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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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: PF-04171327 Drug: prednisone Other: prednisone Other: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria [ Time Frame: baseline and week 8 ]
  2. Change in levels of dissociation biomarker P1NP measured in blood [ Time Frame: baseline and week 8 ]
  3. Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood [ Time Frame: baseline and week 8 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe [ Time Frame: baseline and Week 4,8,12 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01393639


  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Tucson, Arizona, United States, 85704
United States, California
Pfizer Investigational Site
San Leandro, California, United States, 94578
United States, Delaware
Pfizer Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32114
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
Pfizer Investigational Site
Vero Beach, Florida, United States, 32960
United States, New York
Pfizer Investigational Site
Brooklyn, New York, United States, 11201
Pfizer Investigational Site
Great Neck, New York, United States, 11021
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
United States, Pennsylvania
Pfizer Investigational Site
Ducansville, Pennsylvania, United States, 16635
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29406
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77034
United States, Washington
Pfizer Investigational Site
Spokane, Washington, United States, 99204
Bulgaria
Pfizer Investigational Site
Pleven, Bulgaria, 5800
Pfizer Investigational Site
Plovdiv, Bulgaria, 4000
Pfizer Investigational Site
Sofia, Bulgaria, 1612
Colombia
Pfizer Investigational Site
Medellin, Antioquia, Colombia, 0000
Pfizer Investigational Site
Medellin, Antioquia, Colombia, 0
Pfizer Investigational Site
Bogota, Cundinamarca, Colombia, 0000
Pfizer Investigational Site
Chía, Cundinamarca, Colombia, 0000
Pfizer Investigational Site
Bucaramanga, Santander, Colombia, 68001000
Czech Republic
Pfizer Investigational Site
Bruntal, Czech Republic, 79201
Pfizer Investigational Site
Ostrava - Poruba, Czech Republic, 70800
Pfizer Investigational Site
Praha 4, Czech Republic, 140 00
Pfizer Investigational Site
Praha 4, Czech Republic, 140 59
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Berlin, Germany, 13125
Pfizer Investigational Site
Frankfurt am Main, Germany, 60528
Hungary
Pfizer Investigational Site
Bekescsaba, Hungary, 5600
Pfizer Investigational Site
Budapest, Hungary, 1027
Pfizer Investigational Site
Budapest, Hungary, 1036
Pfizer Investigational Site
Szolnok, Hungary, 5000
India
Pfizer Investigational Site
Secunderabad, Andra Pradesh, India, 500 003
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 054
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India, 226 018
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Korea, Republic of, 130-872
Pfizer Investigational Site
Daegu, Korea, Republic of, 705-718
Pfizer Investigational Site
Incheon, Korea, Republic of, 400-711
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 143-729
Malaysia
Pfizer Investigational Site
Ipoh, Perak, Malaysia, 30450
Pfizer Investigational Site
Petaling Jaya, Selangor Darul Ehsan, Malaysia, 46150
Mexico
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44690
Pfizer Investigational Site
Merida, Yucatan, Mexico, 97000
Pfizer Investigational Site
San Luis Potosi, Mexico, 78200
Poland
Pfizer Investigational Site
Elblag, Poland, 82-300
Pfizer Investigational Site
Nadarzyn, Poland, 05-830
Pfizer Investigational Site
Sopot, Poland, 81-759
Romania
Pfizer Investigational Site
Bucuresti, Romania, 011172
Pfizer Investigational Site
Galati, Romania, 800578
Pfizer Investigational Site
Iasi, Romania, 700656
Pfizer Investigational Site
Tg Mures, Romania, 540136
Russian Federation
Pfizer Investigational Site
Barnaul, Russian Federation, 656024
Pfizer Investigational Site
Ekaterinburg, Russian Federation, 620102
Pfizer Investigational Site
Ekaterinburg, Russian Federation, 620149
Pfizer Investigational Site
Kemerovo, Russian Federation, 650000
Pfizer Investigational Site
Kemerovo, Russian Federation, 650066
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Novosibirsk, Russian Federation, 630091
Pfizer Investigational Site
Orenburg, Russian Federation, 460018
Pfizer Investigational Site
Petrozavodsk, Russian Federation, 185019
Pfizer Investigational Site
Ryazan, Russian Federation, 390026
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 190068
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 194291
Pfizer Investigational Site
Saratov, Russian Federation, 410039
Pfizer Investigational Site
Smolensk, Russian Federation, 214018
Pfizer Investigational Site
Tomsk, Russian Federation, 634063
Pfizer Investigational Site
Vladimir, Russian Federation, 600023
Pfizer Investigational Site
Yaroslavl, Russian Federation, 150003
Pfizer Investigational Site
Yaroslavl, Russian Federation, 150062
Serbia
Pfizer Investigational Site
Belgrade, Serbia, 11000
Pfizer Investigational Site
Niska Banja, Serbia, 18205
Slovakia
Pfizer Investigational Site
Dunajska Streda, Slovakia, 92901
Pfizer Investigational Site
Povazska Bystrica, Slovakia, 017 01
Pfizer Investigational Site
Rimavska Sobota, Slovakia, 979 01
Pfizer Investigational Site
Trnava, Slovakia, 917 01
Pfizer Investigational Site
Zilina, Slovakia, 010 01
South Africa
Pfizer Investigational Site
Panorama, Cape Town, South Africa, 7500
Pfizer Investigational Site
Pretoria, Gauteng, South Africa, 0084
Spain
Pfizer Investigational Site
A Coruña, Spain, 15006
Pfizer Investigational Site
Barcelona, Spain, 08034
Ukraine
Pfizer Investigational Site
Lviv, Ukraine., Ukraine, 79010
Pfizer Investigational Site
Chernivtsi, Ukraine, 58022
Pfizer Investigational Site
Donetsk, Ukraine, 83001
Pfizer Investigational Site
Kiev, Ukraine, 03680
Pfizer Investigational Site
Kyiv, Ukraine, 04107
Pfizer Investigational Site
Odesa, Ukraine, 65025
Pfizer Investigational Site
Odesa, Ukraine, 65026
Pfizer Investigational Site
Vinnytsya, Ukraine, 21018
Pfizer Investigational Site
Zaporizhzhya, Ukraine, 69600
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01393639     History of Changes
Other Study ID Numbers: A9391010
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

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