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Trial record 12 of 1188 for:    Recruiting, Not yet recruiting, Available Studies | "Arthritis"

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

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ClinicalTrials.gov Identifier: NCT03486457
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Tofacitinib Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 10, 2018
Estimated Primary Completion Date : November 26, 2020
Estimated Study Completion Date : November 26, 2020


Arm Intervention/treatment
Experimental: Treatment Sequence A
Tofacitinib 5 mg BID for 6 months
Drug: Tofacitinib
tablets, 5 mg BID x 6 months

Placebo Comparator: Treatment Sequence B
Placebo for 3 months then tofacitinib 5 mg BID for 3 months
Other: Placebo
tablets, to match tofacitinib 5 mg BID x 3 months

Drug: Tofacitinib
tablets, 5 mg BID x 3 months




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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)

  9. 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.

  10. 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.

  11. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486457


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
China, Anhui
The First Affiliated Hospital of Bengbu Medical College Not yet recruiting
Bengbu, Anhui, China, 233000
China, Hunan
Zhuzhou Central Hospital Not yet recruiting
Zhuzhou, Hunan, China, 412007
China, Inner Mongolia
The First Affiliated Hospital of Baotou Medical College Not yet recruiting
Baotou, Inner Mongolia, China, 014010
China, Jiangxi
Pingxiang People's Hospital Recruiting
Pingxiang, Jiangxi, China, 337055
China, Tianjin
Tianjin Medical University General Hospital, Rheumatology and Immunology Department Recruiting
Tianjin, Tianjin, China, 300052
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03486457     History of Changes
Other Study ID Numbers: A3921234
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
psoriatic arthritis
tofacitinib

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action