20090061, Randomized, Double-blind, Placebo, Multiple-dose, AMG827, RA

• Research type

  Research Study

• Full title

  A Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Rheumatoid Arthritis and an Inadequate Response to Methotrexate

• IRAS ID

  32473

• Contact name

  Andrew Ostor

• Sponsor organisation

  Amgen Ltd

• Eudract number

  2009-012566-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to evaluate the safety, tolerability and efficacy of AMG 827 injections in patients who have Rheumatoid Arthritis and not a very good response to a medication called Methotrexate. Another purpose of this study is to see how much AMG 827 is in the blood after it is taken. This will also answer the questions of what the body does to AMG 827 and how AMG 827 may affect the body.Rheumatoid Arthritis (RA) is a disease that affect the joints. Symptoms include joint stiffness, pain and swelling that can progress to deformities and loss of function of both small and large joints.AMG 827 is the investigational product, which means that it has not been approved by an appropriate regulatory agency (e.g. United States Food and Drug Administration), and it will be given by injection under the skin. Since this is a placebo-controlled study, this study will compare AMG 827 to a placebo (placebo looks like AMG 827 but doesn??t have any drug in it).The duration of the study may last up to 20 weeks. This includes a screening period of up to 30 days, 12 weeks of treatment, and a follow-up visit 4 weeks later. The first dose of study product (which might be AMG 827 or might be placebo) will be given at the baseline visit. The participant will also need to be seen at the study center by a study nurse or study doctor at study weeks 1, 2, 4, 6, 8, 10, 12, and 16.Subjects will be randomly assigned by a computer program to receive 1 of four treatments: 40, 140 or 210mg of AMG 827 or placebo. This means that subjects will have 75% chance of receiving the study drug and 25% chance of receiving the inactive placebo.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/102

• Date of REC Opinion

  2 Dec 2009

• REC opinion

  Further Information Favourable Opinion