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Clinical Trials/EUCTR2016-001515-20-IT
EUCTR2016-001515-20-ITActive, not recruitingPhase 1

EFFECT OF TERIFLUNOMIDE ON T CELL SUBPOPULATIONS INPERIPHERAL BLOOD FROM RRMS PATIENTS - nd

IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI0 sites30 target enrollmentStarted: February 7, 2018Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •Patients of male or female aged> 18 years, with relapsing remitting multiple sclerosis diagnosed according to the McDonald criteria 2010. Only patients candidates to treatment with teriflunomide will be enrolled
  • •Aged between 18-55 years
  • •EDSS between 0-5,5
  • •Patients relapse free for = 30 days prior to study entry
  • •No treatment with immunomodulatory drugs in the last 3 months
  • •Ability to provide written informed consent and be compliant with the timing of the evaluations required by the Protocol
  • •Women of childbearing potential and not complianti highly effective contraceptive measures defined in accordance with the recommendations of the Clinical Trial Facilitation Group (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf)
  • •Male patients with partners of childbearing age who do not belong to highly effective contraceptive measures defined in accordance with the recommendations of Clinical Trial Facilitation Group
  • •Women who are pregnant or breast-feeding (in all women of childbearing age before you start treatment with Teriflunomide will be made the dosage of beta-HCG in serum, and also will be made a urinary pregnancy test every month during treatment as required by the recommendations of the Clinical Trial Facilitation Group)
  • •Highly effective contraceptive measures under specific CTFG the recommendations are as follows:
  • •-patients who use combined hormonal contraceptives (containing estrogen and progesterone) associated with inhibition of ovulation or oral, intravaginal that transdermal
  • •- Patients who use hormonal contraceptives based only progesterone that inhibit ovulation, whether oral, injectable or implantable
  • •- Patients with placement of IUD (intrauterine device)
  • •-patients with positioning of hormone releasing intrauterine systems
  • •- Patients with bilateral tubal occlusion
  • •- Patients with vasectomized partner
  • •- Patients who practice sexual abstinence
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 1
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 30
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •<18 years of age; > 55 years of age.
  • •Patients diagnosed with progressive multiple sclerosis
  • •Onset of disease relapse or treatment with corticosteroids within 30 days prior to study entry
  • •Hypersensitivity to the active substance or to any of the excipients
  • •Patients with severe hepatic impairment (Child-Pugh Class C).
  • •Patients with pre-existing acute or chronic liver disease, or patients with levels of ALT (alanine aminotransferase) greater than 2 times the upper normal limit ULN).
  • •Women of childbearing potential and not compliant to highly effective contraceptive measures defined in accordance with the recommendations of the Clinical Trial Facilitation Group(http://www.hma.eu/fileadmin/dateien/Human_Medicines/01About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf). A ll women of childbearing age before starting treatment with teriflunomide it will be made the dosage of beta-HCG in serum; Also a urine pregnancy test will be performed monthly during treatment as provided by the recommendations of the Clinical Trial Facilitation Group)
  • •Women lactating
  • •Male patients with partners of childbearing age and not complianti highly effective contraceptive measures defined in accordance with the recommendations of the Clinical Trial Facilitation Group
  • •Patients with severe immunodeficiency, such as AIDS (the determination of IgG and IgM serology for HIV type 1 and 2 will be conducted prior to initiating treatment with teriflunomide)
  • •Any patients with severe active infection until resolution.
  • •Patients with latent or active tuberculosis (before starting treatment with teriflunomide will be assayed the Quantiferon test)
  • •Patients with severe renal failure requiring dialysis, there are not adequate clinical experience in this patient group.
  • •Patients with significantly impaired bone marrow function or with anemia, leucopenia, neutropenia or thrombocytopenia.
  • •Patients with severe hypoproteinaemia, eg nephrotic syndrome.
  • •Previous course of treatment with teriflunomide.
  • •Previous treatment with leflunomide (within 6 months prior to baseline).
  • •Concomitant treatment with other immunosuppressive drugs
  • •Medical or psychiatric conditions that compromise the patient's ability to give informed consent, to comply with the evaluation required under the Protocol or to complete the study.
  • •diagnosis of dementia
  • •history of malignancy, including solid tumors and hematologic malignancies
  • •History or laboratory evidence of coagulation disorders
  • •Patients with history or known presence of HBV infection, HCV (before starting treatment with teriflunomide should be performed the following serological tests: HBsAg, HBcAb confirmed by a positive research of HBV-DNA by PCR, anti HCV antibodies).
  • •Patients with history or known presence of syphilis (in the period of screening will be carried out serological tests to determine anti-VDRL antibodies)
  • •Comorbid for other neurological disorders that may mimic multiple sclerosis as neuromyelitis optica, Lyme disease, vitamin B12 deficiency is not treated, neurosarcoidosis and cerebrovascular disorders
  • •abuse of alcohol or drugs.
  • •Any contraindication to perform the Nuclear Magnetic Resonance such as: patients with cardiac pacemakers, insulin infusion pump, medication infusion device, cochlear implants, otological implants, transdermal patch of medications (nitro, hormones), which can cause problems if removed, even temporarily, any metal implants or objects piercing (s), bearers of screws, nails, bone plates, wire

Investigators

Sponsor
IVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI

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