Inflammatory DiseasePhase 2PIMOCNCT03651518
Personalized Therapies in Inflammatory Complex Disease
A Phase 2 study testing Kineret, Humira and Stelara in people with Inflammatory Disease and Autoimmune Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Disease, Autoimmune Diseases
- What is being tested?
- Kineret, Humira and Stelara
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2020to 20 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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…)].
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Targeted Therapies in Inflammatory Complex Multi Organ Disease
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.
- Conditions
- Inflammatory Disease, Autoimmune Diseases
- Being tested
- Kineret, Humira, Stelara, Cosentyx, Roactemra
- Keywords
- Personalized treatment, Inflammatory diseases, auto-inflammatory diseases, auto-immune diseases, Targeted treatments, skin
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KineretDrug
100 mg, once/day sc 6 months
HumiraDrug
40 mg/15 days sc 6 months
StelaraDrug
45 mg/12 weeks sc, 6 months
CosentyxDrug
300mg sc every week for 1 month, then 300 mg/month sc for 5 months
RoactemraDrug
480 mg/perf/4 weeks 6 months
RituximabDrug
2 sessions of 1000 mg at inclusion and 15 days after inclusion
| Study group | Role | What they receive |
|---|---|---|
| Kineret | Experimental | Not described Receives: Drug: Kineret |
| Humira | Experimental | Not described Receives: Drug: Humira |
| Stelara | Experimental | Not described Receives: Drug: Stelara |
| Cosentyx | Experimental | Not described Receives: Drug: Cosentyx |
| Roactemra | Experimental | Not described Receives: Drug: Roactemra |
| Rituximab | Experimental | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (45)
Number of Infections
to evaluate tolerance
Measured: 12 months
liver cell count toxicities
to evaluate tolerance
Measured: 12 months
kidney cell count toxicities
to evaluate tolerance
Measured: 12 months
blood cell count toxicities
to evaluate tolerance
Measured: 12 months
Change in Physician Global Assessment (PGA)
to evaluate clinical efficiency
Measured: 1 month,
Change in Physician Global Assessment (PGA)
to evaluate clinical efficiency
Measured: 3 months,
Change in Physician Global Assessment (PGA)
to evaluate clinical efficiency
Measured: 6 months,
Change in continuous PGA
to evaluate clinical efficiency
Measured: 9 months
Change in continuous PGA
to evaluate clinical efficiency
Measured: 12 months
Change in British Isles Lupus Assessment Group (BILAG)
to evaluate clinical efficiency
Measured: 3 months
Change in British Isles Lupus Assessment Group (BILAG)
to evaluate clinical efficiency
Measured: 6 months
Change in British Isles Lupus Assessment Group (BILAG)
to evaluate clinical efficiency
Measured: 9 months
Change in British Isles Lupus Assessment Group (BILAG)
to evaluate clinical efficiency
Measured: 12 months
Change in Systemic Lupus Erythematosus Responder Index (SRI)
to evaluate clinical efficiency
Measured: 3 months
Change in Systemic Lupus Erythematosus Responder Index (SRI)
to evaluate clinical efficiency
Measured: 6 months
Change in Systemic Lupus Erythematosus Responder Index (SRI)
to evaluate clinical efficiency
Measured: 9 months
Change in Systemic Lupus Erythematosus Responder Index (SRI)
to evaluate clinical efficiency
Measured: 12 months
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)
to evaluate clinical efficiency
Measured: 3 months
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)
to evaluate clinical efficiency
Measured: 6 months
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)
to evaluate clinical efficiency
Measured: 9 months
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)
to evaluate clinical efficiency
Measured: 12 months
Change in 36-Item Short Form Health Survey (SF36)
to evaluate clinical efficiency
Measured: 3 months
Change in 36-Item Short Form Health Survey (SF36)
to evaluate clinical efficiency
Measured: 6 months
Change in 36-Item Short Form Health Survey (SF36)
to evaluate clinical efficiency
Measured: 9 months
Change in 36-Item Short Form Health Survey (SF36)
to evaluate clinical efficiency
Measured: 12 months
Change in CRP
to evaluate biological efficiency
Measured: 1 month
Change in CRP
to evaluate biological efficiency
Measured: 3 months
Change in CRP
to evaluate biological efficiency
Measured: 6 months
Change in CRP
to evaluate biological efficiency
Measured: 9 months
Change in CRP
to evaluate biological efficiency
Measured: 12 months
Change in ESR (Erythrocyte sedimentation rate)
to evaluate biological efficiency
Measured: 1 month
Change in ESR (Erythrocyte sedimentation rate)
to evaluate biological efficiency
Measured: 3 months
Change in ESR (Erythrocyte sedimentation rate)
to evaluate biological efficiency
Measured: 6 months
Change in ESR (Erythrocyte sedimentation rate)
to evaluate biological efficiency
Measured: 9 months
Change in ESR (Erythrocyte sedimentation rate)
to evaluate biological efficiency
Measured: 12 months
Change in Fibrin
to evaluate biological efficiency
Measured: 1 month,
Change in Fibrin
to evaluate biological efficiency
Measured: 3 months
Change in Fibrin
to evaluate biological efficiency
Measured: 6 months
Change in Fibrin
to evaluate biological efficiency
Measured: 9 months
Change in Fibrin
to evaluate biological efficiency
Measured: 12 months
Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens
to evaluate targeted biological efficiency
Measured: 1 month
Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens
to evaluate targeted biological efficiency
Measured: 3 months
Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens
to evaluate targeted biological efficiency
Measured: 6 months
Decreased in serum increased cytokines, in selected RNA in peripheral blood and skin specimens
to evaluate targeted biological efficiency
Measured: 12 months
RNA analysis of targeted cytokines and RNA sequencing
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start20 Oct 2020
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Selim ARACTINGI, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651518
- Sponsor's protocol ID
- P160906J
- Other IDs
- 2017-000519-18, 2017
- Acronym
- PIMOC
- Status last verified
- May 2026
- First submitted
- 25 Jun 2018
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Targeted Therapies in Inflammatory Complex Multi Organ Disease
- ClinicalTrials.gov ID
- NCT03651518
- Acronym / sponsor ID
- PIMOC / P160906J
- Conditions
- Inflammatory Disease, Autoimmune Diseases
- Keywords
- Personalized treatment, Inflammatory diseases, auto-inflammatory diseases, auto-immune diseases, Targeted treatments, skin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Kineret | Experimental | Drug: Kineret |
| Humira | Experimental | Drug: Humira |
| Stelara | Experimental | Drug: Stelara |
| Cosentyx | Experimental | Drug: Cosentyx |
| Roactemra | Experimental | Drug: Roactemra |
| Rituximab | Experimental | Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kineret100 mg, once/day sc 6 months | Drug | Kineret |
| Humira40 mg/15 days sc 6 months | Drug | Humira |
| Stelara45 mg/12 weeks sc, 6 months | Drug | Stelara |
| Cosentyx300mg sc every week for 1 month, then 300 mg/month sc for 5 months | Drug | Cosentyx |
| Roactemra480 mg/perf/4 weeks 6 months | Drug | Roactemra |
| Rituximab2 sessions of 1000 mg at inclusion and 15 days after inclusion | Drug | Rituximab |
Primary outcome
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)
45 secondary outcomes
Number of Infections
Time frame: 12 months
liver cell count toxicities
Time frame: 12 months
kidney cell count toxicities
Time frame: 12 months
blood cell count toxicities
Time frame: 12 months
Change in Physician Global Assessment (PGA)
Time frame: 1 month,
Change in Physician Global Assessment (PGA)
Time frame: 3 months,
Change in Physician Global Assessment (PGA)
Time frame: 6 months,
Change in continuous PGA
Time frame: 9 months
Change in continuous PGA
Time frame: 12 months
Change in British Isles Lupus Assessment Group (BILAG)
Time frame: 3 months
Change in British Isles Lupus Assessment Group (BILAG)
Time frame: 6 months
Change in British Isles Lupus Assessment Group (BILAG)
Time frame: 9 months
Change in British Isles Lupus Assessment Group (BILAG)
Time frame: 12 months
Change in Systemic Lupus Erythematosus Responder Index (SRI)
Time frame: 3 months
Change in Systemic Lupus Erythematosus Responder Index (SRI)
Time frame: 6 months
Change in Systemic Lupus Erythematosus Responder Index (SRI)
Time frame: 9 months
Change in Systemic Lupus Erythematosus Responder Index (SRI)
Time frame: 12 months
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)
Time frame: 3 months
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)
Time frame: 6 months
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)
Time frame: 9 months
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI)
Time frame: 12 months
Change in 36-Item Short Form Health Survey (SF36)
Time frame: 3 months
Change in 36-Item Short Form Health Survey (SF36)
Time frame: 6 months
Change in 36-Item Short Form Health Survey (SF36)
Time frame: 9 months
Change in 36-Item Short Form Health Survey (SF36)
Time frame: 12 months
Change in CRP
Time frame: 1 month
Change in CRP
Time frame: 3 months
Change in CRP
Time frame: 6 months
Change in CRP
Time frame: 9 months
Change in CRP
Time frame: 12 months
Change in ESR (Erythrocyte sedimentation rate)
Time frame: 1 month
Change in ESR (Erythrocyte sedimentation rate)
Time frame: 3 months
Change in ESR (Erythrocyte sedimentation rate)
Time frame: 6 months
Change in ESR (Erythrocyte sedimentation rate)
Time frame: 9 months
Change in ESR (Erythrocyte sedimentation rate)
Time frame: 12 months
Change in Fibrin
Time frame: 1 month,
Change in Fibrin
Time frame: 3 months
Change in Fibrin
Time frame: 6 months
Change in Fibrin
Time frame: 9 months
Change in Fibrin
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim ARACTINGI, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kineret, Humira and Stelara in people with Inflammatory Disease and Autoimmune Diseases, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite clinico-biological evaluation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.