Pfizer A3921125 - 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) in Subjects with Active Psoriatic Arthritis and an Inadequate Response to at Least One TNF Inhibitor

• IRAS ID

  137944

• Contact name

  Ernest Choy

• Contact email

  choyeh@Cardiff.ac.uk

• Sponsor organisation

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

• Eudract number

  2013-001368-46

• Clinicaltrials.gov Identifier

  NCT01882439

• 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. PsA presents significant health and socioeconomic burdens for the individual and society. 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 for the treatment of adult subjects with active PsA who have had an inadequate response to at least one TNF inhibitor treatment for PsA. This study is designed to evaluate the efficacy and safety of two doses of tofacitinib as a treatment for PsA.

  This is a phase 3 randomised, multi-centre, 6-month, double-blind, placebo-controlled, parallel group study. It involves a screening period, 7 treatment visits and one follow-up visit (if required). Approximately 390 subjects will be enrolled globally at approximately 140 research sites in 15 countries.

  Subjects will be randomised in a 2:2:1:1 ratio to one of the following four parallel treatment sequences;
  * Tofacitinib 5mg twice daily
  * Tofacitinib 10mg twice daily
  * Placebo and after month 3; Tofacitinib 5mg twice daily
  * Placebo and after month 3; Tofacitinib 10mg twice daily

  Throughout the study subjects will undergo;
  - Physical examinations, vitals signs and ECG
  - Chest x-ray
  - Lab safety sampling and various assessments on blood and urine
  - PsA evaluation (examination of skin, joints, fingers/toes, spine and fingernails)
  - 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/0263

• Date of REC Opinion

  7 Jan 2014

• REC opinion

  Further Information Favourable Opinion