Rheumatoid Arthritis Clinical Trial
— TRANSREGOfficial title:
Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach
Verified date | July 2021 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. Extensive biological- and immune-monitoring pre- and post-IL2 will contribute (i) to define the common or distinct processes responsible for the breakdown of immunological tolerance in these pathologies and (ii) to discover potential biomarkers of the IL2 response.
Status | Completed |
Enrollment | 81 |
Est. completion date | April 1, 2021 |
Est. primary completion date | October 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age > 18 year - male or female - documented diagnosis of one AIID among the 14 diseases selected (following consensual specific criteria) - stable or moderately active disease (except Lupus) under standard treatment (= 2 months) at the time of inclusion (except Sclerosing Cholangitis, Gougerot-sjögren, Takayasu's Disease and Systemic Sclerosis) - normal thyroid function (with or without treatment) - effective contraception for more than two weeks at inclusion and negative beta HCG test for women of childbearing potential, - affiliated to the social security system - written informed consent form. Exclusion Criteria: - known intolerance for IL2 (see SPC), - administration of a non-authorized treatment and/or IV bolus of corticosteroids in the last 2 months, - vaccination with live attenuated virus in the months preceding the inclusion or planned during the study - other severe or progressive autoimmune/inflammatory pathology, - low white blood cell count<2000/mm3, lymphocytes <600/mm3, platelets <80 000/mm3, - heart failure (= grade III NYHA), renal insufficiency (Cockcroft< 60ml/mn except patients with lupus or Wegener's granulomatosis) or hepatic insufficiency (transaminases> 5N except for patients with autoimmune hepatitis), or lung failure, - significant abnormality in chest X-ray other than these linked to the diseases under investigation - cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or basocellular carcinoma) - poor venous access not allowing repeated blood tests, - restrictive diet or parenteral nutrition, - surgery during the last 2 months or surgery planned during the study, - participation in other biomedical research in the last 3 months or planned during the study. - pregnant or lactating women, - concomitant psychiatric disease or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give informed consent, - positive HIV serology, active hepatitis B or EBV infection, - patients under a measure of legal protection |
Country | Name | City | State |
---|---|---|---|
France | Henri Mondor - Médecine Interne | Créteil | |
France | CIC - Hôpital PITIE SALPETRIERE | Paris | Ile De France |
France | Médecine interne - Hôpital Saint-Antoine | Paris | |
France | Service d' Hépato Gastro Entérologie - Hôpital SAINT-ANTOINE | Paris | Ile De France |
France | Service de Dermatologie - Hôpital COCHIN | Paris | Ile De France |
France | Service de Gastro Entérologie - Hôpital SAINT-ANTOINE | Paris | Ile De France |
France | Service de Médecine Interne - Hôpital PITIE SALPETRIERE | Paris | Ile De France |
France | Service de médecine vasculaire - HEGP | Paris | |
France | Service de Rhumatologie - Hôpital PITIE SALPETRIERE | Paris | Ile De France |
France | Service de Rhumatologie - Hôpital SAINT-ANTOINE | Paris | Ile De France |
France | Centre Hépato-Biliaire - Hôpital Paul Brousse | Villejuif | Ile De France |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Iltoo Pharma |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentages of Tregs | Change in Treg percentage (percentages of Tregs within the CD4+ lymphocytes) at Day-8 after administration of low-dose of IL2 compared to baseline (Day0) | Day8 | |
Secondary | Percentages of Tregs | Changes in Treg percentage at Day 15, 29, 85, 183, 240, 360 and 540 compared to baseline (Day0) | Day 15, 29, 85, 183, 240, 360 and 540 | |
Secondary | inflammation markers (CRP and CRP ultra sensible) | Changes in levels of inflammation markers | Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540 | |
Secondary | markers of inflammatory anemia (Hemoglobin, serum iron level, transferrin) ferritin | Changes in levels of inflammation markers | Day 0, 1, 8, 15, 29, 85, 183, 240, 360 and 540 | |
Secondary | Number of relapses | up to Day540 | ||
Secondary | CGI-sev, CGI-activity and CGI-eff scales | Change in the clinical global impression severity and efficacy scale (CGI-sev, CGI-act and CGI-eff scales) at Day 85, 183, 240, 360 and 540 compared to baseline (Day1) | Day 85, 183, 240, 360 and 540 | |
Secondary | EuroQL-5 scale | Change in the quality of life (EuroQL-5 scale) | Day 183 | |
Secondary | Evolution of clinical, biological or radiological criteria specific to each disease | Changes in disease-specific score and/or evolution of clinical, biological or radiological criteria specific to each disease | up to Day 540 | |
Secondary | Safety Assessment | Safety Assessment all along the observation period (Day-1 to Day-240): Safety assessment will include vital signs, adverse events and concomitant medications collection as well as biology during the 6 months of the treatment period; .In addition, the evolution of the disease will be followed up to 1 year after IL2- treatment stop. | up to Day 540 |
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