An observational study in Arthritis, Cancer and Cardiac Disease, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational
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Among 70 studies in Arthritis with a site in France — 9 open to participants now, 16 under way, 4 of them phase 3. Arthritis · France.
Among the 70 studies in Arthritis with a site in France, this one is the 2nd largest by enrollment of the 31 observational ones that give a count, is one of 7 that started in 2018, is one of 31 observational ones, and was the 40th registered.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
Browse Arthritis studies →9 of the 70 studies in Arthritis with a site in France are open now. Recruiting first, the newest first:
Centre Hospitalier Universitaire, Amiens · Sites in France
Ages 2–16
University Hospital, Brest · Sites in France
Ages 18+
Medacta International SA · Sites in France
Ages 18–65
AstraZeneca · Sites in France, United States, Canada and 7 more countries
Ages 18–70
UCB Biopharma SRL · Sites in France, Canada, Germany and 3 more countries
Ages 2–18
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 78 Arthritis studies recruiting now, 41 (53%) set no upper age limit and 20 (26%) stop at 75 or younger; 16 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
70 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 5 · Phase 3 22 · Phase 4 4
First in 2000; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,000 is above the median of 151 across 202 observational studies indexed under Arthritis.
Median enrollment 220 across the 39 interventional studies, 201 across the 31 observational. Of the 45 that completed or were terminated, 22 (49%) have results posted.
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42 of 70 have an industry lead sponsor. The 10 most frequent:
Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 66 studies on the registry; 4 are open to participants now.
Groupe Hospitalier Pitie-Salpetriere has 3 studies filed under Arthritis — fewer than ten, so there is no comparison to draw.
4 of the studies in Arthritis with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05658575Phase 3Olatec Therapeutics, Inc.Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare | 2026-12-31 |
| NCT02337244Zimmer, GmbHZimmer POLAR Persona - TKA (EMEA Study) | 2026-12 |
| NCT03372278Zimmer BiometPMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty | 2027-01 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
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Among the 70 studies in Arthritis with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Immune checkpoint inhibitors (ICIs) might have high grade immune-related adverse events (irAEs) from rhumatologic, endocrinologic, cardiac or other system origin. This study investigates reports of drug induced irAEs with treatment including anti-PD1, Anti-PDL-1, and Anti-CTLA4 classes using the World Health Organization (WHO) database VigiBase and the french database Base Nationale de PharmacoVigilance (BNPV).
Immune checkpoint inhibitors (ICIs) have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, immune-related adverse events (irAEs) can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, and in the Base Nationale de PharmacoVigilance (BNPV) which is the french pharmacovigilance database, to identify cases of adverse drug reaction including arthiritis, auto-immune induced diseases, cardiac diseases, endocrinologic diseases, following treatment with ICIs.
Patients treated with an ICI for a cancer
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Exclusion Criteria:
Case reported in the World Health Organization (WHO) and the Base Nationale de PharmacoVigilance of patient treated by ICI, with a chronology compatible with the drug toxicity
Drug: Immune checkpoint inhibitor
Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification) as a monotherapy or in combination: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
This study also gives Pembrolizumab, Nivolumab, Ipilimumab, Durvalumab, Atezolizumab. No intervention listed here names it: that was found by reading the record.
Adverse drug reactions induced by ICIs and reported in the World Health Organization (WHO) or the Base Nationale de Pharmacovigilance (BNPV)
Identification and report of cases of adverse events associated with ICIs. Drugs investigated are ICIs: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018
Causality assessment of reported adverse drug reaction according to the WHO system
Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018
Description of the type of adverse drug reaction depending on the category of ICIs
Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018
Description of the other immune related adverse events concomitant to the adverse drug reaction induced by ICIs
Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018
Description of the drug-drug interactions associated with adverse events
Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018
Description of the population of patients having adverse event
Time frame: Case reported in the World Health Organization (WHO) or BNPV database of individual safety case reports to May 2018
Plan to share: Undecided
Ran from Feb 2018 to primary completion in Sep 2018, 7 months.
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Groupe Hospitalier Pitie-Salpetriere