PIMOC : Personalized targeted therapies in inflammatory complex multi organ disease

Phase 1

• Conditions: Patients presenting inflammatory non classified disease targeting at least 2 organs involvement: skin, lymph nodes, hemopoietic system, joints, digestive tract. The disease has been resistant to at least two prior lines of treatment.; MedDRA version: 20.0 Level: LLT Classification code 10062249 Term: Skin inflammation System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2017-000519-18-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

-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. 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 using SF36 assessment : score less than 30.
The disease has been resistant to at least two prior lines of treatment.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

-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
-Patients under legal protection
-Participation in another interventional trial
-Patients unable to respect the wash out delay of previously taken medications before inclusion time :
*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)
*Azathioprine (wash out period = 14 days)
*Mycophenolate mofetil (wash out period = 14 days)
*Disulone (wash out period = 7 days)
*Corticosteroids (=prednisone, prednisolone, dexamethasone, methylprednisolone) (wash out period = 7 days)
-Patients with contra-indications to treatments: Severe or active infections including tuberculosis

Importantly, in this study, the treatment will be selected by a committee depending on three criteria (cf Design of the trial: Interpretation of the data) including contra indications of the patients to the drugs. Therefore, contra indicated medications cannot be selected by the committee in view of protocol participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified