Abatacept in ANCA Associated Vasculitis

NCT00482066 | Terminated Phase 2 DMC

• 3 other identifiers: cro6322006-001859-35BMS protocol No: IST110
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether abatacept can prevent relapse in patients with ANCA associated vasculitis(AAV). This is a randomised double blinded placebo controlled trial.

Conditions

ANCA-associated Vasculitis

Keywords

Wegener's granulomatosis; Microscopic polyangiitis; Churg Strauss Syndrome; ANCA

Outcome Measures

Primary Outcomes (1)

• Relapse rate over 24 months.

  2 years

Secondary Outcomes (8)

• Proportion of patients in sustained remission (i.e. remission at 3 months sustained for 6 months and remission at 6 months sustained for a further 12 months);

  2 years

• Time to remission;

  2 years

• The average steroid dosage at 6 months, 1 year, 18 months and 2 years in abatacept and placebo groups respectively;

  2 years

• Time to ANCA negativity by immunofluorescence or negative anti-PR3 or anti-MPO Ab test by ELISA.

  2 years

• Proportion of patients defaulting to cyclophosphamide (MMF, azathioprine or other rescue) therapy.

  2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Abatacept (Orencia)

Drug: Abatacept (Orencia)

2

PLACEBO COMPARATOR

saline placebo

Drug: Abatacept (Orencia)

Interventions

Abatacept (Orencia) DRUG

500mg for patients under 60kg 750mg for patients 60-100kg 1g for patients\>100kg given as i.v. infusion over 30 minutes at day 0, 14, 28 and then monthly for a further 11 months 914 infusions in total) placebo groups receive saline only I.v.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute AAV, presenting at first diagnosis or relapse, defined by clinical presentation
• ANCA positivity (anti-MPO or anti-PR3 positive)
• BVAS score of \> 8.

You may not qualify if:

• Severe life-threatening disease, i.e. lung haemorrhage at the time of presentation, renal impairment with SCr\>150 micromol/l, or severe CNS dysfunction thought to be due to vasculitis.
• Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease, or other medical conditions that might place the subject at unacceptable risk for participation in this study.
• Any other non-vasculitic multisystem autoimmune disease
• Serious acute or bacterial infection unless treated and completely resolved with antibiotics prior to enrolment
• With any severe chronic or recurrent bacterial infection
• With Hepatitis B or C or HIV
• With Herpes zoster infection that resolved less than 2 months prior to enrolment
• Subjects who have received any live vaccines within 3 months of the first dose of study medication or who will have need of a live vaccine at any time in the year following enrolment
• Subjects with current clinical or laboratory evidence of active or latent tuberculosis (TB) and subjects with a history of active TB treated within the last 3 years
• With any previous malignancy, with the exception of non-melanoma skin malignancies, adequately treated previously
• Subjects with a mammogram that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional evaluations. Mammograms (females only) must be performed within 6 months of study entry or if documentation is not on file.
• With MTX treatment in prior 3 months
• Subjects with prior therapy with rituximab, anti-TNF therapy, or IL-1 receptor antagonists within last year or cyclophosphamide within last six months
• Subjects with a history of intolerance to methotrexate
• Subjects who have at any time received treatment with abatacept

Sponsors & Collaborators

• Imperial College London: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Imperial College London, Hammersmith Hospital

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Granulomatosis with Polyangiitis; Microscopic Polyangiitis; Churg-Strauss Syndrome

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Alan Salama

  Imperial College London

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2007
• First Posted: June 4, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 29, 2015

Record last verified: 2015-03

Locations

GB (1)