Prevention of re-onset of HBV infection in patients apparently cured affected by rheumatological diseases requiring finite duration treatments with drugs that impair the immune systems.

Phase 1

Active, not recruiting

Conditions: Occult Hepatitis B virus Infection (OBI) in patients with rheumatologic diseases candidate to treatment a finite duration (less than 18 months) with potent immune suppressive drugs
MedDRA version: 20.0Level: HLTClassification code 10037163Term: Psoriatic arthropathiesSystem Organ Class: 100000004859
MedDRA version: 20.1Level: HLTClassification code 10057212Term: Hepatitis viral infectionsSystem Organ Class: 100000004862
MedDRA version: 20.0Level: HLTClassification code 10039075Term: Rheumatoid arthritis and associated conditionsSystem Organ Class: 100000004870
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2015-000570-35-IT

Lead Sponsor: DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA - UNIVERSITÀ DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

- Age > 18 years;
- Patient affected by rheumatois arthrits and psoriasic arthrits, non responders to DMARDs (AR) or FANS/DMARDs (AP), candidates to immunesuppressive treatment with etanercept or adalimubab (finite therapy of 18 months)
- Written informed consent
- HBsAg negativity, anti-HBc positivity (with/without anti-HBs)
- HBV-DNA negativity (by Polymerase Chain Reaction)
- Normal liver tests (AST ed ALT <1,5 i valori max normali; PCHE, serum Albumin and Total Bilirubin levels within normal range)
- anti-HIV negativity
- anti-HCV negativity
- no Latent Tubercolosis infection (through IGRA test and skin test)
- Absence of controindications to Tenofovir
- Normal kidney function (ClCr > 80 ml/min, serum phospate > 2 mg/dl)
- No previous treatment with HBV drugs
- Adoption of adequate contraceptive measures in childbearing wowen
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

- Age < 18 years;
- Patient not affected by rheumatois arthrits and psoriasic arthrits and not candidate to immunesuppressive treatment including
etanercept or adalimubab (finite therapy of 18 months)
- No written informed consent
- Previous succesfull HBV vaccination
- HBsAg positivity
- Anti-HBc negativity
- Abnormal liver tests (AST ed ALT >1,5 max normal values; PCHE, serum Albumin and Total Bilirubin levels outside normal range)
- anti-HIV positivity
- anti-HCV positivity
- Latent Tubercolosis infection
- Controindications to Tenofovir
- Abnormal kidney function ( creatinine clearance < 80 ml/min, serum phosphate < 2 mg/dl)
- Previous treatment with HBV drugs
- Refusal of adoption of adequate contraceptive measures in childbearing wowen
- Pregnancy
- Breastfeeding