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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00938587

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:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Prednisone

U.S. FDA Resources

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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

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
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2012