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

NCT ID: NCT01393639

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-27
• Study Completion Date: 2014-06-09

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PF-04171327 1 mg QD

Group Type: EXPERIMENTAL

PF-04171327

Intervention Type: DRUG

1 mg tablet once daily (QD) for 8 weeks

PF-04171327 5 mg QD

Group Type: EXPERIMENTAL

PF-04171327

Intervention Type: DRUG

5 mg tablet once daily (QD) for 8 weeks

PF-04171327 10 mg QD

Group Type: EXPERIMENTAL

PF-04171327

Intervention Type: DRUG

10 mg tablet once daily (QD) for 8 weeks

PF-04171327 15 mg QD

Group Type: EXPERIMENTAL

PF-04171327

Intervention Type: DRUG

15 mg tablet once daily (QD) for 8 weeks

prednisone 5 mg QD

Group Type: ACTIVE_COMPARATOR

prednisone

Intervention Type: DRUG

5 mg capsule once daily for 8 weeks

prednisone 10 mg QD

Group Type: ACTIVE_COMPARATOR

prednisone

Intervention Type: OTHER

10 mg capsule once daily for 8 weeks

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

placebo (tablet or capsule) once daily (QD) for 8 weeks

Interventions

PF-04171327

1 mg tablet once daily (QD) for 8 weeks

Intervention Type: DRUG

PF-04171327

5 mg tablet once daily (QD) for 8 weeks

Intervention Type: DRUG

PF-04171327

10 mg tablet once daily (QD) for 8 weeks

Intervention Type: DRUG

PF-04171327

15 mg tablet once daily (QD) for 8 weeks

Intervention Type: DRUG

prednisone

5 mg capsule once daily for 8 weeks

Intervention Type: DRUG

prednisone

10 mg capsule once daily for 8 weeks

Intervention Type: OTHER

placebo

placebo (tablet or capsule) once daily (QD) for 8 weeks

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Catalina Pointe Clinical Research, Inc.

Tucson, Arizona, United States

C. Michael Neuwelt, MD, Inc.

San Leandro, California, United States

Javed Rheumatology Associates, Inc.

Newark, Delaware, United States

Allergy, Asthma, Arthritis, and Lung Center

Daytona Beach, Florida, United States

Millennium Research

Ormond Beach, Florida, United States

Alastair C. Kennedy, MD

Vero Beach, Florida, United States

The Center for Arthritis and Rheumatism

Vero Beach, Florida, United States

Arthritis and Osteoporosis Medical Associates, PLLC

Brooklyn, New York, United States

Cincinnati Rheumatic Disease Study Group, Inc.

Cincinnati, Ohio, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Low Country Rheumatology, PA

Charleston, South Carolina, United States

Tricounty Radiology

Charleston, South Carolina, United States

Accurate Clinical Research, Inc.

Houston, Texas, United States

Arthritis Northwest, PLLC

Spokane, Washington, United States

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, , Bulgaria

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Reumalab S.A.S

Medellín, Antioquia, Colombia

Centro Integral de Reumatologia e Inmunologia CIREI

Bogota, Cundinamarca, Colombia

Preventive Care SAS

Chía, Cundinamarca, Colombia

Revmatologie Bruntal, S.R.O.

Bruntál, , Czechia

Revmatologicka ambulance

Ostrava - Poruba, , Czechia

Revmatologicka ambulance

Prague, , Czechia

Thomayerova nemocnice

Prague, , Czechia

Charite Universitaetsmedizin Berlin, Klinik fuer Rheumatologie

Berlin, , Germany

Klinische Forschung Berlin-Buch GmbH

Berlin, , Germany

CIRI GmbH

Frankfurt am Main, , Germany

Dr. Rethy Pal Korhaz es Rendelointezet, II. Reumatologia Szakrendeles

Békéscsaba, , Hungary

Budai Irgalmasrendi Korhaz, Reumatologia I.

Budapest, , Hungary

Revita Reumatologiai Rendelo

Budapest, , Hungary

Qualiclinic Kft.

Budapest, , Hungary

Fejer Megyei Szent Gyorgy Korhaz Reumatologia

Székesfehérvár, , Hungary

MAV Korhaz es Rendelointezet, Reumatologiai szakrendeles

Szolnok, , Hungary

Krishna Institute of Medical Sciences Ltd

Secunderabad, Andhra Pradesh, India

Shirdi Sai Hospital

Bangalore, Karnataka, India

Dapartment of Rheumatology

Lucknow, Uttar Pradesh, India

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

Sunway Medical Centre

Petaling Jaya, Selangor, Malaysia

Centro de Estudios de Investigacion Basica y Clinica SC.

Guadalajara, Jalisco, Mexico

Unidad de Investigacion Biomedica del CEM

Mérida, Yucatán, Mexico

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

San Luis Potosí City, , Mexico

Centrum Kliniczno-Badawcze J. Brzezicki, B. Górniakiewicz-Brzezicka Lekarze Spółka Partnerska

Elblag, , Poland

Nzoz "Lecznica Mak-Med S.C."

Nadarzyn, , Poland

Wojewodzki Zespol Reumatologiczny im. dr J. Titz-Kosko

Sopot, , Poland

Spitalul Clinic "Sfanta Maria", Clinica de Medicina Interna si Reumatologie

Bucharest, , Romania

Spitalul Clinic Judetean de Urgenta "Sfantul Apostol Andrei"

Galati, , Romania

Spitalul Clinic de Recuperare

Iași, , Romania

Spitalul Clinic Judetean de Urgenta Targu Mures, Reumatologic

Tg Mures, , Romania

GBOU VPO "Orenburg State Medical Academy of Ministry of Healthcare of Russian Federation"

Orenburg, Russian Federation, Russia

Territorial Clinical Hospital

Barnaul, , Russia

GBUZ of Kemerovo region Regional clinical hospital for was veterans

Kemerovo, , Russia

Kemerovo Regional Clinical Hospital

Kemerovo, , Russia

FSBI Scientific - Research Institute of Rheumatology RAMS n.a. V.A. Nasonova.

Moscow, , Russia

LLC Consultative and Diagnostic Rheumatological Center Healthy Joints

Novosibirsk, , Russia

Republican Hospital V.A.Baranov

Petrozavodsk, , Russia

Ryazan Regional Clinical Cardiological Dispensary

Ryazan, , Russia

Clinical Rheumatological Hospital #25

Saint Petersburg, , Russia

Clinical Hospital #122 L.G. Sokolov

Saint Petersburg, , Russia

MUZ City Clinical Hospital #12

Saratov, , Russia

Smolensk Regional Clinical Hospital

Smolensk, , Russia

Tomsk Regional Clinical Hospital

Tomsk, , Russia

Vladimir Regional Clinical Hospital

Vladimir, , Russia

Clinical Hospital of Emergency Care N.V. Soloviev

Yaroslavl, , Russia

Yaroslavl Regional Clinical Hospital

Yaroslavl, , Russia

Sverdlovsk Regional Clinical Hospital # 1

Yekaterinburg, , Russia

Municilap Institution Central Clinical Hospital 6

Yekaterinburg, , Russia

Institute of Rheumatology

Belgrade, , Serbia

Institute for treatment and rehabilitation Niska Banja

Niška Banja, , Serbia

AAGS, s.r.o. , nestatne zdravotnicke zariadenie

Dunajská Streda, , Slovakia

Nestatna reumatologicka ambulancia

Považská Bystrica, , Slovakia

Reumatologicka ambulancia, REUMEX, s.r.o.

Rimavská Sobota, , Slovakia

Reumaglobal s.r.o.

Trnava, , Slovakia

Nestatna reumatologicka ambulancia

Žilina, , Slovakia

Panorama Medical Centre

Panorama, Cape Town, South Africa

Emmed Research

Pretoria, Gauteng, South Africa

KyungHee University Hospital

Seoul, Korea, South Korea

Daegu Catholic University Medical Center, Department of Rheumatology

Daegu, , South Korea

Inha University Hospital, Medicine/Rheumatology

Incheon, , South Korea

Seoul National University Hospital, Rheumatology, Internal Medicine

Seoul, , South Korea

Konkuk University Medical Center, Department of Rheumatology

Seoul, , South Korea

Complejo Hospitalario Universitario A Coruña. Hospital Materno Infantil Teresa Herrera

A Coruña, , Spain

Hospital SANITAS CIMA.

Barcelona, , Spain

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

Vinnytsia, , Ukraine

Municipal Institution:"Zaporizhzhya Regional Clinical Hospital",Rheumatology Dep.

Zaporizhzhya, , Ukraine

Countries

United States; Bulgaria; Colombia; Czechia; Germany; Hungary; India; Malaysia; Mexico; Poland; Romania; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Ukraine

References

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.

Reference Type: DERIVED

PMID: 31168411 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9391010&StudyName=Study%20Comparing%20Doses%20Of%20An%20Experimental%20Glucocorticoid%20Compound%20To%20Prednisone%20And%20Placebo%20In%20Rheumatoid%20Arthritis%20

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

Other Identifiers

2010-023782-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A9391010

Identifier Type: -

Identifier Source: org_study_id