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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01393639
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 13, 2011
First Posted Date  ICMJE July 13, 2011
Last Update Posted Date December 14, 2018
Actual Study Start Date  ICMJE September 2011
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Doses Of An Experimental Glucocorticoid Compound To Prednisone And Placebo In Rheumatoid Arthritis
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Buttgereit F, Strand V, Lee EB, Simon-Campos A, McCabe D, Genet A, Tammara B, Rojo R, Hey-Hadavi J. Fosdagrocorat (PF-04171327) versus prednisone or placebo in rheumatoid arthritis: a randomised, double-blind, multicentre, phase IIb study. RMD Open. 2019 Apr 16;5(1):e000889. doi: 10.1136/rmdopen-2018-000889. eCollection 2019.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2014)		 323
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2011)		 315
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Colombia,   Czechia,   Germany,   Hungary,   India,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Romania,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine,   United States
Removed Location Countries Canada,   Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01393639
Other Study ID Numbers  ICMJE A9391010
2010-023782-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pfizer
Original Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018

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