Patients with ANCA-associated Vasculitis MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis
Conditions
Interventions
Trade Name: ORENCIA
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: ABATACEPT
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical for
Sponsors
AZIENDA OSPEDALIERA DI PARMA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Males and females (not nursing and not pregnant) at least 18 years of age. Women of child bearing potential are eligible if they are practicing effective contraceptive measures With Acute AAV, presenting at first diagnosis or relapse (not grumblers, to maximize effect seen), defined by clinical presentation with Wegener?s Granulomatosis (WG), microscopic polyangiitis (MPA) or Churg-Strauss syndrome (CSS)* and ANCA positivity (anti-MPO or anti-PR3 positive) or historical ANCA positivity, and a BVAS score of > 8. Written informed consent given Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Those with severe life-threatening disease, i.e. lung haemorrhage at the time of presentation, renal impairment with SCr>150 mcmol/l, or severe CNS dysfunction thought to be due to vasculitis. Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease, or other medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. With any other non-vasculitic multisystem autoimmune disease. With any serious acute bacterial infection unless treated and completely resolved with antibiotics prior to enrollment With any severe chronic or recurrent bacterial infection, e g. bronchiectasis, osteomyelitis, chronic pyelonephritis With Hepatitis B or C or HIV. With Herpes zoster infection that resolved less than 2 months prior to enrollment. 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 enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Response to treatment will be measured by the relapse rates in patients who have achieved remission over 24 month study period.;Secondary Objective: Response to treatment will also be measured by: The proportion of patients in sustained remission at 6, 12, 18 months and 24 months; The time to remission; The average steroid dosage at 6, 12,18 and 24 months; The time to ANCA negativity by immunofluorescence or negative anti-PR3 or anti-MPO Ab test by ELISA; Urinary MCP-1 measurement to assess disease activity.;Primary end point(s): Response to treatment will be measured by the relapse rates in patients who have achieved remission over 24 month study period. | — |
Countries
Italy
Outcome results
None listed