A Prospective, obServational pOst maRketing survEillance study to evAluate the effectiveness and safety of secukinumab in Indian patients with moderate to severe pLaque psoriasis (PSO-REAL Study)
Phase 4
Completed
- Conditions
- Health Condition 1: null- psoriasis
- Registration Number
- CTRI/2016/12/007566
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
1.Moderate to severe Plaque Psoriasis patients prescribed with secukinumab as per approved package insert and who are not treated with secukinumab 6 months prior to entering the study.
2.Patients willing to participate in the study by providing written informed consent.
Exclusion Criteria
1.Contraindication as per PI
2.Patients simultaneously participating in other studies
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of secukinumab in subjects with moderate to severe Plaque Psoriasis at Week 12 with respect to PASI (Psoriasis Area Severity Index) 75 response rate from baseline.Timepoint: study duration up to Month 24
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of secukinumab in subjects with moderate to severe Plaque Psoriasis at Week 16 with respect to PASI (Psoriasis Area Severity Index) 50, PASI 75, PASI 90 and PASI 100 response rates from baseline. <br/ ><br>To evaluate the efficacy of secukinumab in subjects with moderate to severe Plaque Psoriasis at Week 12 with respect to PASI (Psoriasis Area Severity Index) 50, PASI 90 and PASI 100 response rates from baseline. <br/ ><br>Timepoint: study duration up to Month 17