Clinical study comparing the new immunosuppresive drug gusperimus with the conventional treatment in Wegener?s Granulomatosis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 216

Inclusion Criteria

1.Documented diagnosis of WG according to the ACR classification criteria.
2.Diagnosis of WG at least 6 months before entry and initial induction therapy with a combination of GC and an immunosuppressive (CYC or MTX) or rituximab.
3.Relapse of WG with or without ongoing GC, and/or immunosuppressive therapy with AZA/MMF/MTX or LEF. The minimum disease activity is defined by the presence of one new/worse major or three new/worse minor BVAS (version 3) items.
4.Patients between 18 ? 75 years.
5.Medically acceptable and reliable contraception method during the study course. (Women should not become pregnant for at least 6 months after CYC treatment).
6.Written informed consent for study participation given by the patient.
7.Patients able and prepared to self-administer the study medication or having a relative/third person able to do it.
8.Ability to read, understand and record information required by protocol.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

1.Other multi-system autoimmune disorders, including systemic lupus erythematosus and anti-GBM disease.
2.Systemic vasculitis due to a viral infection.
3.CYC therapy intolerance, hypersensitivity or contraindication to CYC (active substance or any of the excipients) in patients with severe relapse of WG.
4.Hypersensitivity or contraindication to
-Spanidin (active substance or any of the excipients) or
-both MTX (active substance or any of the excipients) and AZA (active substance or any of the excipients) or
-methylprednisolone, prednisolone or other corticosteroids (active substance or any of the excipients).
5.Underlying medical conditions, which in the opinion of the Investigator place the patient at an unacceptable risk level for participating in a study.
6.Previous randomisation in this study.
7.CYC, intravenous immunoglobulin, anti-cytokine biologic therapies, plasma exchange or Abatacept in the three months prior to entry to the trial. Rituximab, Alemtuzumab or stem cell transplantation is not permitted in the six months prior to entry to the trial.
8.Previous treatment with gusperimus.
9.Participation in another clinical trial with investigational drugs within the last 3 months before screening or during the present trial period.
10.Pregnant or breast-feeding females.
11.Active bacterial/viral infection (HIV, Hepatitis B, Hepatitis C, Tuberculosis).
12.Patients with eGFR < 15 mL/min/1.73m2 (MDRD equation).
13.ALT, AST, bilirubin, and ALP levels above 2 x the upper normal limit.
14.Inadequate bone-marrow function: WBC < 4000/mm3, haemoglobin < 8 g/dL, neutrophils < 2500/mm3, platelets < 100 000/mm3.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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