Molecular map may guide treatment for mysterious inflammatory illnesses
NCT ID NCT03651518
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether analyzing a patient's DNA and RNA could help doctors pick the right drug for inflammatory diseases that don't fit standard categories. 32 adults with at least two affected organs (including skin) received one of six targeted therapies based on their molecular profile. The goal was to see if this personalized approach could improve symptoms and reduce inflammation at 6 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Kineret, Humira, Stelara, Cosentyx, Roactemra, Rituximab
- What this could lead to
- If successful, this approach could help doctors choose the right drug for patients with rare or hard-to-classify inflammatory diseases, improving treatment outcomes.
- What could go wrong
- This was a small, early-phase study (32 people) without a control group, so results may not apply broadly. The molecular analysis method may not reliably predict drug response.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
32 people
The number who actually took part.
- Started
-
Oct 2020
- Finished
-
Nov 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hôpital Cochin
Paris, 75014, France
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