Psoriatic Arthritis, Ankylosing Spondylitis, non-radiographic axial spondyloarthritis, Severe Chronic Plaque Psoriasis, moderate to severe chronic plaque psoriasis MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Cosentyx
Product Name: Secukinumab
Product Code: AIN457
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: secukinumab
CAS Number: 1229022-83-6
Current
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent must be obtained for adult participants before any assessment is performed. Written informed assent and parental permission (age as per local law) must be obtained for pediatric participants before any assessment is performed. If participants reach age of consent (age as per local law) during the study, they will need to also sign the corresponding study informed consent(s). 2. Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study. 3. Participant has completed treatment per protocol in a Novartis Study of Secukinumab (unless otherwise specified in a parent study protocol). Participants, who derive benefit from the treatment with secukinumab but have not completed the treatment in certain parent studies, due to parent study termination by Novartis, may be eligible if the termination was due to reasons other than safety or lack of efficacy (technical / administrative reasons). 4. Participant is deriving benefit from secukinumab, investigator believes he/she would continue to derive benefit from secukinumab and the benefit outweighs the risk, based on the investigator’s judgement. 5. Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/ or reimbursement guidelines. Are the trial subjects under 18? yes Number of subjects for this age range: 49 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 453 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 274
Exclusion criteria
Exclusion criteria: 1. Participant has prematurely discontinued study treatment in the parent protocol. 2. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of contraception during the entire study or longer if required by locally approved prescribing information (e.g., in European Union (EU) 20 weeks). Contraception methods include: · Total abstinence, when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. · Female sterilization (have had surgical bilateral oophorectomy [with or without hysterectomy], total hysterectomy or bilateral tubal ligation at least six weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. · Male sterilization (at least 6 months before taking study treatment). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. · Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For United Kingdom: with spermicidal foam/gel/film/cream/vaginal suppository. · Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS). In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. In case local regulations deviate from the contraception methods listed above, local regulations apply and will be described in the informed consent form (ICF).Note: Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). Women are considered not of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks prior to enrollment. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of childbearing potential. 3.Use of prohibited medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate long term safety as assessed by occurrence of AEs/SAEs;Secondary Objective: Not applicable;Primary end point(s): Serious adverse events (SAEs), adverse events (AEs), and injection site reactions;Timepoint(s) of evaluation of this end point: Over time up to EOS or Week116 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Brazil, Bulgaria, China, Colombia, Czech Republic, Greece, Guatemala, India, Korea, Republic of, Malaysia, Mexico, Poland, Russian Federation, South Africa, Turkey, United States
Contacts
Public ContactInformacní služba – klin. hodnocení
Novartis s.r.o.
Outcome results
None listed