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

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01393639
• Other study ID #: A9391010
• Secondary ID: 2010-023782-22
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: June 2014

Study information

• Verified date: December 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• PF-04171327
1 mg tablet once daily (QD) for 8 weeks
• PF-04171327
5 mg tablet once daily (QD) for 8 weeks
• PF-04171327
10 mg tablet once daily (QD) for 8 weeks
• PF-04171327
15 mg tablet once daily (QD) for 8 weeks
• prednisone
5 mg capsule once daily for 8 weeks

Other:
• prednisone
10 mg capsule once daily for 8 weeks
• placebo
placebo (tablet or capsule) once daily (QD) for 8 weeks

Locations

Country	Name	City	State
Bulgaria	Revmatologichen kabinet, DKTs Sv. Pantaleimon OOD	Pleven
Bulgaria	Revmatologichno Otdelenie, MBAL - Plovdiv	Plovdiv
Bulgaria	MBAL "Sveti Ivan Rilski" Sofia; Klinika po Revmatologia	Sofia
Bulgaria	MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia	Sofia
Colombia	Centro Integral de Reumatologia e Inmunologia CIREI	Bogota	Cundinamarca
Colombia	Preventive Care SAS	Chía	Cundinamarca
Colombia	Hospital Pablo Tobon Uribe	Medellin	Antioquia
Colombia	Reumalab S.A.S	Medellin	Antioquia
Czechia	Revmatologie Bruntal, S.R.O.	Bruntal
Czechia	Revmatologicka ambulance	Ostrava - Poruba
Czechia	Revmatologicka ambulance	Praha 4
Czechia	Thomayerova nemocnice	Praha 4
Germany	Charite Universitaetsmedizin Berlin, Klinik fuer Rheumatologie	Berlin
Germany	Klinische Forschung Berlin-Buch GmbH	Berlin
Germany	CIRI GmbH	Frankfurt am Main
Hungary	Dr. Rethy Pal Korhaz es Rendelointezet, II. Reumatologia Szakrendeles	Bekescsaba
Hungary	Budai Irgalmasrendi Korhaz, Reumatologia I.	Budapest
Hungary	Qualiclinic Kft.	Budapest
Hungary	Revita Reumatologiai Rendelo	Budapest
Hungary	Fejer Megyei Szent Gyorgy Korhaz Reumatologia	Szekesfehervar
Hungary	MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles	Szolnok
India	Shirdi Sai Hospital	Bangalore	Karnataka
India	Dapartment of Rheumatology	Lucknow	Uttar Pradesh
India	Krishna Institute of Medical Sciences Ltd	Secunderabad	Andra Pradesh
Korea, Republic of	Daegu Catholic University Medical Center, Department of Rheumatology	Daegu
Korea, Republic of	Inha University Hospital, Medicine/Rheumatology	Incheon
Korea, Republic of	Konkuk University Medical Center, Department of Rheumatology	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul	Korea
Korea, Republic of	Seoul National University Hospital, Rheumatology, Internal Medicine	Seoul
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh	Perak
Malaysia	Sunway Medical Centre	Petaling Jaya	Selangor Darul Ehsan
Mexico	Centro de Estudios de Investigacion Basica y Clinica SC.	Guadalajara	Jalisco
Mexico	Unidad de Investigacion Biomedica del CEM	Merida	Yucatan
Mexico	Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.	San Luis Potosi
Poland	Centrum Kliniczno-Badawcze J. Brzezicki, B. Górniakiewicz-Brzezicka Lekarze Spólka Partnerska	Elblag
Poland	Nzoz "Lecznica Mak-Med S.C."	Nadarzyn
Poland	Wojewodzki Zespol Reumatologiczny im. dr J. Titz-Kosko	Sopot
Romania	Spitalul Clinic "Sfanta Maria", Clinica de Medicina Interna si Reumatologie	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta "Sfantul Apostol Andrei"	Galati
Romania	Spitalul Clinic de Recuperare	Iasi
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures, Reumatologic	Tg Mures
Russian Federation	Territorial Clinical Hospital	Barnaul
Russian Federation	Municilap Institution Central Clinical Hospital 6	Ekaterinburg
Russian Federation	Sverdlovsk Regional Clinical Hospital # 1	Ekaterinburg
Russian Federation	GBUZ of Kemerovo region Regional clinical hospital for was veterans	Kemerovo
Russian Federation	Kemerovo Regional Clinical Hospital	Kemerovo
Russian Federation	FSBI Scientific - Research Institute of Rheumatology RAMS n.a. V.A. Nasonova.	Moscow
Russian Federation	LLC Consultative and Diagnostic Rheumatological Center Healthy Joints	Novosibirsk
Russian Federation	GBOU VPO "Orenburg State Medical Academy of Ministry of Healthcare of Russian Federation"	Orenburg
Russian Federation	Republican Hospital V.A.Baranov	Petrozavodsk
Russian Federation	Ryazan Regional Clinical Cardiological Dispensary	Ryazan
Russian Federation	Clinical Hospital #122 L.G. Sokolov	Saint-Petersburg
Russian Federation	Clinical Rheumatological Hospital #25	Saint-Petersburg
Russian Federation	MUZ City Clinical Hospital #12	Saratov
Russian Federation	Smolensk Regional Clinical Hospital	Smolensk
Russian Federation	Tomsk Regional Clinical Hospital	Tomsk
Russian Federation	Vladimir Regional Clinical Hospital	Vladimir
Russian Federation	Clinical Hospital of Emergency Care N.V. Soloviev	Yaroslavl
Russian Federation	Yaroslavl Regional Clinical Hospital	Yaroslavl
Serbia	Institute of Rheumatology	Belgrade
Serbia	Institute for treatment and rehabilitation Niska Banja	Niska Banja
Slovakia	AAGS, s.r.o. , nestatne zdravotnicke zariadenie	Dunajska Streda
Slovakia	Nestatna reumatologicka ambulancia	Povazska Bystrica
Slovakia	Reumatologicka ambulancia, REUMEX, s.r.o.	Rimavska Sobota
Slovakia	Reumaglobal s.r.o.	Trnava
Slovakia	Nestatna reumatologicka ambulancia	Zilina
South Africa	Panorama Medical Centre	Panorama	Cape Town
South Africa	Emmed Research	Pretoria	Gauteng
Spain	Hospital SANITAS CIMA.	Barcelona
Spain	Complejo Hospitalario Universitario A Coruña. Hospital Materno Infantil Teresa Herrera	La Coruna
Ukraine	Municipal Medical Institution "City Clinical Hospital #3"	Chernivtsi
Ukraine	Municipal Medicoprophylactic Institution "Donetsk City Clinical Hospital #5".	Donetsk
Ukraine	National Scientific Centre "Institute of Cardiology n.a. M.D. Strazheska of NAMS of Ukraine".	Kiev
Ukraine	Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"	Kyiv
Ukraine	Komunalnyi zaklad Lvivskoi oblasnoi rady "Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr"	Lviv
Ukraine	Komunalna ustanova "Odeska oblasna klinichna likarnia"	Odesa
Ukraine	Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology	Odesa
Ukraine	Vinnytsya regional clinical hospital named after M.I. Pyrogova; Department of rheumatology	Vinnytsya
Ukraine	Municipal Institution:"Zaporizhzhya Regional Clinical Hospital",Rheumatology Dep.	Zaporizhzhya
United States	Arthritis and Osteoporosis Medical Associates, PLLC	Brooklyn	New York
United States	Low Country Rheumatology, PA	Charleston	South Carolina
United States	Tricounty Radiology	Charleston	South Carolina
United States	Cincinnati Rheumatic Disease Study Group, Inc.	Cincinnati	Ohio
United States	Allergy, Asthma, Arthritis, and Lung Center	Daytona Beach	Florida
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	Accurate Clinical Research, Inc.	Houston	Texas
United States	Javed Rheumatology Associates, Inc.	Newark	Delaware
United States	Millennium Research	Ormond Beach	Florida
United States	C. Michael Neuwelt, MD, Inc.	San Leandro	California
United States	Arthritis Northwest, PLLC	Spokane	Washington
United States	Catalina Pointe Clinical Research, Inc.	Tucson	Arizona
United States	Alastair C. Kennedy, MD	Vero Beach	Florida
United States	The Center for Arthritis and Rheumatism	Vero Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Colombia,  Czechia,  Germany,  Hungary,  India,  Korea, Republic of,  Malaysia,  Mexico,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants achieving a 20% improvement in American College of Rheumatology (ACR) criteria		baseline and week 8
Primary	Change in levels of dissociation biomarker P1NP measured in blood		baseline and week 8
Primary	Change in levels of dissociation biomarker urinary N-telopeptide/urinary creatinine ration (UNTx/Ucr) measure in blood		baseline and week 8
Secondary	Number of participants achieving a 20% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe		baseline and Week 2, 4, 12
Secondary	Number of participants achieving a 50% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe		baseline and Week 2,4,6,8,12
Secondary	Change in Disease Activity Score (DAS) 28-3 using C-reactive protein (CRP) from baseline to multiple timepoints listed in timeframe		baseline and Week 2,4,6,8,12
Secondary	Change in SF-36 (Quality of Life) score from baseline to multiple timepoints listed in timeframe		baseline and Week 4,8,12
Secondary	Number of participants achieving a 70% improvement according to ACR criteria from baseline to multiple timepoints listed in timeframe		baseline and Week 2,4,6,8,12
Secondary	Change in Disease Activity Score (DAS)-4 using C-reactive protein(CRP) from baseline to multiple timepoints listed in timeframe		baseline and Week 2,4,6,8,12
Secondary	Number of participants achieving improvement according to ACR hybrid criteria from baseline to multiple timepoints listed in timeframe		baseline and Week 2,4,6,8,12
Secondary	Number of participants achieving improvement in individual components of the ACR criteria from baseline to multiple timepoints listed in timeframe		baseline and Week 2,4,6,8,12

External Links

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