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CompletedNCT03651518PIMOCUpdated May 20, 2026

Personalized Therapies in Inflammatory Complex Disease

A Phase 2 interventional study of Kineret and Humira in Inflammatory Disease and Autoimmune Diseases, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Inflammatory Disease
  • Autoimmune Diseases

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Keywords

  • Personalized treatment
  • Inflammatory diseases
  • auto-inflammatory diseases
  • auto-immune diseases
  • Targeted treatments
  • skin
03

In context

Autoimmune Diseases

655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.

This study's enrollment of 32 is below the median of 40 across 427 interventional studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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, 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…)].

Exclusion criteria

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
  • 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)
    • 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 for doses greater than 5mg)
  • Patients with contra-indications to treatments : Severe or active infections including tuberculosis
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Kineret

    Drug: Kineret

  • Experimental
    Humira

    Drug: Humira

  • Experimental
    Stelara

    Drug: Stelara

  • Experimental
    Cosentyx

    Drug: Cosentyx

  • Experimental
    Roactemra

    Drug: Roactemra

  • Experimental
    Rituximab

    Drug: Rituximab

Interventions

  • DrugKineret

    100 mg, once/day sc 6 months

  • DrugHumira

    40 mg/15 days sc 6 months

  • DrugStelara

    45 mg/12 weeks sc, 6 months

  • DrugCosentyx

    300mg sc every week for 1 month, then 300 mg/month sc for 5 months

  • DrugRoactemra

    480 mg/perf/4 weeks 6 months

  • DrugRituximab

    2 sessions of 1000 mg at inclusion and 15 days after inclusion

06

What researchers measure

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)

    Time frame: 6 months

Secondary outcomes

  1. Number of Infections

    to evaluate tolerance

    Time frame: 12 months

  2. liver cell count toxicities

    to evaluate tolerance

    Time frame: 12 months

  3. kidney cell count toxicities

    to evaluate tolerance

    Time frame: 12 months

  4. blood cell count toxicities

    to evaluate tolerance

    Time frame: 12 months

  5. Change in Physician Global Assessment (PGA)

    to evaluate clinical efficiency

    Time frame: 1 month,

  6. Change in Physician Global Assessment (PGA)

    to evaluate clinical efficiency

    Time frame: 3 months,

  7. Change in Physician Global Assessment (PGA)

    to evaluate clinical efficiency

    Time frame: 6 months,

  8. Change in continuous PGA

    to evaluate clinical efficiency

    Time frame: 9 months

  9. Change in continuous PGA

    to evaluate clinical efficiency

    Time frame: 12 months

  10. Change in British Isles Lupus Assessment Group (BILAG)

    to evaluate clinical efficiency

    Time frame: 3 months

  11. Change in British Isles Lupus Assessment Group (BILAG)

    to evaluate clinical efficiency

    Time frame: 6 months

  12. Change in British Isles Lupus Assessment Group (BILAG)

    to evaluate clinical efficiency

    Time frame: 9 months

  13. Change in British Isles Lupus Assessment Group (BILAG)

    to evaluate clinical efficiency

    Time frame: 12 months

  14. Change in Systemic Lupus Erythematosus Responder Index (SRI)

    to evaluate clinical efficiency

    Time frame: 3 months

  15. Change in Systemic Lupus Erythematosus Responder Index (SRI)

    to evaluate clinical efficiency

    Time frame: 6 months

  16. Change in Systemic Lupus Erythematosus Responder Index (SRI)

    to evaluate clinical efficiency

    Time frame: 9 months

  17. Change in Systemic Lupus Erythematosus Responder Index (SRI)

    to evaluate clinical efficiency

    Time frame: 12 months

  18. Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)

    to evaluate clinical efficiency

    Time frame: 3 months

  19. Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)

    to evaluate clinical efficiency

    Time frame: 6 months

  20. Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)

    to evaluate clinical efficiency

    Time frame: 9 months

  21. Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)

    to evaluate clinical efficiency

    Time frame: 12 months

  22. Change in 36-Item Short Form Health Survey (SF36)

    to evaluate clinical efficiency

    Time frame: 3 months

  23. Change in 36-Item Short Form Health Survey (SF36)

    to evaluate clinical efficiency

    Time frame: 6 months

  24. Change in 36-Item Short Form Health Survey (SF36)

    to evaluate clinical efficiency

    Time frame: 9 months

  25. Change in 36-Item Short Form Health Survey (SF36)

    to evaluate clinical efficiency

    Time frame: 12 months

  26. Change in CRP

    to evaluate biological efficiency

    Time frame: 1 month

  27. Change in CRP

    to evaluate biological efficiency

    Time frame: 3 months

  28. Change in CRP

    to evaluate biological efficiency

    Time frame: 6 months

  29. Change in CRP

    to evaluate biological efficiency

    Time frame: 9 months

  30. Change in CRP

    to evaluate biological efficiency

    Time frame: 12 months

  31. Change in ESR (Erythrocyte sedimentation rate)

    to evaluate biological efficiency

    Time frame: 1 month

  32. Change in ESR (Erythrocyte sedimentation rate)

    to evaluate biological efficiency

    Time frame: 3 months

  33. Change in ESR (Erythrocyte sedimentation rate)

    to evaluate biological efficiency

    Time frame: 6 months

  34. Change in ESR (Erythrocyte sedimentation rate)

    to evaluate biological efficiency

    Time frame: 9 months

  35. Change in ESR (Erythrocyte sedimentation rate)

    to evaluate biological efficiency

    Time frame: 12 months

  36. Change in Fibrin

    to evaluate biological efficiency

    Time frame: 1 month,

  37. Change in Fibrin

    to evaluate biological efficiency

    Time frame: 3 months

  38. Change in Fibrin

    to evaluate biological efficiency

    Time frame: 6 months

  39. Change in Fibrin

    to evaluate biological efficiency

    Time frame: 9 months

  40. Change in Fibrin

    to evaluate biological efficiency

    Time frame: 12 months

  41. Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens

    to evaluate targeted biological efficiency

    Time frame: 1 month

  42. Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens

    to evaluate targeted biological efficiency

    Time frame: 3 months

  43. Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens

    to evaluate targeted biological efficiency

    Time frame: 6 months

  44. Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens

    to evaluate targeted biological efficiency

    Time frame: 12 months

  45. RNA analysis of targeted cytokines and RNA sequencing

    Time frame: 6 months

07

Study locations

1 site
  • Hôpital Cochin
    Paris, 75014, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03651518
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Aug 29, 2018
Start date
Oct 20, 2020
Primary completion
Nov 20, 2025
Completion
Nov 20, 2025
Last update
May 20, 2026

Study contacts

Selim ARACTINGI, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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