DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: PF-04171327 (Drug); PF-04171327 (Drug); PF-04171327 (Drug); PF-04171327 (Drug); prednisone (Drug); prednisone (Other); placebo (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria

Change in levels of dissociation biomarker P1NP measured in blood

Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood

Secondary outcome:

Number of participants achieving a 20% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe

Number of participants achieving a 50% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe

Change in Disease Activity Score (DAS) 28-3 using C-reactive protein (CRP) from baseline to multiple timepoints listed in timeframe

Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe

Number of participants achieving a 70% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe

Change in Disease Activity Score (DAS)-4 using C-reactive protein(CRP) from baseline to multiple timepoints listed in timeframe

Number of participants achieving improvement according to ACR hybrid criteria from baseline to multiple timepoints listed in timeframe

Number of participants achieving improvement in individual components of the ACR criteria from baseline to multiple timepoints listed in timeframe

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Pleven 5800, Bulgaria

Pfizer Investigational Site, Plovdiv 4000, Bulgaria

Pfizer Investigational Site, Sofia 1612, Bulgaria

Pfizer Investigational Site, Bucaramanga, Santander 68001000, Colombia

Pfizer Investigational Site, Bruntal 79201, Czech Republic

Pfizer Investigational Site, Ostrava - Poruba 70800, Czech Republic

Pfizer Investigational Site, Praha 4 140 00, Czech Republic

Pfizer Investigational Site, Praha 4 140 59, Czech Republic

Pfizer Investigational Site, Berlin 13125, Germany

Pfizer Investigational Site, Berlin 10117, Germany

Pfizer Investigational Site, Frankfurt am Main 60528, Germany

Pfizer Investigational Site, Bekescsaba 5600, Hungary

Pfizer Investigational Site, Budapest 1027, Hungary

Pfizer Investigational Site, Budapest 1036, Hungary

Pfizer Investigational Site, Szolnok 5000, Hungary

Pfizer Investigational Site, Daegu 705-718, Korea, Republic of

Pfizer Investigational Site, Incheon 400-711, Korea, Republic of

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of

Pfizer Investigational Site, Seoul 143-729, Korea, Republic of

Pfizer Investigational Site, San Luis Potosi 78200, Mexico

Pfizer Investigational Site, Elblag 82-300, Poland

Pfizer Investigational Site, Nadarzyn 05-830, Poland

Pfizer Investigational Site, Sopot 81-759, Poland

Pfizer Investigational Site, Bucuresti 011172, Romania

Pfizer Investigational Site, Galati 800578, Romania

Pfizer Investigational Site, Iasi 700656, Romania

Pfizer Investigational Site, Tg Mures 540136, Romania

Pfizer Investigational Site, Barnaul 656024, Russian Federation

Pfizer Investigational Site, Ekaterinburg 620102, Russian Federation

Pfizer Investigational Site, Ekaterinburg 620149, Russian Federation

Pfizer Investigational Site, Kemerovo 650000, Russian Federation

Pfizer Investigational Site, Kemerovo 650066, Russian Federation

Pfizer Investigational Site, Moscow 115522, Russian Federation

Pfizer Investigational Site, Novosibirsk 630091, Russian Federation

Pfizer Investigational Site, Orenburg 460018, Russian Federation

Pfizer Investigational Site, Petrozavodsk 185019, Russian Federation

Pfizer Investigational Site, Ryazan 390026, Russian Federation

Pfizer Investigational Site, Saint-Petersburg 190068, Russian Federation

Pfizer Investigational Site, Saint-Petersburg 194291, Russian Federation

Pfizer Investigational Site, Saratov 410039, Russian Federation

Pfizer Investigational Site, Smolensk 214018, Russian Federation

Pfizer Investigational Site, Tomsk 634063, Russian Federation

Pfizer Investigational Site, Vladimir 600023, Russian Federation

Pfizer Investigational Site, Yaroslavl 150003, Russian Federation

Pfizer Investigational Site, Yaroslavl 150062, Russian Federation

Pfizer Investigational Site, Belgrade 11000, Serbia

Pfizer Investigational Site, Niska Banja 18205, Serbia

Pfizer Investigational Site, Dunajska Streda 92901, Slovakia

Pfizer Investigational Site, Povazska Bystrica 017 01, Slovakia

Pfizer Investigational Site, Rimavska Sobota 979 01, Slovakia

Pfizer Investigational Site, Trnava 917 01, Slovakia

Pfizer Investigational Site, Zilina 010 01, Slovakia

Pfizer Investigational Site, A Coruña 15006, Spain

Pfizer Investigational Site, Barcelona 08034, Spain

Pfizer Investigational Site, Chernivtsi 58022, Ukraine

Pfizer Investigational Site, Donetsk 83001, Ukraine

Pfizer Investigational Site, Kiev 03680, Ukraine

Pfizer Investigational Site, Kyiv 04107, Ukraine

Pfizer Investigational Site, Odesa 65025, Ukraine

Pfizer Investigational Site, Odesa 65026, Ukraine

Pfizer Investigational Site, Vinnytsya 21018, Ukraine

Pfizer Investigational Site, Zaporizhzhya 69600, Ukraine

Pfizer Investigational Site, Secunderabad, Andra Pradesh 500 003, India

Pfizer Investigational Site, Medellin, Antioquia 0000, Colombia

Pfizer Investigational Site, Medellin, Antioquia, Colombia

Pfizer Investigational Site, Tucson, Arizona 85704, United States

Pfizer Investigational Site, San Leandro, California 94578, United States

Pfizer Investigational Site, Panorama, Cape Town 7500, South Africa

Pfizer Investigational Site, Bogota, Cundinamarca 0000, Colombia

Pfizer Investigational Site, Chía, Cundinamarca 0000, Colombia

Pfizer Investigational Site, Newark, Delaware 19713, United States

Pfizer Investigational Site, Daytona Beach, Florida 32114, United States

Pfizer Investigational Site, Ormond Beach, Florida 32174, United States

Pfizer Investigational Site, Vero Beach, Florida 32960, United States

Pfizer Investigational Site, Pretoria, Gauteng 0084, South Africa

Pfizer Investigational Site, Guadalajara, Jalisco 44690, Mexico

Pfizer Investigational Site, Bangalore, Karnataka 560 054, India

Pfizer Investigational Site, Seoul, Korea 130-872, Korea, Republic of

Pfizer Investigational Site, Brooklyn, New York 11201, United States

Pfizer Investigational Site, Great Neck, New York 11021, United States

Pfizer Investigational Site, Cincinnati, Ohio 45219, United States

Pfizer Investigational Site, Ducansville, Pennsylvania 16635, United States

Pfizer Investigational Site, Ipoh, Perak 30450, Malaysia

Pfizer Investigational Site, Petaling Jaya, Selangor Darul Ehsan 46150, Malaysia

Pfizer Investigational Site, Charleston, South Carolina 29406, United States

Pfizer Investigational Site, Houston, Texas 77034, United States

Pfizer Investigational Site, Lviv, Ukraine. 79010, Ukraine

Pfizer Investigational Site, Lucknow, Uttar Pradesh 226 018, India

Pfizer Investigational Site, Spokane, Washington 99204, United States

Pfizer Investigational Site, Merida, Yucatan 97000, Mexico

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: September 2011
Last updated: August 12, 2014

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017