Abatacept in ANCA associated vasculitis: ABAVAS - ABAVAS

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Patients with Acute AAV, presenting at first diagnosis or relapse (not grumblers, to maximize effect seen), defined by clinical presentation, ANCA positivity (anti-MPO or anti-PR3 positive) and a BVAS score of > 8.

2. 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

3. 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

1. Subjects 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

2. 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.

3. Subjects with any other non-vasculitic multisystem autoimmune disease.

4. Subjects with any serious acute bacterial infection unless treated and completely resolved with antibiotics prior to enrollment

5. Subjects with any severe chronic or recurrent bacterial infection, e g. bronchiectasis, osteomyelitis, chronic pyelonephritis

6. Subjects with Hepatitis B or C or HIV.

7. Subjects with Herpes zoster infection that resolved less than 2 months prior to enrollment.

8. 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

9. 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 should be excluded.
Subjects who received treatment for active TB greater than 3 years ago may be eligible for inclusion in this study if there is documentation of the prior anti-TB treatment confirming that it was appropriate in duration and type.

10. Subjects with any previous malignancy, with the exception of non-melanoma skin malignancies, adequately treated previously

11. Subjects with a mammogram that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional
clinical, laboratory or other diagnostic evaluations. Mammograms (females only)
must be performed within 6 months of study entry or if documentation is not on file

12. Pregnancy or breast feeding. Adequate contraception is necessary;
13. Subjects with MTX treatment in prior 3 months

14. Subjects with allergies to study medications.

15. Prior therapy with rituximab within the last 6 months (CD19 count must be normal before enrollment regardless of time of last dose). ; anti-TNF therapy, or IL-1 receptor antagonists within the last 3 months.

16. Subjects participating concurrently in another clinical trial.

17. Subjects with a history of intolerance to methotrexate.

18. Subjects who have at any time received treatment with abatacept.

19. Subjects who have received treatment with any investigational drug within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1 dose.

20. Subjects with any of the following laboratory values:
- Hgb < 8.5 g/dL.
-WBC < 3,000/mm3 (3 x 109/L)
-Platelets < 100,000/mm3 (100 x 109/L).
-Serum ALT or AST > 2 times upper limit of normal.
-Any ot

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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