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A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

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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 ]


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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


  Show 38 Study Locations
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