ArthritisMIMUTOXNCT03480529
Monitoring the IMmUological TOXicity of Drugs
An observational study of Arthritis and Systemic Lupus Erythematosus, run by Groupe Hospitalier Pitie-Salpetriere at 2 sites in France.
Trial summary
Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 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
- Arthritis, Systemic Lupus Erythematosus, Rheumatoid Arthritis
- What is being tested?
- drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom
- How many people
- 662 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2018to 10 Mar 2018
- How long will I take part?
- 1 Day
- 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 02/01/2018
- Adverse event reported were including the MedDRA terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome.
Who cannot join
- Chronology not compatible between the drug and the toxicity
Trial locations and contacts
2 sites in 1 country.
France2 sites
AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM.
Paris, 75013
Rhumatology department, CHU Strasbourg, Hautepierre hospital
Strasbourg, 67098
About this study
Several drugs and chemotherapies seem to have an impact on the immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 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 immunological system and are responsible of a wide range of rare immunological side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare immunological side effects (of which systemic lupus, immune arthritis, rheumatoid arthritis, Hepatitis, capillary leak syndrome) imputed to drugs. A causality assessment according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is systematically applied.
- Conditions
- Arthritis, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Capillary Leak Syndrome, Hepatitis
- Being tested
- drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom
- Keywords
- adverse event, arthritis, Systemic Lupus Erythematosus, Capillary Leak Syndrome, Hepatitis
- Medical subject headings
- Arthritis, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid, Capillary Leak Syndrome, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug inducing arthritis, lupus, hepatitis, or capillary leak syndromDrug
Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom
| Study group | Role | What they receive |
|---|---|---|
| Arthritis or lupus or CLS induced by a drug | Case reported in the World Health Organization (WHO) of arthritis or lupus, or Hepatitis, or capillary leak syndrome of patient treated by a drug, with a chronology compatible with the drug toxicity Receives: Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms:
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Secondary outcomes (7)
Causality assessment of reported arthritis, hepatitis, or lupus events according to the WHO system
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the type of arthritis or lupus or hepatitis or capillary leak syndrom depending on the category of drug
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the other immune related adverse events concomitant to the arthritis or lupus or hepatitis or capillary leak syndrom induced by drugs
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the drug-drug interactions associated with adverse events
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the population of patients having a arthritis or lupus or hepatitis or CLS adverse event
Measured: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Mar 2018
- Primary completion10 Mar 2018
- Study completion10 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies 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
- 662 participants (actual)
- Target duration
- 1 Day
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
- NCT03480529
- Sponsor's protocol ID
- CIC1421-18-05
- Acronym
- MIMUTOX
- Status last verified
- Sep 2019
- First submitted
- 21 Mar 2018
- Last updated
- 4 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arnaud L, Lebrun-Vignes B, Salem JE. Checkpoint inhibitor-associated immune arthritis. Ann Rheum Dis. 2019 Jul;78(7):e68. doi: 10.1136/annrheumdis-2018-213470. Epub 2018 May 3. No abstract available.
PubMed 29724725Mertz P, Lebrun-Vignes B, Salem JE, Arnaud L. Characterizing drug-induced capillary leak syndromes using the World Health Organization VigiBase. J Allergy Clin Immunol. 2019 Jan;143(1):433-436. doi: 10.1016/j.jaci.2018.09.001. Epub 2018 Sep 20. No abstract available.
PubMed 30244023Arnaud L, Mertz P, Gavand PE, Martin T, Chasset F, Tebacher-Alt M, Lambert A, Muller C, Sibilia J, Lebrun-Vignes B, Salem JE. Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database. Ann Rheum Dis. 2019 Apr;78(4):504-508. doi: 10.1136/annrheumdis-2018-214598. Epub 2019 Feb 4.
