Authorised Therapeutic use (Phase IV) Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic Axial Spondyloarthritis, Severe Chronic Plaque Psoriasis, Moderate to severe Chronic Plaque Psoriasis, Juvenile idiopathic Arthritis

An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored Secukinumab study and are judged by the investigator to benefit from continued Secukinumab treatment

EU CTIS ID: 2023-504417-67-00

What this study is testing

To evaluate long term safety as assessed by occurrence of AEs/SAEs

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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).
  • Ability to communicate effectively with the investigator, to understand and willing to comply with the requirements of the study.
  • 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).
  • 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.
  • Participant is unable to obtain access to the marketed secukinumab formulation per local prescription and/or reimbursement guidelines.

You likely can't join if

  • Participant has prematurely discontinued study treatment in the parent protocol.
  • Use of prohibited medications as listed in the Table 6-2 of the protocol
  • 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 child bearing 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.

The study team makes the final eligibility decision.

Where it's taking place

  • United States
  • Brazil
  • Colombia
  • Turkey
  • Guatemala
  • Korea, Republic of
  • Russian Federation
  • China
  • Malaysia
  • South Africa
  • India
  • Switzerland
  • Mexico

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; Brazil; Colombia; Turkey; Guatemala; Korea, Republic of and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.