A Biomarker Study of Secukinumab in RA Patients.

• Research type

  Research Study

• Full title

  A multicenter, 12 week, randomized, double-blind, placebo-controlled biomarker study of secukinumab (AIN457) in rheumatoid arthritis patients followed by an open label extension.

• IRAS ID

  79692

• Contact name

  David J A Bell

• Sponsor organisation

  Novartis Campus

• Eudract number

  2011-001220-38

• Research summary

  This is a multicenter, phase 2 biomarker study in patients with active rheumatoid arthritis (RA) with or without background DMARD therapy. The study will assess the safety and beneficial effects of the study drug in people who suffer from rheumatoid arthritis, and investigate as a primary objective whether there is an association between genetic and other biomarkers of disease and response. The study will recruit male and female patients of at least 18 years of age. Up to 500 patients may be recruited. The study consists of two parts, with a 52 weeks maximum treatment period depending on initial randomization of patients and their response to treatment, followed by a 3 month follow-up period for all patients on secukinumab.After at least 50 patients have completed the week-12 primary endpoint visit in Part 1, an interim analysis will be performed. Depending on the Interim Analysis results, the study may be terminated early. If patients show substantial benefit receiving the study drug by the end of part 1, they will proceed with part 2, an open-label extension phase. Patients with satisfactory clinical response in part 1 are eligible to continue and receive the study medication in an open label fashion. At the end of part 2 patients will be discontinued from the study medication, and all patients will enter a safety follow-up for a further 12 weeks. Patients on placebo in part 1 who complete the Week-12 visit will have the option to receive active treatment in part 2. Depending on their response 16 weeks after start of active treatment in part 2, they may be eligible to continue in the open label extension for a maximum total treatment period of 52 weeks.The planned end date for part 2 of the study is July 2012.

• REC name

  HSC REC A

• REC reference

  11/NI/0071

• Date of REC Opinion

  7 Jun 2011

• REC opinion

  Favourable Opinion