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Personalized Therapies in Inflammatory Complex Disease (PIMOC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651518
Recruitment Status : Not yet recruiting
First Posted : August 29, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Inflammatory Disease Autoimmune Diseases Drug: Kineret Drug: Humira Drug: Stelara Drug: Cosentyx Drug: Roactemra Drug: Rituximab Phase 2

Detailed Description:

This is a phase IIb study. The main objective of this study is to evaluate the efficacy of targeted treatments in patients displaying a non-classified, severe and resistant inflammatory disease. Targeted treatments for each patient will have been selected through an algorithm based on molecular analysis of specific altered inflammatory signaling pathway.

Treatments consist in targeted therapies approved in other indications (Kineret®, Humira®, Stelara®, Cosentyx®, Roactemra® and Rituximab®) that will be given once selected using molecular analysis and decision making procedure by the Scientific committee.

For each patient, one targeted treatment will be administered according to the SmPC procedure for a treatment period of 6 months.

Primary efficacy endpoint:

Response will be assessed at month 6 with a composite endpoint defined as improvement of at least 2 of the 3 following parameters:

  • 50% improvement of the systemic activity assessed by the clinician following a visual analog scale (0-10 mm),
  • and/or 50% improvement of cutaneous activity assessed by the involved skin surface area,
  • and/or 50% decrease or normalisation of biological markers of inflammation (either CRP, ESR or fibrin).

An independent adjudication committee blinded to the treatment received, will review primary endpoint for all patients based on clinical files and standardized photographs, to validate the response.

Other secondary criteria will be assessed. Overall, this study will require a molecular analysis done on patient's tissue, the final aim being to evaluate efficiency and tolerance of targeted treatments chosen in a personalized analysis when classification is impossible.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Targeted Therapies in Inflammatory Complex Multi Organ Disease
Estimated Study Start Date : March 15, 2019
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : September 15, 2021

Arm Intervention/treatment
Experimental: Kineret Drug: Kineret
100 mg, once/day sc 6 months

Experimental: Humira Drug: Humira
40 mg/15 days sc 6 months

Experimental: Stelara Drug: Stelara
45 mg/12 weeks sc, 6 months

Experimental: Cosentyx Drug: Cosentyx
300mg sc every week for 1 month, then 300 mg/month sc for 5 months

Experimental: Roactemra Drug: Roactemra
480 mg/perf/4 weeks 6 months

Experimental: Rituximab Drug: Rituximab
2 sessions of 1000 mg at inclusion and 15 days after inclusion




Primary Outcome Measures :
  1. Composite clinico-biological evaluation [ Time Frame: 6 months ]

    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)


Secondary Outcome Measures :
  1. Number of Infections [ Time Frame: 12 months ]
    to evaluate tolerance

  2. liver cell count toxicities [ Time Frame: 12 months ]
    to evaluate tolerance

  3. kidney cell count toxicities [ Time Frame: 12 months ]
    to evaluate tolerance

  4. blood cell count toxicities [ Time Frame: 12 months ]
    to evaluate tolerance

  5. Change in Physician Global Assessment (PGA) [ Time Frame: 1 month, ]
    to evaluate clinical efficiency

  6. Change in Physician Global Assessment (PGA) [ Time Frame: 3 months, ]
    to evaluate clinical efficiency

  7. Change in Physician Global Assessment (PGA) [ Time Frame: 6 months, ]
    to evaluate clinical efficiency

  8. Change in continuous PGA [ Time Frame: 9 months ]
    to evaluate clinical efficiency

  9. Change in continuous PGA [ Time Frame: 12 months ]
    to evaluate clinical efficiency

  10. Change in British Isles Lupus Assessment Group (BILAG) [ Time Frame: 3 months ]
    to evaluate clinical efficiency

  11. Change in British Isles Lupus Assessment Group (BILAG) [ Time Frame: 6 months ]
    to evaluate clinical efficiency

  12. Change in British Isles Lupus Assessment Group (BILAG) [ Time Frame: 9 months ]
    to evaluate clinical efficiency

  13. Change in British Isles Lupus Assessment Group (BILAG) [ Time Frame: 12 months ]
    to evaluate clinical efficiency

  14. Change in Systemic Lupus Erythematosus Responder Index (SRI) [ Time Frame: 3 months ]
    to evaluate clinical efficiency

  15. Change in Systemic Lupus Erythematosus Responder Index (SRI) [ Time Frame: 6 months ]
    to evaluate clinical efficiency

