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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 December 6, 2018

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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Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
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
This 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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Placebo
  • Drug: PF-06651600
    200mg pill every day (QD) for 8 weeks
  • Experimental: PF-06651600
    Study Drug
    Intervention: Drug: PF-06651600
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 12, 2017
September 18, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Bulgaria,   Czechia,   Georgia,   Germany,   Hungary,   Poland,   Serbia,   Slovakia,   United States
 
 
NCT02969044
B7981006
2016-002862-30 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

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 thte study website. To get updates and notications about this trail, sign up using the form below.

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