Alemtuzumab for ANCA Associated Refractory Vasculitis

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Brief Title

Alemtuzumab for ANCA Associated Refractory Vasculitis

Official Title

Alemtuzumab for ANCA Associated Refractory Vasculitis - a Study of Safety and Efficacy

Brief Summary

      Overview:

      This open label, randomized, multi-centre study will enroll and treat 24 patients with
      refractory AAV.

      Aims:

      To determine the clinical response and severe adverse event rates associated with alemtuzumab
      therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV).

      Hypothesis:

      Treatment with alemtuzumab induces sustained remission in AAV and will reduce
      immunosuppressive and steroid exposure.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Proportion of patients with a vasculitis response at 6 months

Secondary Outcome

 Proportion of patients with treatment failure

Condition

Vasculitis

Intervention

Alemtuzumab

Study Arms / Comparison Groups

 Alemtuzumab - high dose (60mg)
Description:  Alemtuzumab 30mg will be administered on Day 1 and Day 2 at 0 and 6 months

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

24

Start Date

February 2011

Completion Date

March 2014

Primary Completion Date

March 2014

Eligibility Criteria

        Inclusion Criteria:

          1. A diagnosis of AAV, according to a standardized definition

          2. Active vasculitis with at least one severe or three non severe items of BVAS/WG
             activity (equivalent to BVAS/WG>3)

          3. Previous therapy with either cyclophosphamide or methotrexate, in combination with
             prednisolone for at least 3 months.

        Exclusion Criteria:

          1. Age less than 18 or greater than 60 years

          2. Creatinine > 150μmol/l (1.7mg/dl)

          3. Total white count < 4x109/l or lymphocyte count < 0.5x109/l, or IgG < 5g/L, or
             neutrophil count < 1.5x109/l.

          4. Severe lung haemorrhage with hypoxia (<85% on room air)

          5. Severe gastrointestinal, central nervous system or cardiac vasculitis

          6. Previous therapy with:

               1. Alemtuzumab at any time

               2. IVIg, infliximab, etanercept, adalimumab, abatacept, anti-thymocyte globulin or
                  plasma exchange in past three months

               3. Rituximab within the past 6 months

          7. Intensive care unit requirement

          8. Active infection with HIV, hepatitis B or hepatitis C or other infection requiring
             parenteral or long-term oral antibiotics

          9. History of ITP or platelet count at screening below 50,000 x 106/l

         10. Pregnancy or inadequate contraception in pre-menopausal women

         11. Breast feeding

         12. Any condition judged by the investigator that would cause the study to be detrimental
             to the patient.

         13. Any other multisystem autoimmune disease including Churg Strauss angiitis, systemic
             lupus erythematosus, anti-GBM disease and cryoglobulinaemia

         14. Any previous or current history of malignancy (other than resected basal cell
             carcinoma)
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

David RW Jayne, MD MRCP, 00441223586796, [email protected]

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT01405807

Organization ID

AL1.1

Secondary IDs

2009-017087-17


Study Sponsor

Cambridge University Hospitals NHS Foundation Trust


Study Sponsor

David RW Jayne, MD MRCP, Principal Investigator, Cambridge University Hospitals NHS Foundation Trust


Verification Date

July 2011