Antiphospholipid SyndromeAPSTOXNCT03994302
Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
An observational study of Antiphospholipid Syndrome and Immune Disease, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
Trial summary
Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Syndrome, Immune Disease, Adverse Drug Event
- What is being tested?
- Drug inducing antiphospholipid syndrome
- How many people
- 2,700 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 8 Apr 2023
- How long will I take part?
- 1 Year
- 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: Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
Who may be able to join
- Case reported in the WHO's pharmacovigilance database till 01/06/2019
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
1 site in 1 country.
France1 site
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM
Paris, 75013
About this study
Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Read the detailed description
Several drugs and chemotherapies seem to have an impact on the immune system and are responsible of a wide range of immune side effects such as antiphospholipid syndrome. Those are poorly described, due to the modificationof the pharmacopeia, and the recent recognition of several of these adverseevents.
This study investigates the main characteristics of patients affected by immune side effects imputed to drugs in particular antiphospholipid syndrome.
A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.
- Being tested
- Drug inducing antiphospholipid syndrome
- Medical subject headings
- Antiphospholipid Syndrome, Immune System Diseases, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug inducing antiphospholipid syndromeDrug
Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome
| Study group | Role | What they receive |
|---|---|---|
| Immune toxicity induced by drugs and chemotherapies | Immune toxicity induced by drugs and chemotherapies Case reported in the World Health Organization (WHO) of immune toxicities(such as Antiphospholipid syndrome) of patient treated by a drug, with a chronology compatible with the drug toxicity Receives: Drug: Drug inducing antiphospholipid syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.
Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: 01/06/2019
Secondary outcomes (7)
Causality assessment of reported metabolic toxicities events according to the WHO system Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: 01/06/2019
Description of the type of immune toxicity depending on the category of drug Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: 01/06/2019
Description of the other immune related adverse events concomitant to the immune toxicity induced by drugs Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: 01/06/2019
Description of the duration of treatment when the toxicity happens (role of cumulative dose) Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: 01/06/2019
Description of the drug-drug interactions associated with adverse events Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: 01/06/2019
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: 01/06/2019
Description of the population of patients having hematological toxicity adverse event Case reported in the World Health Organization (WHO) database of individual safety case reports
Measured: 01/06/2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start1 Jun 2019
- Primary completion30 Jun 2021
- Study completion8 Apr 2023
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 Antiphospholipid SyndromeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 2,700 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Elie Salem, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994302
- Sponsor's protocol ID
- CIC1421-19-10
- Acronym
- APSTOX
- Status last verified
- Apr 2023
- First submitted
- 19 Jun 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gerardin C, Bihan K, Salem JE, Khachatryan H, Gerotziafas G, Fain O, Mekinian A. Drug-induced antiphospholipid syndrome: Analysis of the WHO international database. Autoimmun Rev. 2022 May;21(5):103060. doi: 10.1016/j.autrev.2022.103060. Epub 2022 Feb 1.
PubMed 35114404
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
- ClinicalTrials.gov ID
- NCT03994302
- Acronym / sponsor ID
- APSTOX / CIC1421-19-10
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,700 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 8 Apr 2023 (actual)
- First posted
- 21 Jun 2019 (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.
Several drugs and chemotherapies seem to have an impact on the immune system. This study investigates reports of immune toxicities such as antiphospholipid syndrome, including the International classification of disease ICD-10 for treatments in the World Health Organization (WHO) global Individual Case Safety Report (ICSR) database (VigiBase).
Detailed description
Several drugs and chemotherapies seem to have an impact on the immune system and are responsible of a wide range of immune side effects such as antiphospholipid syndrome. Those are poorly described, due to the modificationof the pharmacopeia, and the recent recognition of several of these adverseevents.
This study investigates the main characteristics of patients affected by immune side effects imputed to drugs in particular antiphospholipid syndrome.
A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immune toxicity induced by drugs and chemotherapies | – | Drug: Drug inducing antiphospholipid syndromeImmune toxicity induced by drugs and chemotherapies Case reported in the World Health Organization (WHO) of immune toxicities(such as Antiphospholipid syndrome) of patient treated by a drug, with a chronology compatible with the drug toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with a drug that could be reported in the WHO's pharmacovigilance database
Key inclusion criteria (1 listed)
- Case reported in the WHO's pharmacovigilance database till 01/06/2019
Key exclusion criteria (1 listed)
- Chronology not compatible between the drug and the toxicity
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 |
|---|---|---|
| Drug inducing antiphospholipid syndromeDrugs susceptible to induce immune toxicities such as antiphospholipid syndrome | Drug | Immune toxicity induced by drugs and chemotherapies |
Primary outcome
Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs.
Time frame: 01/06/2019
Case reported in the World Health Organization (WHO) database of individual safety case reports
7 secondary outcomes
Causality assessment of reported metabolic toxicities events according to the WHO system Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: 01/06/2019
Description of the type of immune toxicity depending on the category of drug Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: 01/06/2019
Description of the other immune related adverse events concomitant to the immune toxicity induced by drugs Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: 01/06/2019
Description of the duration of treatment when the toxicity happens (role of cumulative dose) Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: 01/06/2019
Description of the drug-drug interactions associated with adverse events Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: 01/06/2019
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: 01/06/2019
Description of the population of patients having hematological toxicity adverse event Case reported in the World Health Organization (WHO) database of individual safety case reports
Time frame: 01/06/2019
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 2023.
- Derived from this study: PubMed 35114404Gerardin C, Bihan K, Salem JE, Khachatryan H, Gerotziafas G, Fain O, Mekinian A. Drug-induced antiphospholipid syndrome: Analysis of the WHO international database. Autoimmun Rev. 2022 May;21(5):103060. doi: 10.1016/j.autrev.2022.103060. Epub 2022 Feb 1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome and Immune Disease, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
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 1 inclusion and 1 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 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Immune toxicities (such as Antiphospholipid Syndrome) of drugs Identification and report of immune toxicities associated with drugs. (time frame: 01/06/2019). 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 NCT03994302, 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 2023.