Personalized Therapies in Inflammatory Complex Disease
PIMOC
Personalized Targeted Therapies in Inflammatory Complex Multi Organ Disease
2 other identifiers
interventional
32
1 country
1
Brief Summary
Inflammatory diseases may display atypical features making such patients impossible to classify. Management of these cases in daily practice cannot rely on the results of clinical trials nor on guidelines. DNA and RNA mapping have become major tools to understand and sometimes direct the treatment strategy in oncology. This study aims to test whether a precise analysis of molecular pathways in inflammatory, non classified diseases, can constitute a predictive tool of therapeutic efficiency
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2020
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedNovember 20, 2025
October 1, 2025
5 years
June 25, 2018
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite clinico-biological evaluation
Response will be assessed at month 6 with a composite endpoint defined as improvement of at least of 2 of the 3 following parameters: * 50% improvement of the systemic activity assessed by the clinician following a visual analog scale (0-10), where clinician will be asked the following question: "Please indicate, according to your clinical experience and taking into account all systemic manifestations, the level of disease activity in this patient using the following scale:" * and/or 50% improvement of cutaneous activity assessed by the involved skin surface area (according the rule of 9%). Standardised skin pictures will be done in order to centrally review cutaneous response. * and/or 50% decrease or normalisation of biological markers of inflammation (either CRP, ESR or fibrin)
6 months
Secondary Outcomes (45)
Number of Infections
12 months
liver cell count toxicities
12 months
kidney cell count toxicities
12 months
blood cell count toxicities
12 months
Change in Physician Global Assessment (PGA)
1 month,
- +40 more secondary outcomes
Study Arms (6)
Kineret
EXPERIMENTALHumira
EXPERIMENTALStelara
EXPERIMENTALCosentyx
EXPERIMENTALRoactemra
EXPERIMENTALRituximab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients (men or women) aged 18 years old and over
- Patients presenting inflammatory non classified disease targeting at least 2 organs involvement: skin, lymph nodes, hemopoietic system, joints, digestive tract, eye, nerves and brain tissues, respiratory tract, cardio-vascular disorders, genito-urinary tract including kidney, musculo-skeletal tissues. Skin involvement is mandatory in order to be able to compare involved and non-involved tissue
- Signed informed consent
- The disease should be considered as non-classified despite classical and adapted investigations and evaluation through expert committee meeting.
- The disease alters significantly quality of life. The impairment of quality of life will be assessed based on the investigator's assessment.
- The disease has been resistant to at least two prior lines of treatment \[for example : Hydroxychloroquine, Chloroquine, Colchicine, Methotrexate, Ciclosporine, Azathioprine, Mycophenolate mofetil, Disulone, Corticosteroids (prednisone, prednisolone, dexamethasone, methylprednisolone…)\].
You may not qualify if:
- Patients presenting disease which is not featured by lesional and healthy skin areas, easy to biopsy
- Patients refusing biopsies
- Pregnancy
- Women of child-bearing potential unable to receive highly efficient contraception such as combined oral contraceptives, intra-uterine disposals, hormonal implants or the use of male condoms recommended in case of unstable or irregular partner or as a replacement method for transient unacessebility to hormonal method
- Breastfeeding
- Patients presenting disease needing urgent therapeutic measures
- Patients without health insurance or social security
- Participation in another interventional trial
- Patients under legal protection
- Patients unable to respect the wash out delay of previously taken medications before biopsy and before treatment initiation :
- Hydroxychloroquine (wash out period = 30 days)
- Chloroquine (wash out period = 7 days)
- Colchicine (wash out period = 7 days)
- Methotrexate (wash out period = 7 days)
- Ciclosporine (wash out period = 14 days)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Cochin
Paris, 75014, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Selim ARACTINGI, PhD
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2018
First Posted
August 29, 2018
Study Start
October 20, 2020
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
November 20, 2025
Record last verified: 2025-10