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Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01393639
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : August 13, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

June 13, 2011
July 13, 2011
August 13, 2014
September 2011
June 2014   (Final data collection date for primary outcome measure)
  • Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria [ Time Frame: baseline and week 8 ]
  • Change in levels of dissociation biomarker P1NP measured in blood [ Time Frame: baseline and week 8 ]
  • Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood [ Time Frame: baseline and week 8 ]
  • Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria [ Time Frame: baseline and week 8 ]
  • Change in levels of dissociation biomarker P1NP measured in blood [ Time Frame: baseline and week 8 ]
  • Change in levels of dissociation biomarker UNTx/Ucr measure in blood [ Time Frame: baseline and week 8 ]
Complete list of historical versions of study NCT01393639 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • 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 ]
  • Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 4,8,12 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Change in Disease Activity Score (DAS) 28-3 (CRP) from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2,4,6,8,12 ]
  • Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 4,8,12 ]
  • 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 ]
  • Change in Disease Activity Score (DAS)-4 (CRP) from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 2,4,6,8,12 ]
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: PF-04171327
    1 mg tablet once daily (QD) for 8 weeks
  • Drug: PF-04171327
    5 mg tablet once daily (QD) for 8 weeks
  • Drug: PF-04171327
    10 mg tablet once daily (QD) for 8 weeks
  • Drug: PF-04171327
    15 mg tablet once daily (QD) for 8 weeks
  • Drug: prednisone
    5 mg capsule once daily for 8 weeks
  • Other: prednisone
    10 mg capsule once daily for 8 weeks
  • Other: placebo
    placebo (tablet or capsule) once daily (QD) for 8 weeks
  • Experimental: PF-04171327 1 mg QD
    Intervention: Drug: PF-04171327
  • Experimental: PF-04171327 5 mg QD
    Intervention: Drug: PF-04171327
  • Experimental: PF-04171327 10 mg QD
    Intervention: Drug: PF-04171327
  • Experimental: PF-04171327 15 mg QD
    Intervention: Drug: PF-04171327
  • Active Comparator: prednisone 5 mg QD
    Intervention: Drug: prednisone
  • Active Comparator: prednisone 10 mg QD
    Intervention: Other: prednisone
  • Placebo Comparator: placebo
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
323
315
June 2014
June 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Colombia,   Czech Republic,   Germany,   Hungary,   India,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine,   United States
Canada
 
NCT01393639
A9391010
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP