Safety and Efficacy of Etanercept, Amendment 1 dated 10 Jan 2008

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind Study Comparing the Safety and Efficacy of Once-Weekly Administration of Etanercept 50 mg, Etanercept 25 mg, and Placebo in Combination With Methotrexate in Subjects With Moderately Active Rheumatoid Arthritis Who Have Achieved an Adequate Response With Etanercept 50 mg Once Weekly and methotrexate

• IRAS ID

  2226

• Sponsor organisation

  Wyeth Pharmaceuticals Inc

• Eudract number

  2007-000896-41

• Clinicaltrials.gov Identifier

  NCT00565409

• Research summary

  This rheumatoid arthritis (RA) study will compare the efficacy of etanercept 50 mg once weekly plus Methotrexate, etanercept 25 mg once weekly plus MTX, and MTX monotherapy in subjects who initially had moderate disease activity and achieved low disease activity or remission with etanercept 50 mg once weekly plus MTX. Subjects with RA who have moderate disease activity will be enrolled because this group represents a large group of the RA population who are more likely to maintain a low disease activity state with discontinuing etanercept or reducing the dose than subjects with high disease activity and long-standing disease. Before discontinuing or reducing the dose of etanercept, subjects will be required to sustain a low disease activity state for at least 6 months. For RA subjects a long-term therapy is required, and continued combination therapy is likely to provide the optimal benefit, although this study will obtain data that will quantify the benefit of etanercept dose discontinuation or reduction. This study will be a step in the ongoing process of understanding the optimal way to treat patients with moderate disease activity once low disease or remission is achieved. Subject's pain, stiffness, symptoms, fatigue level, sleep, general health and quality of life will be assessed throughout the study.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  08/H1005/107

• Date of REC Opinion

  12 Jan 2009

• REC opinion

  Further Information Favourable Opinion