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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-02-28

Brief Summary

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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 Immunosuppressive drugs were withdrawn at entry and prednisolone doses adjusted according to clinical status.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.

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Detailed Description

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Conditions

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Wegener's Granulomatosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Gusperimus

Group Type EXPERIMENTAL

Gusperimus

Intervention Type DRUG

SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles

Interventions

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Gusperimus

SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No