Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03486457
Previous Study | Return to List | Next Study

Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03486457
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 5, 2018
First Posted Date  ICMJE April 3, 2018
Last Update Posted Date July 12, 2019
Actual Study Start Date  ICMJE August 10, 2018
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
Number of Participants With an American College of Rheumatology 50% (ACR50) Response [ Time Frame: Month 3 ]
ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03486457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
  • Number of Participants With an American College of Rheumatology 50% (ACR50) Response [ Time Frame: Week 2, Month 1, Month 4, Month 6 ]
    ACR50 response: greater than or equal to (≥) 50 percent (%) improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of 5 remaining ACR core measures: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).
  • Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response [ Time Frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 6 ]
    ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP).
  • Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Week 2, Month1, Month 2, Month 3, Month 4, Month 6 ]
    ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: Patient's Assessment of Arthritis Pain (VAS); Patient's Global Assessment of Arthritis (VAS); Physician's Global Assessment of Arthritis (VAS); Health Assessment Questionnaire - Disability Index (HAQ DI); and C-Reactive Protein (CRP) at each visit.
  • Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Month 1, Month 3, Month 6 ]
    PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 scores could worsen.
  • Physician Global Assessment (PGA) of Psoriasis Score [ Time Frame: Month 1, Month 3, Month 6 ]
    PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.
  • Psoriasis Area and Severity Index (PASI) [ Time Frame: Month 1, Month 3, Month 6 ]
    PASI score ranges from 0 to 72, with higher scores representing greater severity of psoriasis
  • Dactylitis severity score [ Time Frame: Month 1, Month 3, Month 6 ]
    Dactyltis score based upon digit tenderness for each digit of hands and feet ranges from 0-60
  • Enthesitis score based upon Leeds Enthesitis Index (LEI) [ Time Frame: Month 1, Month 3, Month 6 ]
    Enthesitis score based upon presence/absence of enthesitis at 6 sites (LEI)
  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Month 1, Month 3, Month 6 ]
    The SF 36 v.2 (Acute) is a 36 item generic health status measure. It measures 8 general health domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. These domains can also be summarized as physical and mental component summary scores.
  • Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [ Time Frame: Month 1, Month 3, Month 6 ]
    The EuroQol EQ 5D Health State Profile is a copyrighted, patient completed instrument designed to assess impact on health related quality of life in five domains: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Additionally, scores from the five domains may be used to calculate a single index value, also known as a utility score. The validity and reliability of the EuroQol EQ 5D has been established in a number of disease states, including PsA and rheumatoid arthritis.
  • Health Assessment Questionnaire Disability Index (HAQ DI) [ Time Frame: Week 2, Month 1, Month 2, Month 3, Month 4, Month 6 ]
    The HAQ DI assesses the degree of difficulty a subject has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB (CP-690,550) IN CHINESE SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE CONVENTIONAL SYNTHETIC DMARD
Brief Summary This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating signs and symptoms and improving physical function in Chinese patients with active psoriatic arthritis and had inadequate response to a conventional synthetic disease modifying anti-rheumatic drug. This is a China alone study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Drug: Tofacitinib
    tablets, 5 mg BID x 6 months
  • Other: Placebo
    tablets, to match tofacitinib 5 mg BID x 3 months
  • Drug: Tofacitinib
    tablets, 5 mg BID x 3 months
Study Arms  ICMJE
  • Experimental: Treatment Sequence A
    Tofacitinib 5 mg BID for 6 months
    Intervention: Drug: Tofacitinib
  • Placebo Comparator: Treatment Sequence B
    Placebo for 3 months then tofacitinib 5 mg BID for 3 months
    Interventions:
    • Other: Placebo
    • Drug: Tofacitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2018)
195
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2018)
153
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date February 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chinese patients
  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
  • Active plaque psoriasis at screening
  • Inadequate response to at least one conventional synthetic DMARD

Exclusion Criteria:

  • Non-plaque forms of psoriasis (with exception of nail psoriasis)
  • History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03486457
Other Study ID Numbers  ICMJE A3921234
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP