B3281001 - Pfizer

• Research type

  Research Study

• Full title

  A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES

• IRAS ID

  108265

• Contact name

  Paul Emery

• Sponsor organisation

  Pfizer Inc., 235 East 42nd Street, New York, NY 10017

• Eudract number

  2011-002896-40

• Clinicaltrials.gov Identifier

  NCT01526057

• Research summary

  The purpose of this research study is to investigate whether a new drug, PF-05280586, is similar in several major ways to a drug that is already available, rituximab. The reason for developing a drug that is similar to rituximab is to give future patients, who could benefit from treatment with rituximab, a less expensive alternative. Rituximab is a prescription medicine which is given together with methotrexate for the treatment of patients with Rheumatoid Arthritis (RA) . Rituximab is given to RA patients who have not responded well to a drug called a TNF inhibitor. RA is a disease of the joints. B lymphocytes are involved in the cause of some of the symptoms of RA. Rituximab is used to treat RA in people who have already tried some other medicines which have either stopped working, have not worked well enough or have caused side effects. Rituximab slows down the damage to joints caused by RA and improves the patient??s ability to do normal daily activities. Rituximab is usually taken together with another medicine called methotrexate. This study will test whether the body processes PF-05280586 and rituximab similarly. The study will compare PF-05280586 to two different kinds of rituximab that are already available to be prescribed for patients in different parts of the world, Rituxan© and MabThera©. This is the first test of the experimental drug PF-05280586 in patients. PF-05280586 will be given to patients for the first time in this study. There will be about 210 people enrolled in this study. The study is expected to be done at about 75 different research sites in approximately 15 countries. About 3-5 people may be enrolled at each site in the UK. The duration of this study will be 6 months for most patients.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  12/LO/1129

• Date of REC Opinion

  14 Aug 2012

• REC opinion

  Further Information Favourable Opinion