Pfizer A3921187- Phase 3b/4 Tofacitinib (CP-690,550-10)for RA

• Research type

  Research Study

• Full title

  A PHASE 3b/4 RANDOMIZED DOUBLE BLIND STUDY OF 5 MG OF TOFACITINIB WITH AND WITHOUT METHOTREXATE IN COMPARISON TO ADALIMUMAB WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS

• IRAS ID

  159677

• Contact name

  Robert Moots

• Contact email

  r.j.moots@liverpool.ac.uk

• Sponsor organisation

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

• Eudract number

  2014-000358-13

• Clinicaltrials.gov Identifier

  NCT02187055

• Research summary

  Rheumatoid Arthritis (RA) is a chronic and debilitating autoimmune disease characterized by inflammation and destruction of the joints, substantial disability, and a significant impact on health status and quality of life; this results in a substantial economic burden to patients and the society. There is currently no cure for RA, the current treatment options available serve to reduce inflammation in the joints, relieve pain, prevent or slow joint damage, reduce disability and provide support to help improve the quality of life.

  Tofacitinib (CP-690,550) is a new, oral drug which is being developed for the treatment of RA. It works by interfering with a signaling pathway which transmits extracellular information into the cell nucleus influencing gene expression. This study is designed to evaluate the effectiveness of Tofacitinib in comparison with two other treatment options for RA.

  This is a phase 3b/4randomised, multicentre, 12-month, double-blind study. It involves a screening period, 7 treatment visits and one follow-up visit. Approximately 1080 participants will be enrolled globally at approximately 230 research sites in 29 countries.

  Participants will be randomized in a 1:1:1 ratio to one of the following three treatment arms;
  *Tofacitinib 5 mg twice daily (oral)
  *Tofacitinib 5 mg twice daily with Methotrexate (MTX) (oral)
  * Adalimumab (subcutaneous injection) 40mg every other week with MTX (oral)

  Throughout the study subjects will undergo;
  -Physical examinations, vital signs and ECG
  -Chest x-ray
  -Lab safety sampling and various assessments on blood and urine
  -Questionnaires related to RA and quality of life
  

• REC name

  North East - York Research Ethics Committee

• REC reference

  14/NE/1103

• Date of REC Opinion

  12 Nov 2014

• REC opinion

  Further Information Favourable Opinion