A 3 yr extension study of Secukinumab in Psoriatic Arthritis patients

  • Research type

    Research Study

  • Full title

    A three-year extension study to evaluate the long term efficacy, safety and tolerability of secukinumab in patients with active psoriatic arthritis

  • IRAS ID

    135752

  • Contact name

    Arsha Clair

  • Contact email

    Arsha.Clair@novartis.com

  • Sponsor organisation

    Novartis Pharma Services AG

  • Eudract number

    2013-001241-13

  • Duration of Study in the UK

    3 years, 7 months, 1 days

  • Research summary

    Psoriatic arthritis (PsA) is a chronic inflammatory disease involving an over-active immune system that develops in 10-40% of patients with the skin condition psoriasis. The disease can cause painful inflammation in many different joints of the body including the hands, wrists, feet and larger joints as well as the lower spine and pelvis. It can also cause swelling and pain in fingers (dactylitis) and tendons (enthesitis). It has a strong genetic link.

    Treatment of the disease aims to reduce pain and inflammation. Recently biologic drugs have proven successful at treating PsA. Biologics are protein based drugs which can target particular elements of the over-active immune system. The most commonly used biologic treatments for PsA are drugs which block a particular chemical messenger called TNF-alpha.

    Secukinumab is a new class of biologic which blocks the activity of one of the chemical messages which is involved in the immune system and is implicated in psoriatic arthritis. This study aims allow patients already participating in a clinical study (CAIN457F2306, "core study") to continue to receive treatment for another three years.

    All patients completing the core study will be eligible for this extension study.

  • REC name

    West Midlands - Edgbaston Research Ethics Committee

  • REC reference

    13/WM/0365

  • Date of REC Opinion

    2 Oct 2013

  • REC opinion

    Favourable Opinion