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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00938587
First received: July 13, 2009
Last updated: October 29, 2011
Last verified: October 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • DAS28-4 (CRP) [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tender/painful and swollen joint count [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • CRP [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire-Disability Index [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Arthritis and Arthritis Pain [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Physician Global Assessment of Arthritis [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • SF-36 version 2 (acute) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • DAS28-3 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • ACR 20/50/70 responder rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Clinical laboratory abnormalities [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • Vital signs including weight [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
  • 12-lead ECG [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
  • MTX clearance prior to dosing and in the presence of PF-00251802 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Pharmacodynamic effects on biomarkers [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 86
Study Start Date: October 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938587

  Show 38 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00938587     History of Changes
Other Study ID Numbers: A9391005
Study First Received: July 13, 2009
Last Updated: October 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Rheumatoid Arthritis Glucocorticoids Prednisone

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Signs and Symptoms
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Prednisone
Anti-Inflammatory Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014