Pfizer A3921091 - Phase 3 Tofacitinib (CP-690,550) for Active PsA

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of Tofacitinib (CP-690,550) or Adalimumab in Subjects with Active Psoriatic Arthritis

• IRAS ID

  135602

• Contact name

  Ernest Choy

• Contact email

  choyeh@Cardiff.ac.uk

• Sponsor organisation

  Pfizer Inc, 235 East 42nd Street, New York, NY10017-5755

• Eudract number

  2011-003668-55

• Clinicaltrials.gov Identifier

  NCT01877668

• Duration of Study in the UK

  2 years, 2 months, 14 days

• Research summary

  Psoriatic arthritis (PsA) is a chronic inflammatory autoimmune disease characterised by joint inflammation and destruction, psoriatic skin lesions, enthesitis (inflammation of sites where tendons or ligaments insert into bone), dactylitis (inflammation of the fingers or toes), spondylitis (inflammation of the spine), progressive disability and adverse effects on quality of life. There is currently no cure for PsA. The purpose of treatment is to control disease activity, alleviate signs and symptoms, maintain physical function, optimise quality of life, and, if possible, induce complete remission.

  Tofacitinib is being developed as a treatment for adult subjects with active PsA who have failed previous disease modifying anti-rheumatic drugs (DMARDs) such as methotrexate. This study is designed to evaluate the efficacy and safety of tofacitinib as a treatment for PsA.

  This is a phase 3 randomised, multi-centre, 12-month, double-blind, double-dummy, placebo-controlled, active-controlled parallel group study. It involves a screening period, 9 treatment visits and one follow-up visit (if required). Approximately 400 subjects will be enrolled globally at approximately 144 research sites in 15 countries.

  Subjects will be randomised in a 2:2:2:1:1 ratio to one of the following five parallel treatment sequences;
  * Tofacitinib 5mg twice daily
  * Tofacitinib 10mg twice daily
  * Adalimimab 40mg injectable every two weeks (a currently available biologic medication used as an active control)
  * Placebo and after month 3; Tofacitinib 5mg twice daily
  * Placebo and after month 3; Tofacitinib 10mg twice daily

  As this study is double-blinded, all subjects in the study will receive both oral and injectable medications during the study.

  Throughout the study subjects will undergo;
  - Physical examinations, vitals signs and ECG
  - Chest, hand and feet X-rays
  - Lab safety sampling and various assessments on blood and urine
  - Questionnaires related to psoriasis and quality of life.

  Subjects who complete the treatment period will enter follow-up or if eligible enter the long-term, open-label extension study A3921092.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  13/NE/0262

• Date of REC Opinion

  7 Jan 2014

• REC opinion

  Further Information Favourable Opinion