Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener’s Granulomatosis

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Brief Title

Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis

Official Title

Randomised, Evaluator-Blinded, Multicentre, International, Parallel-Group, Active-Controlled Clinical Trial of Gusperimus Versus Conventional Therapy in Relapse of Granulomatosis With Polyangiitis (Wegener's Granulomatosis) SPARROW Study - SPAnidin in Relapsing GRanulomatosis With POlyangiitis Wegener's Granulomatosis)

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 steroids, and/or immunosuppressive therapy. Further, to evaluate the safety
      and quality of life of gusperimus treatment compared to standard treatment in patients with
      relapse of Wegener Granulomatosis receiving glucocorticoids.
    

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 relapse is frequent and requires increased exposure to these toxic drugs. In
      other patients initiation or continuation of these standard drugs is contraindicated due to
      intolerable side effects. No well-established therapy is available for relapsing patients.
      They may suffer severe organ damage due to progressive disease, or may die. The proposed
      indication for gusperimus is the treatment of relapsing Wegener Granulomatosis. The aim of
      therapy with gusperimus is to induce and maintain remission thereby avoiding further
      cyclophosphamide and reducing corticosteroid exposure.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Response rate

Secondary Outcome

 Time to response

Condition

Wegeners Granulomatosis

Intervention

Gusperimus + glucocorticoids

Study Arms / Comparison Groups

 Test group - gusperimus
Description:  Both severity subgroups (severe and non-severe) will be treated with gusperimus + glucocorticoids.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

4

Start Date

November 2011

Completion Date

January 2015

Primary Completion Date

November 2012

Eligibility Criteria

        Inclusion Criteria:

          1. Documented diagnosis of Wegener's Granulomatosis (WG) according to the American
             College of Rheumatology classification criteria.

          2. 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.

          3. 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.

          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 Cyclophosphamide 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

        Exclusion Criteria:

          1. Other multi-system autoimmune disorders, including systemic lupus erythematosus and
             anti-Glomerular Basement Membrane disease.

          2. Systemic vasculitis due to a viral infection.

          3. Cyclophosphamide therapy intolerance, hypersensitivity or contraindication to
             Cyclophosphamide (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 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).

          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. 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.

          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 (Human Immunodeficiency Virus, Hepatitis B, Hepatitis
             C, Tuberculosis).

         12. Patients with Glomerular Filtration Rate (eGFR) < 15 mL/min/1.73m2.

         13. Alanine transaminase (ALT), Aspartate aminotransferase (AST), bilirubin, and Alkaline
             phosphatase (ALP) levels above 2 x the upper normal limit.

         14. Inadequate bone-marrow function: White Blood Cells (WBC) < 4000/mm3, haemoglobin < 8
             g/dL, neutrophils < 2500/mm3, platelets < 100 000/mm3.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

David Jayne, MD, , 

Location Countries

Czech Republic

Location Countries

Czech Republic

Administrative Informations


NCT ID

NCT01446211

Organization ID

NO005-NK103

Secondary IDs

2011-001219-30

Responsible Party

Sponsor

Study Sponsor

Nordic Pharma SAS


Study Sponsor

David Jayne, MD, Principal Investigator, Addenbrookes Hospital, Cambridge, United Kingdom


Verification Date

January 2015