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)

A Prospective, obServational pOst maRketing survEillance study to evAluate the effectiveness and safety of secukinumab in Indian patients with moderate to severe pLaque psoriasis requiring systemic therapy (PSO-REAL Study) - PSO-REAL study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/12/007566

Enrollment

Registered

2016-12-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- psoriasis

Interventions

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Contraindication as per PI 2. Patients simultaneously participating in other studies

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. 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. Timepoint: study duration up to Month 17	—

Measure

Time frame

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. 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. Timepoint: study duration up to Month 17

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Countries

India

Contacts

Public ContactDr Venkatramana Nagire

Medical Advisor- Dermatology

venkatramana.nagire@novartis.com24958562

Outcome results