Pemphigus VulgarisPhase 3NCT01920477
Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris
A Phase 3 study testing Ofatumumab in people with Pemphigus Vulgaris, run by Novartis Pharmaceuticals at 16 sites in 8 countries.
Trial summary
Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is expressed only in B lymphocytes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pemphigus Vulgaris
- What is being tested?
- Ofatumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 16 sitesin 8 countries
- Study dates
- 13 Aug 2013to 11 Jan 2018
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 through 70 years of age) with clinically-documented diagnosis of PV for >2 months and <10 years.
- History of biopsy consistent with PV (Hematoxylin and Eosin staining and direct immunofluorescence). If no history, a biopsy may be performed during the Screening Period.
- At least 1 previous episode of a failed steroid taper (ie, disease flare/relapse) at a prednisone/prednisolone dose >10 mg/day. The following criteria must have been met as evidence of disease severity at the time of the failed steroid taper: a) A Pemphigus Severity of Clinical Disease score of moderate (2) or severe (3) (may be historical/retrospective assessment). b) Required a treatment change at the time of the failed steroid taper of at least one of the following: i) A steroid increase to >=20 mg/day OR ii) The addition of immunosuppressive/immunomodulatory agent/treatment OR iii) A dose increase of immunosuppressive/immunomodulatory agent/treatment
- Screening anti-Dsg antibodies consistent with a diagnosis of PV (ie, elevated antiDsg3 antibodies).
- Has initiated and received a stable dose of prednisone/prednisolone from a minimum of 20 mg/day (example: 0.25 mg/kg/day for an 80 kg person) up to a maximum of 120 mg/day or 1.5 mg/kg/day (whichever is higher) for >=2 weeks prior to randomization.
- Has exhibited PV disease control, defined as no new lesions for >=2 weeks.
- A female subject is eligible to enter the study if she: Is of non-child bearing potential, who is either surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or post-hysterectomy) or is postmenopausal without menses for >2 years. Women who are <2 years postmenopausal are required to have menopausal status confirmed by follicle-stimulating hormone (FSH) and estradiol levels at the screening evaluation. If FSH and estradiol levels do not provide confirmation of menopause, subject will be considered to be of childbearing potential.
Who cannot join
- Diagnosis of pemphigus foliaceus, paraneoplastic pemphigus, or other autoimmune blistering disease (other than pemphigus vulgaris).
- Past or current history of hypersensitivity to components of the investigational product or medically significant adverse effects (including allergic reactions) from cetirizine (or antihistamine equivalent) or paracetamol/acetaminophen.
- Prior treatment with rituximab without achieving disease control within 6 months of initiating rituximab dosing.
- Prior treatment with immunosuppressant or immunomodulation agents within the protocol specified periods
- Evidence or history of clinically significant infections
- For Japan: Evidence or history of clinically significant infection or medical condition including: Pneumocystis pneumonia or interstitial pneumonia
Show all 11Show fewer
- Past or current malignancy, except for cervical carcinoma Stage 1B or less, noninvasive basal cell and squamous cell skin carcinoma and cancer diagnoses with a duration of complete response (remission) >5 years
- Significant concurrent, uncontrolled medical condition that could affect the subject's safety, impair the subject's reliable participation in the study, impair the evaluation of endpoints, or necessitate the use of medication not allowed by the protocol. This includes subjects who require any systemic steroid treatment for a concurrent medical condition (other than pemphigus vulgaris).
- Use of an investigational drug or other experimental therapy within 4 weeks, 5 pharmacokinetic half-lives, or the duration of biological effect (whichever is longer) prior to Screening.
- Electrocardiogram (ECG) showing a clinically significant abnormality or showing a QTc interval ≥450 msec (≥480 msec for subjects with a bundle branch block)
- Woman who is breastfeeding.
Trial locations and contacts
16 sites in 8 countries.
16 sites in 8 countries
United States7 sites
Novartis Investigational Site
Ann Arbor, Michigan, 48103
Novartis Investigational Site
Atlanta, Georgia, 30322
Novartis Investigational Site
Buffalo, New York, 14203
Novartis Investigational Site
Durham, North Carolina, 27710
Novartis Investigational Site
Los Angeles, California, 90045
Novartis Investigational Site
Pittsburgh, Pennsylvania, 15213
Novartis Investigational Site
Salt Lake City, Utah, 84132
Australia2 sites
Novartis Investigational Site
East Melbourne, Victoria, 3002
Novartis Investigational Site
Melbourne, Victoria, 3050
Israel2 sites
Novartis Investigational Site
Ramat Gan, 52621
Novartis Investigational Site
Tel Aviv, 64239
About this study
Official title: OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris
Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is expressed only in B lymphocytes.
The purpose of this study was to evaluate the efficacy, tolerability, and safety of ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every 4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both Week 0 and Week 4) in subjects with PV. It was anticipated that with sustained B-cell depletion in the presence of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein) autoantibodies in PV, that clinical remission of the disease would result.