PubMed 30793701
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring the IMmUological TOXicity of Drugs
- ClinicalTrials.gov ID
- NCT03480529
- Acronym / sponsor ID
- MIMUTOX / CIC1421-18-05
- Conditions
- Arthritis, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Capillary Leak Syndrome, Hepatitis
- Keywords
- adverse event, arthritis, Systemic Lupus Erythematosus, Capillary Leak Syndrome, Hepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 10 Mar 2018 (actual)
- Study completion
- 10 Mar 2018 (actual)
- First posted
- 29 Mar 2018 (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 immunological system. This study investigates reports of immunological toxicities, including the International classification of disease ICD-10 codes M05, M32, I78 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 immunological system and are responsible of a wide range of rare immunological side effects. Those are poorly described, due to the modification of the pharmacopeia, and the recent recognition of several of these adverse events. This study investigates the main characteristics of patients affected by rare immunological side effects (of which systemic lupus, immune arthritis, rheumatoid arthritis, Hepatitis, capillary leak syndrome) imputed to drugs. 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 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthritis or lupus or CLS induced by a drug | – | Drug: drug inducing arthritis, lupus, hepatitis, or capillary leak syndromCase reported in the World Health Organization (WHO) of arthritis or lupus, or Hepatitis, or capillary leak 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 (2 listed)
- Case reported in the WHO's pharmacovigilance database till 02/01/2018
- Adverse event reported were including the MedDRA terms for immune arthritis, systemic lupus erythematosus, hepatitis, rheumatoid arthritis and capillary leak syndrome.
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 arthritis, lupus, hepatitis, or capillary leak syndromDrugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom | Drug | Arthritis or lupus or CLS induced by a drug |
Primary outcome
Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms:
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
7 secondary outcomes
Causality assessment of reported arthritis, hepatitis, or lupus events according to the WHO system
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the type of arthritis or lupus or hepatitis or capillary leak syndrom depending on the category of drug
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the other immune related adverse events concomitant to the arthritis or lupus or hepatitis or capillary leak syndrom induced by drugs
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the duration of treatment when the toxicity happens (role of cumulative dose)
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the drug-drug interactions associated with adverse events
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
Description of the population of patients having a arthritis or lupus or hepatitis or CLS adverse event
Time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018
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 4 Sep 2019.
- Results publication: PubMed 29724725Arnaud L, Lebrun-Vignes B, Salem JE. Checkpoint inhibitor-associated immune arthritis. Ann Rheum Dis. 2019 Jul;78(7):e68. doi: 10.1136/annrheumdis-2018-213470. Epub 2018 May 3. No abstract available.
- Results publication: PubMed 30244023Mertz P, Lebrun-Vignes B, Salem JE, Arnaud L. Characterizing drug-induced capillary leak syndromes using the World Health Organization VigiBase. J Allergy Clin Immunol. 2019 Jan;143(1):433-436. doi: 10.1016/j.jaci.2018.09.001. Epub 2018 Sep 20. No abstract available.
- Results publication: PubMed 30793701Arnaud L, Mertz P, Gavand PE, Martin T, Chasset F, Tebacher-Alt M, Lambert A, Muller C, Sibilia J, Lebrun-Vignes B, Salem JE. Drug-induced systemic lupus: revisiting the ever-changing spectrum of the disease using the WHO pharmacovigilance database. Ann Rheum Dis. 2019 Apr;78(4):504-508. doi: 10.1136/annrheumdis-2018-214598. Epub 2019 Feb 4.
- Individual participant dataSharing planned: No
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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.
2 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 and Systemic Lupus Erythematosus, run by Groupe Hospitalier Pitie-Salpetriere at 2 sites 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 2 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 4 Sep 2019. 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 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?
Arthritis, hepatitis, and lupus induced toxicity of Immune Checkpoint inhibitors (ICI) Identification and report of cases of arthritis or lupus associated with ICIs. The research includes the report with MedDRA terms: (time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 02/01/2018). 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 NCT03480529, which also lists 3 linked publications.
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 4 Sep 2019.