Status:
TERMINATED
Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis
Lead Sponsor:
Nordic Pharma SAS
Conditions:
Wegeners Granulomatosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared to conventional treatment in patients with a relapse of Wegener Granulomatosis with or without ongoing stero...
Detailed Description
Wegener Granulomatosis without treatment is life-threatening. The standard treatment with corticosteroids and cyclophosphamide is usually effective at controlling active disease. However, disease rela...
Eligibility Criteria
Inclusion
- Documented diagnosis of Wegener's Granulomatosis (WG) according to the American College of Rheumatology classification criteria.
- Diagnosis of WG at least 6 months before entry and initial induction therapy with a combination of Glucocorticoids and an immunosuppressive (Cyclophosphamide or Methotrexate) or rituximab.
- Relapse of WG with or without ongoing Glucocorticoids, and/or immunosuppressive therapy with Azathioprine/Mycophenolate Mofetil/Methotrexate or Leflunomide. The minimum disease activity is defined by the presence of one new/worse major or three new/worse minor BVAS (version 3) items.
- Patients between 18 - 75 years.
- Medically acceptable and reliable contraception method during the study course. (Women should not become pregnant for at least 6 months after Cyclophosphamide treatment).
- Written informed consent for study participation given by the patient.
- Patients able and prepared to self-administer the study medication or having a relative/third person able to do it.
- Ability to read, understand and record information required by protocol
Exclusion
- Other multi-system autoimmune disorders, including systemic lupus erythematosus and anti-Glomerular Basement Membrane disease.
- Systemic vasculitis due to a viral infection.
- Cyclophosphamide therapy intolerance, hypersensitivity or contraindication to Cyclophosphamide (active substance or any of the excipients) in patients with severe relapse of WG.
- Hypersensitivity or contraindication to
- Spanidin (active substance or any of the excipients) or
- both Methotrexate (active substance or any of the excipients) and Azathioprine(active substance or any of the excipients) or
- methylprednisolone, prednisolone or other corticosteroids (active substance or any of the excipients).
- Underlying medical conditions, which in the opinion of the Investigator place the patient at an unacceptable risk level for participating in a study.
- Previous randomisation in this study.
- Cyclophosphamide , 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.
- Previous treatment with gusperimus.
- Participation in another clinical trial with investigational drugs within the last 3 months before screening or during the present trial period.
- Pregnant or breast-feeding females.
- Active bacterial/viral infection (Human Immunodeficiency Virus, Hepatitis B, Hepatitis C, Tuberculosis).
- Patients with Glomerular Filtration Rate (eGFR) \< 15 mL/min/1.73m2.
- Alanine transaminase (ALT), Aspartate aminotransferase (AST), bilirubin, and Alkaline phosphatase (ALP) levels above 2 x the upper normal limit.
- Inadequate bone-marrow function: White Blood Cells (WBC) \< 4000/mm3, haemoglobin \< 8 g/dL, neutrophils \< 2500/mm3, platelets \< 100 000/mm3.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01446211
Start Date
November 1 2011
End Date
January 1 2015
Last Update
May 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Všeobecná fakultní nemocnice v Praze
Prague, Czechia, 128 08