20090402: Phase 2, Long Term Assessment, AMG 827, Rheumatoid Arthritis

• Research type

  Research Study

• Full title

  A Long-term Assessment of the Safety and Efficacy of AMG 827 Subcutaneous Treatment in Subjects with Rheumatoid Arthritis.

• IRAS ID

  40959

• Contact name

  Andrew Ostor

• Sponsor organisation

  Amgen Inc

• Eudract number

  2009-016119-38

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to evaluate the safety of long-term exposure with AMG 827 in patients with Rheumatoid Arthritis. Patients who completed the week 16 visit of 20090061 will be eligible and meet other eligibility will be eligible to enroll in the study. Sites that participated in the 20090061 study will be eligible to participate in this long-term extension trial. Patients will participate in the study until for up to 104 weeks (or until the Investigator's recommendation of discontinuation, Amgen??s recommendation of discontinuation, the subjects?? decision to discontinue for any reason or until an administrative decision is made to close the study).

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/25

• Date of REC Opinion

  19 May 2010

• REC opinion

  Further Information Favourable Opinion