Extension study up to three years for secukinumab in psoriatic arthritis

Phase 1

• Conditions: Psoriatic arthritis; MedDRA version: 14.1Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-001241-13-IT
• Lead Sponsor: ovartis Farma SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-12
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

- Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
- Subjects must have participated in core study CAIN457F2306, and must have completed the entire treatment period
- Subjects must be deemed by the investigator to benefit from continued secukinumab therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 468
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 47

Exclusion Criteria

- Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
- Any subject who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment

Other protocol-definied exclusion criteria may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified