An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis

Phase 2

Conditions: Ankylosing spondylitis
Bechterew's disease
10003816

Registration Number: NL-OMON36799

Lead Sponsor: ovartis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

1. Patients who participate and complete the core CAIN457A2209 study up to and including
the EoS i.e. Visit 16 (Week 24), may enter the extension study upon signing informed
consent.
2. Patients who discontinued the core study due to unsatisfactory therapeutic effect at their
Visit 14 (Week 16) or later may enter the extension study within three weeks of
completing the study discontinuation visit of the core study, provided that at their
discontinuation visit they meet the criteria below. Patients who do not enter the extension
study within 3 weeks of completing the study discontinuation visit of the core study, will
have an additional baseline visit (Visit 17) and must meet the criteria below:
a. There is no improvement (compared with the core study baseline) in two out of the
following four domains: patient global assessment, pain, BASFI and the mean of the
two morning stiffness questions from the BASDAI
OR
a. There is a deterioration (compared with the core study baseline) in one of the four
domains (deterioration defined as ><=20% worsening and an absolute worsening of
><=1 unit)
3. Women of childbearing potential must be using simultaneously double-barrier or two
highly effective methods of contraception, (e.g. intra-uterine device plus condom,diaphragm plus condom, etc; hormone replacement as either oral or implantable is acceptable as one form), from the time of screening for the duration of the entire study, up to study completion and up to 16 weeks post last drug administration. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
4. Male patients willing to use simultaneously two highly effective methods of contraception
(e.g. intra-uterine device plus condom) for the duration of the entire study, up to study
completion visit and up to 16 weeks post the last drug administration. Periodic abstinence
and withdrawal are not acceptable methods of contraception.

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from entry into the study:
1. Patients for whom continued treatment with AIN457 in the extension is not considered
appropriate by the treating physician.
2. Patients who were non-compliant or who demonstrated a major protocol deviation in the
core CAIN457A2209 study.
3. Patients who discontinued from the core CAIN457A2209 study before Visit 14
(Week 16).
4. Female patients who are pregnant or lactating
5. Any active systemic infection within the past 2 weeks including a positive chest X-ray.
6. Positive human immunodeficient virus (HIV: ELISA and Western blot) test result,
Hepatitis B surface antigen (HBsAg) or Hepatitis C test result, where patients have been
re-tested.
The following Exclusion Criteria as defined in the core trial [CAIN457A2209] will continue
to be valid with minor revisions:
7. Positive Purified Protein Derivative (PPD) tuberculin skin test of * 5 mm at baseline,
(where patients have been re-tested). A positive PPD test will be defined using the
MMWR 2000 guidance, summarized as criteria for tuberculin positivity by risk group.
A PPD test should not be done in subjects who had a tuberculosis vaccination in the past.
These subjects will be eligible to participate if * according to local guidelines * latent
tuberculosis can be excluded. For those study sites using QuantiFeron test a positive test at
baseline (where patients have been re-tested) will exclude the subject from the
participation in the study. If the result for either PPD or QuantiFeron test is indeterminate
the subject will be excluded.
8. For previous use of immunosuppressive agents a wash-out period of at least 1 month or
5 half-lives, whatever is longer, is required. Immunosuppressive agent include but are not
limited to cyclosporine, mycophenolate, tacrolimus, and 5-aminosalicylic acid (5-ASA).
If on previous treatment with anti-TNF-* therapy (or other biological therapy), the
following washout periods will be required for such patients to be eligible to participate
in the trial.* Six (6)-months wash out prior to dosing for alefacept, rituxan and raptiva,
* Three (3)-months washout prior to baseline for adalimumab and certolizumab,
* Two (2)-months washout prior to baseline for etanercept and infliximab,
* One (1) month washout prior to baseline for systemic immunosuppressants including,
but not limited to azathioprine, cyclosporine, and leflunomide.
Patients on concomitant prednisone, methotrexate (MTX) or SSZ can be included,
whereby:
* Prednisone should be kept at a stable dose 4 weeks before baseline and throughout the
study and not exceed 10 mg/day.
* MTX should be kept at a stable dose 4 weeks before baseline and throughout the
study and not exceed 25 mg/week.
* SSZ should be kept at a stable dose 4 weeks before baseline and throughout the study.
9. Patients who are on NSAIDS should be kept at a stable dose 4 weeks before baseline and
throughout the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the safety and tolerability of AIN457 in patients with moderate to<br /><br>severe ankylosing spondylitis receiving i.v. AIN457 initially up to 6 months<br /><br>(Part 1) with a possible extension of a further 6 months (Part 2) in patients,<br /><br>who participated in the core CAIN457A2209 phase II proof-of-concept study</p><br>

Secondary Outcome Measures

Name	Time	Method

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