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Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
California Medical Research Associates Inc.
Northridge, California, 91324 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects between the ages of 18 and 75 years, inclusive

- Must have moderate-to-severe, active Rheumatoid Arthritis

- Must have had an inadequate response to Methotrexate

- Subjects may have received one approved TNF inhibiting biologic agent that was
inadequately effective and/or not tolerated

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with any acute or chronic infections or infection history

- Have acute or active chronic dermatological disorders prior to study start

- Any major illness/condition(s) or evidence of an unstable clinical condition that in
the judgment of the investigator would make the subject inappropriate for entry into
this study

- Known immunodeficiency disorder or a first degree relative with hereditary
immunodeficiency

- Any live (attenuated) vaccines or current routine household contact with anyone who
has received live (attenuated) vaccine

NCT02969044
Pfizer
Completed
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

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Descriptive Information
Brief Title  ICMJE Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Official Title  ICMJE A Phase 2a, Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center Study To Assess The Efficacy And Safety Profile Of Pf-06651600 In Subjects With Moderate To Severe Active Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Brief SummaryThis is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Placebo
  • Drug: PF-06651600
    200mg pill every day (QD) for 8 weeks
Study Arms  ICMJE
  • Experimental: PF-06651600
    Study Drug
    Intervention: Drug: PF-06651600
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 6, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2016)
60
Actual Study Completion Date  ICMJE December 12, 2017
Actual Primary Completion DateDecember 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Subjects between the ages of 18 and 75 years, inclusive
  • Must have moderate-to-severe, active Rheumatoid Arthritis
  • Must have had an inadequate response to Methotrexate
  • Subjects may have received one approved TNF inhibiting biologic agent that was inadequately effective and/or not tolerated

Exclusion Criteria

  • Subjects with any acute or chronic infections or infection history
  • Have acute or active chronic dermatological disorders prior to study start
  • Any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study
  • Known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency
  • Any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Czechia,   Georgia,   Germany,   Hungary,   Poland,   Serbia,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02969044
Other Study ID Numbers  ICMJE B7981006
2016-002862-30 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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