patients with reduction in pain intensity of at least 30% and 50% at endpoint compared to baseline
Measured: Over 4 weeks (up to Day 28) and 12 weeks (up to Day 84) and at 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Time to first WOMAC A1 response for ≥30% reduction in pain intensity
Measured: At 1, 2, 3, 4, 6, 8, 10, 12 weeks
Time to first WOMAC A1 response for 50% reduction in pain intensity
Measured: At 1, 2, 3, 4, 6, 8, 10, 12 weeks
Amount of rescue medication intake
Measured: Up to Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start21 Jul 2016
- Primary completion28 Jun 2017
- Study completion13 Sep 2017
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 OsteoarthritisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845271
- Sponsor's protocol ID
- ACT13830
- Other IDs
- 2014-004805-34, U1111-1163-0806, 2014
- Status last verified
- Apr 2022
- First submitted
- 19 Jul 2016
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Krupka E, Jiang GL, Jan C. Efficacy and safety of intra-articular injection of tropomyosin receptor kinase A inhibitor in painful knee osteoarthritis: a randomized, double-blind and placebo-controlled study. Osteoarthritis Cartilage. 2019 Nov;27(11):1599-1607. doi: 10.1016/j.joca.2019.05.028. Epub 2019 Jul 25.
PubMed 31351965
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part Protocol Using Double Blind Placebo Control to Assess the Safety, Tolerability, and Pharmacokinetics of Single Escalating Intra-articular Doses Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Intra-articular Dose of the TrkA Inhibitor, GZ389988, in Patients With Painful Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02845271
- Acronym / sponsor ID
- ACT13830
- Conditions
- Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 27 Jul 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.
Primary Objective:
To assess the efficacy of a single intraarticular dose of GZ389988 compared to placebo for relief of knee pain in patients with osteoarthritis (OA) of the knee.
Secondary Objectives:
To assess the safety and tolerability of a single intraarticular dose of GZ389988 in patients with painful OA of the knee.
To assess the pharmacokinetic parameters of a single intraarticular dose of GZ389988 in patients with painful OA of the knee.
Detailed description
Screening will be performed within 21 days of dosing. Following the single dose of study medication, the study period for each patient will be 84 ± 7 days up to the end-of-study visit.
Total duration for one patient will be up to 16 weeks (up to the end-of-study visit), not including the long-term observational safety follow-up phone call for 12 additional weeks.
The collection of primary endpoint data up to Week 4 for futility analysis is optional. Assuming a possible step-down in dose due to safety/tolerability reasons, the total expected maximum number of included patients could be increased up to a maximum of 182 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GZ389988 | Experimental | Drug: GZ389988, Drug: acetaminophen or paracetamol, Drug: fixed combination of paracetamol + codeine, Drug: fixed combination of paracetamol + tramadol hydrochlorideSingle intraarticular injection of GZ389988 in the knee joint |
| Placebo | Placebo comparator | Drug: placebo, Drug: acetaminophen or paracetamol, Drug: fixed combination of paracetamol + codeine, Drug: fixed combination of paracetamol + tramadol hydrochlorideSingle intraarticular injection of placebo for GZ389988 in the knee joint |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men or women 40 to 80 years of age.
- Diagnosis of primary knee osteoarthritis (OA), based upon the following:
- Fulfilling the American College of Rheumatology Clinical and Radiographic criteria for OA (at least knee pain and osteophytes), with
- X-ray evidence within the last 6 months for Kellgren and Lawrence classification II to IV.
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 Pain subscore (walking pain) over the last 48 hours ≥40 and ≤90 on VAS 0-100 in the target knee at screening with or without medication, and ≤30 on Visual Analogue Scale (VAS) 0-100 in the contralateral knee at screening with or without medication.
Key exclusion criteria (25 listed)
- Women of childbearing potential.
- Pregnant or breastfeeding women.
- Any uncontrolled, chronic condition or laboratory finding which, in the opinion of the Investigator, could potentially put the patient at increased risk.
- Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (including diabetic neuropathy), psychiatric, hematological, renal, or dermatological disease, or any other medical condition, such as symptomatic peripheral vascular disease of the study leg (prior or current), clinically significant venous or lymphatic stasis present in the study leg, that might interfere with the evaluation of investigational medicinal product (IMP) according to Investigator's medical judgment.
