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A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00938587
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: PF-04171327 10 mg Other: Prednisone Placebo Drug: PF-04171327 25 mg Drug: Prednisone 5 mg Other: Placebo for PF-04171327 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Active And Placebo-Controlled Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis
Study Start Date : October 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: PF-04171327 10 mg Drug: PF-04171327 10 mg
PF-04171327 10 mg tablet every day for 14 days

Other: Prednisone Placebo
Placebo for Prednisone 5 mg tablet every day for 14 days

Experimental: PF-04171327 25 mg Drug: PF-04171327 25 mg
PF-04171327 25 mg tablet every day for 14 days

Other: Prednisone Placebo
Placebo for Prednisone 5 mg tablet every day for 14 days

Active Comparator: Prednisone Drug: Prednisone 5 mg
Prednisone 5 mg tablet every day for 14 days

Other: Placebo for PF-04171327
Placebo for PF-04171327 every day for 14 days

Placebo Comparator: Placebo Other: Placebo
Placebo tablet every day for 14 days

Other: Placebo for PF-04171327
Placebo tablet every day for 14 days




Primary Outcome Measures :
  1. DAS28-4 (CRP) [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Tender/painful and swollen joint count [ Time Frame: 14 days ]
  2. CRP [ Time Frame: 14 days ]
  3. Health Assessment Questionnaire-Disability Index [ Time Frame: 14 days ]
  4. Patient Global Assessment of Arthritis and Arthritis Pain [ Time Frame: 14 days ]
  5. Physician Global Assessment of Arthritis [ Time Frame: 14 days ]
  6. SF-36 version 2 (acute) [ Time Frame: 14 days ]
  7. DAS28-3 [ Time Frame: 14 days ]
  8. ACR 20/50/70 responder rate [ Time Frame: 14 days ]
  9. Adverse events [ Time Frame: 42 days ]
  10. Clinical laboratory abnormalities [ Time Frame: 42 days ]
  11. Vital signs including weight [ Time Frame: 42 days ]
  12. 12-lead ECG [ Time Frame: 14 days ]
  13. MTX clearance prior to dosing and in the presence of PF-00251802 [ Time Frame: 14 days ]
  14. Pharmacodynamic effects on biomarkers [ Time Frame: 14 days ]


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:

  • Patients ≥ 18 years of age, diagnosed with rheumatoid arthritis for a minimum duration of 3 months
  • On stable dose of methotrexate for at least 6 weeks prior to screening
  • Patient must have minimum disease activity level of ≥ 6 tender/painful joints, ≥ 6 swollen joints and CRP ≥ 0.7 mg/dL
  • Not currently receiving steroid medication

Exclusion Criteria:

  • Pregnant or nursing women
  • Patients that have active infections, TB, HIV and/or Hepatitis B or C
  • Patients that have a history of intolerance or significant adverse effects with the use of glucocorticoids

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): NCT00938587


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Locations
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United States, Alabama
Pfizer Investigational Site
Anniston, Alabama, United States, 36207
United States, Florida
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32114
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
Pfizer Investigational Site
Zephyrhills, Florida, United States, 33542
United States, Illinois
Pfizer Investigational Site
Springfield, Illinois, United States, 62704
United States, Michigan
Pfizer Investigational Site
Bingham Farms, Michigan, United States, 48025
United States, Pennsylvania
Pfizer Investigational Site
Duncansville, Pennsylvania, United States, 16635
Czechia
Pfizer Investigational Site
Ceske Budejovice, Czechia, 370 01
Pfizer Investigational Site
Hostivice, Czechia, 253 01
Pfizer Investigational Site
Praha 11 - Chodov, Czechia, 148 00
Pfizer Investigational Site
Praha 4, Czechia, 140 00
Pfizer Investigational Site
Praha 4, Czechia, 140 59
Hong Kong
Pfizer Investigational Site
New Territories, Hong Kong, 0
Hungary
Pfizer Investigational Site
Bekescsaba, Hungary, 5600
Pfizer Investigational Site
Budapest, Hungary, H-1036
Pfizer Investigational Site
Debrecen, Hungary, 4032
Pfizer Investigational Site
Szolnok, Hungary, H-5000
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 120-752
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 115093
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 192242
Pfizer Investigational Site
Smolensk, Russian Federation, 214018
Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11000
Pfizer Investigational Site
Niska Banja, Serbia, 18205
Singapore
Pfizer Investigational Site
Singapore, Singapore, 529889
Slovakia
Pfizer Investigational Site
Piestany, Slovakia, 921 12
Pfizer Investigational Site
Zilina, Slovakia, 010 01
Spain
Pfizer Investigational Site
Santiago de Compostela, A Coruña, Spain, 15705
Pfizer Investigational Site
Baracaldo, Bilbao, Spain, 48903
Pfizer Investigational Site
Bilbao, Vizcaya, Spain, 48013
Pfizer Investigational Site
Sevilla, Spain, 41009
Taiwan
Pfizer Investigational Site
Taichung, Taiwan, 407
Turkey
Pfizer Investigational Site
Ankara, Turkey, 06100
Ukraine
Pfizer Investigational Site
Kharkiv, Ukraine, 61176
Pfizer Investigational Site
Kyiv, Ukraine, 04114
Pfizer Investigational Site
Lviv, Ukraine, 79011
Pfizer Investigational Site
Vinnitsa, Ukraine, 21018
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00938587     History of Changes
Other Study ID Numbers: A9391005
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Keywords provided by Pfizer:
Rheumatoid Arthritis Glucocorticoids Prednisone
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents