Phase II Study on Gusperimus in Patients With Refractory Wegener’s Granulomatosis

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Brief Title

Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis

Official Title

Phase II Study on Gusperimus in Patients With Refractory Wegener's Granulomatosis

Brief Summary

      Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and
      necrotizing inflammation predominantly affecting the respiratory tract and the kidneys.
      Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is
      limited by incomplete remissions and a high relapse rate. Patients accumulate irreversible
      damage due to the disease and the consequences of prolonged drug exposure. The efficacy and
      safety of an alternative immunosuppressive drug, gusperimus, was evaluated in patients with
      refractory disease. A prospective, international, nulti-centre, single limb, open label
      study. Entry required active Wegener's granulomatosis with a Birmingham Vasculitis Activity
      Score (BVAS) >=4 and previous therapy with cyclophosphamide or methotrexate.
      Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to
      clinical status. Gusperimus, 0.5mg/kg/day, was self-administered by subcutaneous injection in
      six treatment cycles of 21 days with a seven day washout between cycles. Cycles were stopped
      early for white blood count < 4,000/mm3. The primary endpoint was complete remission (BVAS=0
      for at least 2 months) or partial remission (BVAS<50% of entry score). After the sixth cycle
      azathioprine was commenced and follow-up continued for a further six months.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Remission of Vasculitis

Secondary Outcome

 Duration of Clinical Response

Condition

Wegener's Granulomatosis

Intervention

Gusperimus

Study Arms / Comparison Groups

 1
Description:  Gusperimus

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

45

Start Date

December 2003

Completion Date

February 2006

Primary Completion Date

February 2006

Eligibility Criteria

        Inclusion Criteria:

          -  Documented diagnosis of WG according to American College of Rheumatology (ACR) and
             Chapel Hill Consensus Conference (CHCC) definition

          -  BVAS >= 4

          -  Total disease duration >= 3 months treated with CYC or >= 6 months with MTX

          -  Age 18 - 80

          -  WBC >= 4,000/mm3, haemoglobin >= 8g/dl, neutrophils >= 2,500/mm3, platelets >=
             100,000/mm3

          -  ALT, bilirubin and alkaline phosphatase levels within 2x the upper limits of normal

          -  Documented to be non-pregnant by serum/urine pregnancy test

          -  Willing to participate in this study

          -  Provide signed informed consent

          -  Able and prepared to self-administer the study drug or have a close friend/relative
             able to do this

        Exclusion Criteria:

          -  Participation in another clinical research study

          -  Pregnant or nursing mothers and women of childbearing age not using appropriate
             contraception

          -  Clear evidence of active disease due to bacteria/viral infection

          -  Patient has an unacceptable risk for participation in a study of immunosuppressive
             therapy

          -  History of substance abuse or psychotic disorders

          -  Previous treatment with Gusperimus
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

David Jayne, , 

Location Countries

Czech Republic

Location Countries

Czech Republic

Administrative Informations


NCT ID

NCT00530075

Organization ID

102



Study Sponsor

Nippon Kayaku Co., Ltd.


Study Sponsor

David Jayne, Principal Investigator, Addenbrookes Hospital


Verification Date

September 2007