Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis - Full Text View

Purpose

The purpose of this study is to compare the safety and efficacy of multiple doses of PF-04171327, an experimental glucocorticoid drug, to prednisone at 5 mg or 10 mg and placebo in the treatment of rheumatoid arthritis. All subjects will also be receiving background treatment of methotrexate for their rheumatoid arthritis. Study medication will be given for eight weeks followed by a 4 week period during which the dose of study medication will be gradually reduced. The efficacy of the study medications will be determined by assessing severity of the rheumatoid arthritis during the study and safety will be determined by adverse event reporting, laboratory tests and biomarker analysis.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: PF-04171327 Drug: prednisone Other: prednisone Other: placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Double Blind Assessment Of Efficacy And Safety Of PF-04171327 (1, 5, 10, 15 Mg Dose, Daily) Compared To 5 Mg And 10 Mg Prednisone Daily And Placebo Daily In Subjects With Rheumatoid Arthritis Over An 8 Week Period Followed By A 4 Week Period Of Tapering Of Study Drug

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis Steroids

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria [ Time Frame: baseline and week 8 ] [ Designated as safety issue: No ]
Change in levels of dissociation biomarker P1NP measured in blood [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]
Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood [ Time Frame: baseline and week 8 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of participants achieving a 20% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2, 4, 12 ] [ Designated as safety issue: No ]
Number of participants achieving a 50% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2,4,6,8,12 ] [ Designated as safety issue: No ]
Change in Disease Activity Score (DAS) 28-3 using C-reactive protein (CRP) from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2,4,6,8,12 ] [ Designated as safety issue: No ]
Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 4,8,12 ] [ Designated as safety issue: No ]
Number of participants achieving a 70% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2,4,6,8,12 ] [ Designated as safety issue: No ]
Change in Disease Activity Score (DAS)-4 using C-reactive protein(CRP) from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2,4,6,8,12 ] [ Designated as safety issue: No ]
Number of participants achieving improvement according to ACR hybrid criteria from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2,4,6,8,12 ] [ Designated as safety issue: No ]
Number of participants achieving improvement in individual components of the ACR criteria from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2,4,6,8,12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	315
Study Start Date:	September 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PF-04171327 1 mg QD	Drug: PF-04171327 1 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 5 mg QD	Drug: PF-04171327 5 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 10 mg QD	Drug: PF-04171327 10 mg tablet once daily (QD) for 8 weeks
Experimental: PF-04171327 15 mg QD	Drug: PF-04171327 15 mg tablet once daily (QD) for 8 weeks
Active Comparator: prednisone 5 mg QD	Drug: prednisone 5 mg capsule once daily for 8 weeks
Active Comparator: prednisone 10 mg QD	Other: prednisone 10 mg capsule once daily for 8 weeks
Placebo Comparator: placebo	Other: placebo placebo (tablet or capsule) once daily (QD) for 8 weeks

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must have documented rheumatoid arthritis with a duration of at least 3 months as determined by the investigator using standardly accepted criteria, must have been receiving methotrexate for at least 3 months to treat their rheumatoid arthritis, and must be free of any signs or symptoms of infection.

Exclusion Criteria:

Subjects cannot enter the study if they have recently received treatment with certain medications which might interfere with study medications;
subjects cannot enter if they have abnormalities in certain blood tests, history of cancer, recent bone fracture or other significant conditions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01393639

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 86 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:	NCT01393639 History of Changes
Other Study ID Numbers:	A9391010
Study First Received:	June 13, 2011
Last Updated:	June 4, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

treatment of rheumatoid arthritis
treatment of RA
patients on methotrexate for rheumatoid arthritis
prednisone for rheumatoid arthritis

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
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 June 18, 2013