Read the detailed description
Novartis terminated the development of the PV program and this study was terminated for non-safety reasons
- Conditions
- Pemphigus Vulgaris
- Being tested
- Ofatumumab, Placebo
- Keywords
- Pemphigus, MAB, autoimmune disorder, human CD20 antigen, subcutaneous, vulgaris, Phase 3, monoclonal antibody, ofatumumab, PV, rare disease, OMB157, adult
- Medical subject headings
- Pemphigus, Autoimmune Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OfatumumabBiological
Ofatumumab (human monoclonal antibody) was provided in prefilled glass syringes initial syringes contained 0.6ml (60mg) of concentration 100 mg/m: drug product subsequently modified to 0.4 mL (20mg) concentration (50mg/ML) drug product
PlaceboBiological
Placebo to match the active doses will consist of prefilled glass syringes filled with normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Ofatumumab | Experimental | Subject received subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4. Receives: Biological: Ofatumumab |
| Placebo | Placebo comparator | Subject received subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy
Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintenance of a dose <=10 mg/day with no new or nonhealing lesions for >=8 weeks and maintenance of the status until Week 60.
Measured: Baseline up to approximately 60 weeks
Duration of Remission on Minimal Steroid Therapy
Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day up to Week 60 was assessed.
Measured: Baseline up to approximately 60 weeks
Secondary outcomes (12)
Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60
Percentage of subjects who achieved absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day for > or = 8 weeks at Week 60 was assessed. Time to remission was not estimable.
Measured: Week 60
Time to Remission While on Minimal Steroid Therapy by Week 60.
Time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintained dose at <=10 mg/day with no new or nonhealing lesions for >=8 weeks by Week 60 was assessed
Measured: Baseline up to approximately 60 weeks
Percentage of Subjects Achieving Remission While Off Steroid Therapy by Week 60
Percentage of subjects with initial reduction of all steroids for >=8 weeks with an absence of new or nonhealing (established) lesions by Week 60 were to be assessed. All subjects remained on prednisone/prednisolone so this endpoint could not be analyzed.Time to remission off steroid therapy also could not be analyzed
Measured: Baseline up to approximately 60 weeks
Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.
Number of days a subject maintained minimal steroid therapy (an oral prednisone/prednisolone dose of ≤10 mg/day in the absence of new or nonhealing lesions) by Week 60.
Measured: Baseline up to approximately 60 weeks
Time to Initial Flare/Relapse by Week 60
Time from randomization to the time of appearance of >=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
Measured: Baseline up to approximately 60 weeks
Percentage of Participants With no Flare/Relapse by Week 60
Percentage of participants achieving absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day and did not subsequently have a appearance of >=3 new lesions within 1 month that did not heal spontaneously within 1 week, or to the time when there was an extension of lesions that were present at the randomization by Week 60 was assessed
Measured: Baseline up to approximately 60 weeks
Plasma Trough Concentrations of Ofatumumab
Only plasma (trough) concentrations of ofatumumab were presented
Measured: 4 hours post baseline, Days 1-4,7,14, Weeks 4,8,12,16,20,24,36,48,52,56, up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Measured: Baseline up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Measured: Baseline up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Measured: Baseline up to approximately 60 weeks
Largest Mean Decrease From Baseline for Immunoglobulin A, G and M
Immunoglobulins A, G and M were assessed by the incidence, titer, and type of human anti-human antibody (HAHA) immune response
Measured: Baseline up to approximately 60 weeks
Change From Baseline for CD19+ B Cell Count
CD19+ B cell count will be performed using Flow Cytometry
Measured: Baseline up to approximately 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study start13 Aug 2013
- Primary completion13 Apr 2016
- Study completion11 Jan 2018
Why it stopped: Novartis has acquired the rights to ofatumumab and terminated the OPV116910 and OPV117059 studies. This decision is not linked to any safety consideration.
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.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920477
- Sponsor's protocol ID
- 116910
- Status last verified
- May 2019
- First submitted
- 3 Jul 2013
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPV116910: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Ofatumumab Injection for Subcutaneous Use in Subjects With Pemphigus Vulgaris
- ClinicalTrials.gov ID
- NCT01920477
- Acronym / sponsor ID
- 116910
- Conditions
- Pemphigus Vulgaris
- Keywords
- Pemphigus, MAB, autoimmune disorder, human CD20 antigen, subcutaneous, vulgaris, Phase 3, monoclonal antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Novartis has acquired the rights to ofatumumab and terminated the OPV116910 and OPV117059 studies. This decision is not linked to any safety consideration.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2013 (actual)
- Primary completion
- 13 Apr 2016 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is expressed only in B lymphocytes.
The purpose of this study was to evaluate the efficacy, tolerability, and safety of ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every 4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both Week 0 and Week 4) in subjects with PV. It was anticipated that with sustained B-cell depletion in the presence of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein) autoantibodies in PV, that clinical remission of the disease would result.
