An observational study in Moderate-to-severe Plaque Psoriasis, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Novartis Pharmaceuticals · Observational
This study was a one-arm, retrospective cohort study that observed clinical psoriasis patients who received secukinumab treatment in Indonesia from the 01 August 2017 until the 31 October 2020. Patients' data were obtained from the medical records of a dermatology clinic in Jakarta, Indonesia. The primary endpoints were set at Week 16, and secondary endpoints at Weeks 16 and 52. At each endpoint, the study assessed effectiveness by measuring the proportion of psoriasis patients receiving secukinumab who achieved Psoriasis Area and Severity Index (PASI) 75 (at Week 8) and PASI 90 (at Weeks 16 and 52).
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 79 is below the median of 200 across 396 observational studies indexed under Psoriasis.
Browse Psoriasis studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
This was a retrospective, noninterventional cohort study
Exclusion Criteria
Clinical psoriasis patients who received secukinumab treatment in Indonesia from 1 August 2017 to 31 October 2020.
Percentage of patients achieving Psoriasis Area and Severity Index (PASI) score <1, PASI score < 2, PASI score < 3, and PASI score < 5 at Week 16
The PASI is used for assessing and grading the severity of psoriatic lesions and their response to therapy. PASI scores can range from a lower value of 0, corresponding to no signs of psoriasis, up to a theoretic maximum of 72.0.
Time frame: Week 16
Percentage of patients achieving PASI 75 or higher response at Week 8
PASI 75 response was defined as ≥ 75% improvement (reduction) in PASI score compared to baseline.
Time frame: Week 8
Percentage of patients achieving PASI 90 or higher response at Week 16
PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Time frame: Week 16
Percentage of patients achieving PASI 90 or higher response at Week 52
PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Time frame: Week 52
Number of injections needed to achieve at least PASI 90
PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Time frame: Weeks 16 and 52
Percentage of patients with psoriatic arthritis (PsA) who achieved at least PASI 90 at Week 16 with secukinumab
PASI 90 response was defined as ≥ 90% improvement (reduction) in PASI score compared to baseline.
Time frame: Week 16
Percentage of patients with relapse event after treatment discontinuation
Time frame: Up to 52 weeks
Length of remission period for patients with relapse, calculated from the last treatment date until relapse or starting recurrent symptom(s) or sign(s)
Time frame: Up to 52 weeks
Percentage of patients achieving Dermatology Life Quality Index (DLQI) 0/1 at Week 52
DLQI is a ten-item general dermatology disability index designed to assess healthrelated quality of life in adult participants with skin diseases such psoriasis. It is a selfadministered questionnaire which includes domains of daily activity, leisure, personal relationships, symptoms and feelings, treatment and school/work activities. Each domain has 4 response categories ranging from 0 (not at all) 1 ( a little) to 3 (very much). "Not relevant" is a valid score also and is scored as 0.
Time frame: Week 52
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novartis Pharmaceuticals