AN EXTENSION STUDY TO EVALUATE THE SUSTAINABILITY OF CLINICAL BENEFITS, SAFETY AND TOLERABILITY OF SECUKINUMAB IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS
- Conditions
- -M45M45
- Registration Number
- PER-015-14
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 34
1. Written informed consent must be obtained before any assessment is performed
2. Subjects must have completed the core study
3. Subjects who are deemed by the investigator to benefit from continued secukinumab
Therapy
1. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
2. Any subject who is deemed not to be benefiting from the study drug based upon lack of
improvement or worsening of their symptoms
3. Use of any investigational drug except for secukinumab during the core study
4. Any subject taking other concomitant biologic immunomodulating agent(s) except
secukinumab during the core study
5. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a positive
hCG laboratory test.
6. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using effective methods of contraception during
dosing of study treatment and for 16 weeks after stopping treatment. Effective
contraception methods include:
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method