- Chondrocalcinosis.
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 |
|---|---|---|
| placeboPharmaceutical form:solvent for parenteral use Route of administration: intraarticular | Drug | Placebo |
| GZ389988Pharmaceutical form:suspension for injection Route of administration: intraarticular | Drug | GZ389988 |
| acetaminophen or paracetamolPharmaceutical form: tablet Route of administration: oral | Drug | GZ389988, Placebo |
| fixed combination of paracetamol + codeinePharmaceutical form: capsule Route of administration: oral | Drug | GZ389988, Placebo |
| fixed combination of paracetamol + tramadol hydrochloridePharmaceutical form: tablet Route of administration: oral | Drug | GZ389988, Placebo |
Primary outcome
Change from baseline in weekly mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 pain subscore (walking pain) collected daily in the target knee, as measured by the Visual Analogue Scale (VAS) 0-100
Time frame: Averaged over 4 weeks (up to Day 28)
13 secondary outcomes
Change from baseline in weekly mean score of WOMAC A1 pain sub-score (walking pain) collected daily in the target knee, as measured by the VAS 0-100
Time frame: Averaged over 12 weeks (up to Day 84)
Change from baseline in weekly mean score of WOMAC A1 pain sub-score collected daily in the target knee
Time frame: Averaged over 1, 2, 3, 6, 8, and 10 weeks
Change from baseline in weekly mean score of WOMAC A1 pain sub-score collected daily in the target knee
Time frame: At 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Change from baseline in weekly mean score of overall knee pain collected daily in the target knee
Time frame: At and averaged over 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Change from baseline in Patient Global Assessment (PGA) of disease status
Time frame: At and averaged over 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Change from baseline in WOMAC index (total score for pain, stiffness, and physical function subscales), pain, stiffness and physical function sub-scores
Time frame: Averaged over 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Patient Global Impression of Change (PGIC)
Time frame: Over the last 4 weeks at Day 28 (1 to 4 weeks), Day 56 (5 to 8 weeks), and Day 84 (9 to 12 weeks)
Patient Global Assessment of Response to Therapy (PGART)
Time frame: Over the last 4 weeks at Day 28 (1 to 4 weeks), Day 56 (5 to 8 weeks), and Day 84 (9 to 12 weeks)
Rate of response to therapy according to Outcome Measures in Rheumatology committee (OMERACT) and the Osteoarthritis Research Society International (OARSI)
Time frame: By Day 28, Day 56, and Day 84
WOMAC A1 responder rate based on percentage of patients with reduction in pain intensity of at least 30% and 50% at endpoint compared to baseline
Time frame: Over 4 weeks (up to Day 28) and 12 weeks (up to Day 84) and at 1, 2, 3, 4, 6, 8, 10, and 12 weeks
Time to first WOMAC A1 response for ≥30% reduction in pain intensity
Time frame: At 1, 2, 3, 4, 6, 8, 10, 12 weeks
Time to first WOMAC A1 response for 50% reduction in pain intensity
Time frame: At 1, 2, 3, 4, 6, 8, 10, 12 weeks
Amount of rescue medication intake
Time frame: Up to Day 84
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 13 Apr 2022.
- Derived from this study: PubMed 31351965Krupka E, Jiang GL, Jan C. Efficacy and safety of intra-articular injection of tropomyosin receptor kinase A inhibitor in painful knee osteoarthritis: a randomized, double-blind and placebo-controlled study. Osteoarthritis Cartilage. 2019 Nov;27(11):1599-1607. doi: 10.1016/j.joca.2019.05.028. Epub 2019 Jul 25.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Clinical Sciences & Operations study director
Sanofi
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GZ389988, acetaminophen or paracetamol and fixed combination of paracetamol + codeine in people with Osteoarthritis, run by Genzyme, a Sanofi Company at 2 sites in Germany.
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 10 inclusion and 25 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 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in weekly mean score of Western Ontario and McMaster Universities Arthritis Index (WOMAC) A1 pain subscore (walking pain) collected daily in the target knee, as measured by the Visual Analogue Scale (VAS) 0-100 (time frame: Averaged over 4 weeks (up to Day 28)). 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 NCT02845271, 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 13 Apr 2022.