Detailed description
Novartis terminated the development of the PV program and this study was terminated for non-safety reasons
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ofatumumab | Experimental | Biological: OfatumumabSubject received subcutaneous administration of ofatumumab 20 mg once every 4 weeks through Week 56, with an additional 20 mg dose (that is 40mg total) at both Week 0 and Week 4. |
| Placebo | Placebo comparator | Biological: PlaceboSubject received subcutaneous administration of matching placebo of ofatumumab once every 4 weeks through Week 56, with an additional dose at both Week 0 and Week 4. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults (18 through 70 years of age) with clinically-documented diagnosis of PV for >2 months and <10 years.
- History of biopsy consistent with PV (Hematoxylin and Eosin staining and direct immunofluorescence). If no history, a biopsy may be performed during the Screening Period.
- At least 1 previous episode of a failed steroid taper (ie, disease flare/relapse) at a prednisone/prednisolone dose >10 mg/day. The following criteria must have been met as evidence of disease severity at the time of the failed steroid taper: a) A Pemphigus Severity of Clinical Disease score of moderate (2) or severe (3) (may be historical/retrospective assessment). b) Required a treatment change at the time of the failed steroid taper of at least one of the following: i) A steroid increase to >=20 mg/day OR ii) The addition of immunosuppressive/immunomodulatory agent/treatment OR iii) A dose increase of immunosuppressive/immunomodulatory agent/treatment
- Screening anti-Dsg antibodies consistent with a diagnosis of PV (ie, elevated antiDsg3 antibodies).
- Has initiated and received a stable dose of prednisone/prednisolone from a minimum of 20 mg/day (example: 0.25 mg/kg/day for an 80 kg person) up to a maximum of 120 mg/day or 1.5 mg/kg/day (whichever is higher) for >=2 weeks prior to randomization.
Key exclusion criteria (11 listed)
- Diagnosis of pemphigus foliaceus, paraneoplastic pemphigus, or other autoimmune blistering disease (other than pemphigus vulgaris).
- Past or current history of hypersensitivity to components of the investigational product or medically significant adverse effects (including allergic reactions) from cetirizine (or antihistamine equivalent) or paracetamol/acetaminophen.
- Prior treatment with rituximab without achieving disease control within 6 months of initiating rituximab dosing.
- Prior treatment with immunosuppressant or immunomodulation agents within the protocol specified periods
- Evidence or history of clinically significant infections
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 |
|---|---|---|
| OfatumumabOfatumumab (human monoclonal antibody) was provided in prefilled glass syringes initial syringes contained 0.6ml (60mg) of concentration 100 mg/m: drug product subsequently modified to 0.4 mL (20mg) concentration (50mg/ML) drug product | Biological | Ofatumumab |
| PlaceboPlacebo to match the active doses will consist of prefilled glass syringes filled with normal saline. | Biological | Placebo |
Primary outcome
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy
Time frame: Baseline up to approximately 60 weeks
Sustained remission = time from randomization to the time of the subject's initial reduction of prednisone/prednisolone dose to <=10 mg/day and maintenance of a dose <=10 mg/day with no new or nonhealing lesions for >=8 weeks and maintenance of the status until Week 60.
Duration of Remission on Minimal Steroid Therapy
Time frame: Baseline up to approximately 60 weeks
Sum of all periods of absence of new or nonhealing lesions while on an oral prednisone/prednisolone dose of <=10 mg/day up to Week 60 was assessed.
12 secondary outcomes
Percentage of Subjects Achieving Remission on Minimal Steroid Therapy at Week 60
Time frame: Week 60
Time to Remission While on Minimal Steroid Therapy by Week 60.
Time frame: Baseline up to approximately 60 weeks
Percentage of Subjects Achieving Remission While Off Steroid Therapy by Week 60
Time frame: Baseline up to approximately 60 weeks
Number of Days a Subject Maintained Minimal Steroid Therapy by Week 60.
Time frame: Baseline up to approximately 60 weeks
Time to Initial Flare/Relapse by Week 60
Time frame: Baseline up to approximately 60 weeks
Percentage of Participants With no Flare/Relapse by Week 60
Time frame: Baseline up to approximately 60 weeks
Plasma Trough Concentrations of Ofatumumab
Time frame: 4 hours post baseline, Days 1-4,7,14, Weeks 4,8,12,16,20,24,36,48,52,56, up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin A
Time frame: Baseline up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin G
Time frame: Baseline up to approximately 60 weeks
Number of Participants With Values Below Lower Limit of Normal for Immunoglobulin M
Time frame: Baseline up to approximately 60 weeks
Largest Mean Decrease From Baseline for Immunoglobulin A, G and M
Time frame: Baseline up to approximately 60 weeks
Change From Baseline for CD19+ B Cell Count
Time frame: Baseline up to approximately 60 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
16 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ofatumumab in people with Pemphigus Vulgaris, run by Novartis Pharmaceuticals at 16 sites in 8 countries.
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 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 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 16 sites in United States, Australia, Israel, Greece, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 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?
Number of Subjects Who Experienced Sustained Remission on Minimal Steroid Therapy (time frame: Baseline up to approximately 60 weeks). 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?
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 6 Jun 2019.