Personalized Therapies in Inflammatory Complex Disease

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT03651518
Phase
PHASE2
Status
Completed

Conditions

  • Autoimmune Diseases
  • Inflammatory Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kineret — DRUG
    100 mg, once/day sc 6 months
  • Humira — DRUG
    40 mg/15 days sc 6 months
  • Stelara — DRUG
    45 mg/12 weeks sc, 6 months
  • Cosentyx — DRUG
    300mg sc every week for 1 month, then 300 mg/month sc for 5 months
  • Roactemra — DRUG
    480 mg/perf/4 weeks 6 months
  • Rituximab — DRUG
    2 sessions of 1000 mg at inclusion and 15 days after inclusion

Study Details

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

Key Dates

Start date
Oct 20, 2020
Status verified
May 2026
Primary completion
Nov 20, 2025
Completion
Nov 20, 2025

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Kineret
  • Experimental: Humira
  • Experimental: Stelara
  • Experimental: Cosentyx
  • Experimental: Roactemra
  • Experimental: Rituximab

Primary Outcome Measure

Composite clinico-biological evaluation [ Time Frame: 6 months ]

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