A Phase 3, Multi Site, Randomized, Double Blind, Placebo Controlled Study Of The Efficacy And Safety Comparing CP- 690,550 And Etanercept In Subjects With Moderate To Severe Chronic Plaque Psoriasis

NCT ID: NCT01241591

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2013-01-31

Brief Summary

To evaluate the efficacy of CP-690,550 as compared to etanercept and the safety of CP-690,550 for treatment of moderate to severe chronic plaque psoriasis.

Conditions

Psoriasis

Keywords

CP-690,550; Etanercept; Moderate; Severe; Chronic; Plaque; Psoriasis; Efficacy; Safety; Tofacitinib; Xeljanz; OPT Compare; OPT; head-to-head; non-inferiority; Psoriasis vulgaris; short-term; Itch; Pruritus; Plaque psoriasis; DLQI

Study Design

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

Study Groups

CP 690,550 5 mg BID+Placebo BIW

Group Type: EXPERIMENTAL

CP 690,550 5 mg

Intervention Type: DRUG

CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks

CP 690,550 10 mg BID+Placebo BIW

Group Type: EXPERIMENTAL

CP 690,550 10 mg

Intervention Type: DRUG

CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks

Placebo BID+Etanercept 50 mg BIW

Group Type: ACTIVE_COMPARATOR

Etanercept 50 mg

Intervention Type: BIOLOGICAL

Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks

Placebo BID+Placebo BIW

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.

Interventions

CP 690,550 5 mg

CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks

Intervention Type: DRUG

CP 690,550 10 mg

CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks

Intervention Type: DRUG

Etanercept 50 mg

Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks

Intervention Type: BIOLOGICAL

Placebo

Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Have had a diagnosis of plaque type psoriasis (psoriasis vulgaris);
• Have plaque-type psoriasis covering at least 10% of total body surface area
• Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis

Exclusion Criteria

• Non-plaque or drug induced forms of psoriasis
• Cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis
• Cannot discontinue phototherapy
• Any uncontrolled significant medical condition

• 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

Centro de Investigaciones Dermatologicas

Buenos Aires, C1114aap, Argentina

Centro de Investigaciones Dermatologicas

Buenos Aires, , Argentina

IMAI (Instituto Medico de Asistencia e Investigaciones)

Buenos Aires, , Argentina

LKH Feldkirch Abteilung fuer Dermatologie und Venerologie

Feldkirch, , Austria

LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie

Innsbruck, , Austria

LKH Salzburg, Landesklinik fuer Dermatologie

Salzburg, , Austria

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel

Vienna, , Austria

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Department for skin and venerial diseases, Clinical Center University of Sarajevo

Sarajevo, , Bosnia and Herzegovina

Universitetska Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Dr Georgi Stranski- Pleven

Pleven, , Bulgaria

Tsentar za kozhno-venericheski zaboliavania" EOOD

Sofia, , Bulgaria

Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia

Sofia, , Bulgaria

Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia

Sofia, , Bulgaria

MBAL na Voennomeditsinska akademia- Sofia

Sofia, , Bulgaria

Centro de Especialidades Dermatologicas

Viña del Mar, Región de Valparaíso, Chile

Clinica Davila

Santiago, Rm 8431657, RM, Chile

Clinica Dermovein S.A.

Santiago, , Chile

Hospital Clinico Universidad de Chile, Departamento Dermatologia

Santiago, , Chile

Reumalab S.A.S.

Medellín, Antioquia, Colombia

Centro Integral de Reumatología del Caribe Circaribe S.A

Barranquilla, Atlántico, Colombia

Centro de Investigacion Clinica de la Universidad del Rosario

Bogota, Cundinamarca, Colombia

Riesgo de Fractura S.A.

Bogota, Cundinamarca, Colombia

Medicity S.A.S

Bucaramanga, Santander Department, Colombia

Department of Dermatovenerology, University Hospital Center Osijek

Osijek, , Croatia

Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"

Zagreb, , Croatia

Department of dermatovenerology, University Hospital Center Zagreb

Zagreb, , Croatia

Nemocnice Ceske Budejovice, a.s.

České Budějovice, , Czechia

FN Kradec Kralove

Hradec Králové, , Czechia

Fakultni nemocnice Plzen

Plzen - Bory, , Czechia

Kozni ordinace

Prague, , Czechia

Kralska zdravotni a.s., Masarykovy nemocnice o.z.

Ústí nad Labem, , Czechia

Kralska zdravotni

Ústí nad Labem, , Czechia

Department of Dermatology, Aarhus University Hospital

Aarhus C, , Denmark

Bispebjerg Hospital, University of Copenhagen

Copenhagen NV, , Denmark

Hudklinikken Herning

Herning, , Denmark

CHG Le Mans

Le Mans, Cedex 09, France

CHU de Besancon - Hopital Saint Jacques

Besançon, , France

Hopital Ambroise Pare, Service de Dermatologie

Boulogne, , France

Chu Morvan

Brest Cédex, , France

Hopital Dupuytren

Limoges, , France

Hopital Fournier

Nancy Cédex, , France

CHU de Nantes - Hotel Dieu

Nantes, , France

CHU de NICE - Hôpital de l'Archet II

Nice, , France

Hopital Saint-Louis

Paris, , France

Hôpital Bichat

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

C.H.U. de Poitiers

Poitiers, , France

Hopital Robert Debre

Reims, , France

Hopital Nord

Saint-Priest-en-Jarez, , France

Hôpital Larrey

Toulouse, , France

Hôpital de Brabois / Bâtiment Philippe Canton

Vandœuvre-lès-Nancy, , France

Charite - Universitaetsmedizin Berlin

Berlin, , Germany

Hautarztpraxis

Berlin, , Germany

Dres.Kirsten Prepeneit und Volker Streit

Buchholz, , Germany

Universitaets- Hautklinik Koeln

Cologne, , Germany

Universitaetsklinik Carl Gustav Carus

Dresden, , Germany

Hautzentrum Duelmen

Dülmen, , Germany

Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

Erlangen, , Germany

Klinikum der Johann Wolfgang Goethe Universitaet

Frankfurt am Main, , Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Hautklinik der Ruprecht-Karls-Universitaet Heidelberg

Heidelberg, , Germany

Hautarztpraxis Dres. Scholz, Sebastian, Schilling

Mahlow, , Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

Mainz, , Germany

Technische Universitaet Muenchen

München, , Germany

Dres. med. Bredlich/PD Rosenbach/Thiele

Osnabrück, , Germany

Eberhard-Karls-Universitaet Tuebingen

Tübingen, , Germany

Hautarztpraxis

Witten, , Germany

The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

Hong Kong, , Hong Kong

Synexus Magyarorszag Kft.

Budapest, , Hungary

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum/Bor- es Nemikortani Klinika

Debrecen, , Hungary

Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat

Miskolc, , Hungary

SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

Szeged, , Hungary

ALLERGO-DERM BAKOS Kft.

Szolnok, , Hungary

Dermatology Department

Afula, , Israel

Academic Medical Centre (AMC)

Amsterdam, North Holland, Netherlands

PT & R

Beek, , Netherlands

Amphia Hospital Location Molengracht / Department Dermatology

Breda, , Netherlands

Erasmus MC

Rotterdam, , Netherlands

NZOZ Osteo-Medic s.c. Artur Racewicz, Jerzy Supronik

Bialystok, , Poland

Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne

Gdansk, , Poland

Krakowskie Centrum Medyczne NZOZ

Krakow, , Poland

Novum Instytut Dermatologii Leczniczej i Estetycznej

Opole, , Poland

Solumed S.C.

Poznan, , Poland

Korolev Dermatovenerologic Dispensary

Korolyov, Moscow Oblast, Russia

State Research Center of Dermatovenerology, Department of clinical dermatology

Moscow, , Russia

State Research Center of Dermatovenerology, Department of dermatology

Moscow, , Russia

Dermatovenerologic dispensary #7

Moscow, , Russia

Rostov-on-Don regional dermatovenerologic dispensary

Rostov-on-Don, , Russia

Ryazan regional clinical dermatovenerologic dispensary

Ryazan, , Russia

Dermatovenerologic dispensary #10 of Vyborg region

Saint Petersburg, , Russia

Military medical academy S.M. Kirov

Saint Petersburg, , Russia

North-Western State Medical University I.I. Mechnikov, Dermatovenerology Department

Saint Petersburg, , Russia

Clinic of dermatovenerologic diseases

Saratov, , Russia

Smolensk State Medical Academy

Smolensk, , Russia

Clinical hospital of emergency care N.V. Soloviev

Yaroslavl, , Russia

National Skin Centre

Singapore, , Singapore

Changi General Hospital

Singapore, , Singapore

Dermatologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta

Banská Bystrica, , Slovakia

Narodny ustav reumatickych chorob

Piešťany, , Slovakia

DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o.

Svidník, , Slovakia

Samsung Medical Center / Department of Dermatology

Gangnam-Gu, Seoul, South Korea

Severance Hospital, Yonsei University College of Medicine/Department of Dermatology

Seoul, , South Korea

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Hospital Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Universitario de La Princesa

Madrid, , Spain

Hospital 12 de Octubre

Madrid, , Spain

Consorcio Hospital General Universitario de Valencia

Valencia, , Spain

Falu lasarett, Hudkliniken

Falun, , Sweden

Hermelinen Forskning AB

Luleå, , Sweden

Skanes Universitetssjukhus i Malmo, Hudkliniken

Malmo, , Sweden

Sodersjukhuset, Hudkliniken

Stockholm, , Sweden

Karolinska Universitetssjukhuset Solna

Stockholm, , Sweden

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Gazi University Medical Faculty

Beşevler, Ankara, Turkey (Türkiye)

Istanbul university Istanbul Medical Faculty

Çapa, Istanbul, Turkey (Türkiye)

T.C. Saglik Bakanligi Marmara Universitesi Egitim ve Arastirma Hastanesi Dermatoloji Anabilim Dali

Pendik, Istanbul, Turkey (Türkiye)

Mersin University Medical Faculty

Akdeniz, Mersin, Turkey (Türkiye)

Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

Izmir, , Turkey (Türkiye)

Whipps Cross University Hospital

London, Leytonstone, United Kingdom

Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology

Leicester, , United Kingdom

Countries

Italy; Argentina; Austria; Belgium; Bosnia and Herzegovina; Bulgaria; Chile; Colombia; Croatia; Czechia; Denmark; France; Germany; Hong Kong; Hungary; Israel; Netherlands; Poland; Russia; Singapore; Slovakia; South Korea; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

References

Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.

Reference Type: DERIVED

PMID: 32816215 (View on PubMed)

Valenzuela F, Paul C, Mallbris L, Tan H, Papacharalambous J, Valdez H, Mamolo C. Tofacitinib versus etanercept or placebo in patients with moderate to severe chronic plaque psoriasis: patient-reported outcomes from a Phase 3 study. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1753-1759. doi: 10.1111/jdv.13702. Epub 2016 Jun 7.

Reference Type: DERIVED

PMID: 27271195 (View on PubMed)

Bachelez H, van de Kerkhof PC, Strohal R, Kubanov A, Valenzuela F, Lee JH, Yakusevich V, Chimenti S, Papacharalambous J, Proulx J, Gupta P, Tan H, Tawadrous M, Valdez H, Wolk R; OPT Compare Investigators. Tofacitinib versus etanercept or placebo in moderate-to-severe chronic plaque psoriasis: a phase 3 randomised non-inferiority trial. Lancet. 2015 Aug 8;386(9993):552-61. doi: 10.1016/S0140-6736(14)62113-9. Epub 2015 Jun 4.

Reference Type: DERIVED

PMID: 26051365 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921080&StudyName=A%20Phase%203%2C%20Multi%20Site%2C%20Randomized%2C%20Double%20Blind%2C%20Placebo%20Controlled%20Study%20Of%20The%20Efficacy%20And%20Safety%20Comparing%20CP-%20690%2C550%20And

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Other Identifiers

A3921080

Identifier Type: -

Identifier Source: org_study_id