AK106 II-01 Final Version 01

• Research type

  Research Study

• Full title

  A Phase IIa, Multi-Centre, Randomized, Double-Blind, Two-Part, Controlled, Repeated-Dose Study of AK106-001616 in Patients with Rheumatoid Arthritis

• Sponsor organisation

  Asahi Kasei Pharma Corporation

• Eudract number

  2008-006075-75

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a two-part study designed to investigate whether the study drug (AK106-001616) has any clinical interaction with oral Methotrexate (Part 1) and also to investigate the clinical efficacy of AK106-001616 (Part 2). Part 1 of the study is a dose escalating design (3 doses: low, middle and high) and will involve residential stays on 4 occasions throughout the study. Blood samples will be taken at pre-determined timepoints for determination of concentrations of methotrexate and study drug in the blood. Urine will also be collected for determination of concentrations of methotrexate and biomarkers in the urine. A total of 30 patients globally will be randomised to Part 1 of the study.Part 2 of the study is a 28 day repeated dose study at a dose level to be determined following the outcome of Part 1 . Primary endpoints will be the clinical assessments of Rheumatoid Arthritis (RA) and the concentrations of RA biomarkers in the urine. The safety and efficacy of the study drug will be compared with the marketed product Naproxen. A total of 100 patients globally will be randomised to Part 2 of the study.

• REC name

  Scotland A REC

• REC reference

  09/MRE00/21

• Date of REC Opinion

  14 Apr 2009

• REC opinion

  Further Information Favourable Opinion