  16. Change in Systemic Lupus Erythematosus Responder Index (SRI) [ Time Frame: 9 months ]
    to evaluate clinical efficiency

  17. Change in Systemic Lupus Erythematosus Responder Index (SRI) [ Time Frame: 12 months ]
    to evaluate clinical efficiency

  18. Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) [ Time Frame: 3 months ]
    to evaluate clinical efficiency

  19. Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) [ Time Frame: 6 months ]
    to evaluate clinical efficiency

  20. Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) [ Time Frame: 9 months ]
    to evaluate clinical efficiency

  21. Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) [ Time Frame: 12 months ]
    to evaluate clinical efficiency

  22. Change in 36-Item Short Form Health Survey (SF36) [ Time Frame: 3 months ]
    to evaluate clinical efficiency

  23. Change in 36-Item Short Form Health Survey (SF36) [ Time Frame: 6 months ]
    to evaluate clinical efficiency

  24. Change in 36-Item Short Form Health Survey (SF36) [ Time Frame: 9 months ]
    to evaluate clinical efficiency

  25. Change in 36-Item Short Form Health Survey (SF36) [ Time Frame: 12 months ]
    to evaluate clinical efficiency

  26. Change in CRP [ Time Frame: 1 month ]
    to evaluate biological efficiency

  27. Change in CRP [ Time Frame: 3 months ]
    to evaluate biological efficiency

  28. Change in CRP [ Time Frame: 6 months ]
    to evaluate biological efficiency

  29. Change in CRP [ Time Frame: 9 months ]
    to evaluate biological efficiency

  30. Change in CRP [ Time Frame: 12 months ]
    to evaluate biological efficiency

  31. Change in ESR (Erythrocyte sedimentation rate) [ Time Frame: 1 month ]
    to evaluate biological efficiency

  32. Change in ESR (Erythrocyte sedimentation rate) [ Time Frame: 3 months ]
    to evaluate biological efficiency

  33. Change in ESR (Erythrocyte sedimentation rate) [ Time Frame: 6 months ]
    to evaluate biological efficiency

  34. Change in ESR (Erythrocyte sedimentation rate) [ Time Frame: 9 months ]
    to evaluate biological efficiency

  35. Change in ESR (Erythrocyte sedimentation rate) [ Time Frame: 12 months ]
    to evaluate biological efficiency

  36. Change in Fibrin [ Time Frame: 1 month, ]
    to evaluate biological efficiency

  37. Change in Fibrin [ Time Frame: 3 months ]
    to evaluate biological efficiency

  38. Change in Fibrin [ Time Frame: 6 months ]
    to evaluate biological efficiency

  39. Change in Fibrin [ Time Frame: 9 months ]
    to evaluate biological efficiency

  40. Change in Fibrin [ Time Frame: 12 months ]
    to evaluate biological efficiency

  41. Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens [ Time Frame: 1 month ]
    to evaluate targeted biological efficiency

  42. Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens [ Time Frame: 3 months ]
    to evaluate targeted biological efficiency

  43. Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens [ Time Frame: 6 months ]
    to evaluate targeted biological efficiency

  44. Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens [ Time Frame: 12 months ]
    to evaluate targeted biological efficiency

  45. RNA analysis of targeted cytokines and RNA sequencing [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Patients presenting disease which is not featured by lesional and healthy skin areas, easy to biopsy
  • Patients refusing biopsies
  • Pregnancy
  • Breastfeeding
  • Patients presenting disease needing urgent therapeutic measures
  • Patients without health insurance or social security
  • Participation in another trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651518


Contacts
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Contact: Selim ARACTINGI, PhD + 33 1 58 41 19 88 selim.aractingi@gmail.com
Contact: Christelle AUGER + 33 1 58 41 11 86 christelle.auger@aphp.fr

Locations
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France
Hôpital Cochin
Paris, France, 75014
Contact: selim ARACTINGI, PhD    + 33 1 58 41 19 88    selim.aractingi@gmail.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Selim ARACTINGI, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03651518    
Other Study ID Numbers: P160906J
2017-000519-18 ( Registry Identifier: ID-RCB )
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Personalized treatment
Inflammatory diseases
auto-inflammatory diseases
auto-immune diseases
Targeted treatments
skin
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases
Rituximab
Interleukin 1 Receptor Antagonist Protein
Ustekinumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents