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

NCT01241591 | Completed Phase 3 Results DMC

• 1 other identifier: A3921080
• Study Type: interventional
• Target: 1,101
• Locations: 26 countries
• Sites: 122

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12

  The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 to 4). The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

  Week 12

• Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 12

  The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to baseline/Day 1.

  Week 12

Secondary Outcomes (44)

• Percentage of Participants With a PGA Response of "Clear" or "Almost Clear" During the 12-Week Double-Blind Treatment

  Weeks 2, 4, and 8

• Percentage of Participants in Each PGA Category During the 12-Week Double-Blind Treatment

  Baseline and Weeks 2, 4, 8, and 12

• Percentage of Participants With a PASI75 Response During the 12-Week Double-Blind Treatment

  Weeks 2, 4, and 8

• Mean PASI Score During the 12-Week Double-Blind Treatment

  Baseline and Weeks 2, 4, 8, and 12

• Mean Change From Baseline in PASI Score During the 12-Week Double-Blind Treatment

  Weeks 2, 4, 8, and 12

Study Arms (4)

CP 690,550 5 mg BID+Placebo BIW

EXPERIMENTAL

Drug: CP 690,550 5 mg

CP 690,550 10 mg BID+Placebo BIW

EXPERIMENTAL

Drug: CP 690,550 10 mg

Placebo BID+Etanercept 50 mg BIW

ACTIVE COMPARATOR

Biological: Etanercept 50 mg

Placebo BID+Placebo BIW

PLACEBO COMPARATOR

Other: Placebo

Interventions

CP 690,550 5 mg DRUG

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

CP 690,550 5 mg BID+Placebo BIW

CP 690,550 10 mg DRUG

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

CP 690,550 10 mg BID+Placebo BIW

Etanercept 50 mg BIOLOGICAL

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

Placebo BID+Etanercept 50 mg BIW

Placebo OTHER

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

Placebo BID+Placebo BIW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (122)

Centro de Investigaciones Dermatologicas

Buenos Aires, C1114aap, Argentina

Location

Centro de Investigaciones Dermatologicas

Buenos Aires, C1114AAP, Argentina

Location

IMAI (Instituto Medico de Asistencia e Investigaciones)

Buenos Aires, C1425AWC, Argentina

Location

LKH Feldkirch Abteilung fuer Dermatologie und Venerologie

Feldkirch, A-6807, Austria

Location

LKH Innsbruck Universitaetsklinik fuer Dermatologie und Venerologie

Innsbruck, A-6020, Austria

Location

LKH Salzburg, Landesklinik fuer Dermatologie

Salzburg, 5020, Austria

Location

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhuegel

Vienna, 1130, Austria

Location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

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

Sarajevo, 71000, Bosnia and Herzegovina

Location

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

Pleven, 5800, Bulgaria

Location

Tsentar za kozhno-venericheski zaboliavania" EOOD

Sofia, 1404, Bulgaria

Location

Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa Sofia- Sofia

Sofia, 1407, Bulgaria

Location

Universitetska mnogoprofilna bolnitsa za aktivno lechenie- Alexandrovska- Sofia

Sofia, 1431, Bulgaria

Location

MBAL na Voennomeditsinska akademia- Sofia

Sofia, 1606, Bulgaria

Location

Centro de Especialidades Dermatologicas

Viña del Mar, Región de Valparaíso, 00000, Chile

Location

Clinica Davila

Santiago, Rm 8431657, RM, 8420383, Chile

Location

Clinica Dermovein S.A.

Santiago, 7640881, Chile

Location

Hospital Clinico Universidad de Chile, Departamento Dermatologia

Santiago, 8380456, Chile

Location

Reumalab S.A.S.

Medellín, Antioquia, 0, Colombia

Location

Centro Integral de Reumatología del Caribe Circaribe S.A

Barranquilla, Atlántico, 0000, Colombia

Location

Centro de Investigacion Clinica de la Universidad del Rosario

Bogota, Cundinamarca, 0000, Colombia

Location

Riesgo de Fractura S.A.

Bogota, Cundinamarca, 0000, Colombia

Location

Medicity S.A.S

Bucaramanga, Santander Department, 0000, Colombia

Location

Department of Dermatovenerology, University Hospital Center Osijek

Osijek, 31000, Croatia

Location

Dermatovenerological Clinic, University hospital center "Sestre milosrdnice"

Zagreb, 10 000, Croatia

Location

Department of dermatovenerology, University Hospital Center Zagreb

Zagreb, 10000, Croatia

Location

Nemocnice Ceske Budejovice, a.s.

České Budějovice, 37001, Czechia

Location

FN Kradec Kralove

Hradec Králové, 50005, Czechia

Location

Fakultni nemocnice Plzen

Plzen - Bory, 30599, Czechia

Location

Kozni ordinace

Prague, 11000, Czechia

Location

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

Ústí nad Labem, 40113, Czechia

Location

Kralska zdravotni

Ústí nad Labem, 40113, Czechia

Location

Department of Dermatology, Aarhus University Hospital

Aarhus C, 8000, Denmark

Location

Bispebjerg Hospital, University of Copenhagen

Copenhagen NV, 2400, Denmark

Location

Hudklinikken Herning

Herning, 7400, Denmark

Location

CHG Le Mans

Le Mans, Cedex 09, 72037, France

Location

CHU de Besancon - Hopital Saint Jacques

Besançon, 25030, France

Location

Hopital Ambroise Pare, Service de Dermatologie

Boulogne, 92104, France

Location

Chu Morvan

Brest Cédex, 29609, France

Location

Hopital Dupuytren

Limoges, 87042, France

Location

Hopital Fournier

Nancy Cédex, 54035, France

Location

CHU de Nantes - Hotel Dieu

Nantes, 44035, France

Location

CHU de NICE - Hôpital de l'Archet II

Nice, 06200, France

Location

Hopital Saint-Louis

Paris, 75010, France

Location

Hôpital Bichat

Paris, 75018, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

C.H.U. de Poitiers

Poitiers, 86000, France

Location

Hopital Robert Debre

Reims, 51100, France

Location

Hopital Nord

Saint-Priest-en-Jarez, 42270, France

Location

Hôpital Larrey

Toulouse, 31059, France

Location

Hôpital de Brabois / Bâtiment Philippe Canton

Vandœuvre-lès-Nancy, 54511, France

Location

Charite - Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Hautarztpraxis

Berlin, 13507, Germany

Location

Dres.Kirsten Prepeneit und Volker Streit

Buchholz, 21244, Germany

Location

Universitaets- Hautklinik Koeln

Cologne, 50924, Germany

Location

Universitaetsklinik Carl Gustav Carus

Dresden, 01307, Germany

Location

Hautzentrum Duelmen

Dülmen, 48249, Germany

Location

Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum

Erlangen, 91054, Germany

Location

Klinikum der Johann Wolfgang Goethe Universitaet

Frankfurt am Main, 60590, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Hautklinik der Ruprecht-Karls-Universitaet Heidelberg

Heidelberg, 69115, Germany

Location

Hautarztpraxis Dres. Scholz, Sebastian, Schilling

Mahlow, 15831, Germany

Location

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR

Mainz, 55131, Germany

Location

Technische Universitaet Muenchen

München, 80802, Germany

Location

Dres. med. Bredlich/PD Rosenbach/Thiele

Osnabrück, 49078, Germany

Location

Eberhard-Karls-Universitaet Tuebingen

Tübingen, 72076, Germany

Location

Hautarztpraxis

Witten, 58453, Germany

Location

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

Hong Kong, 0, Hong Kong

Location

Synexus Magyarorszag Kft.

Budapest, 1036, Hungary

Location

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

Debrecen, 4032, Hungary

Location

Miskolci Semmelweis Ignac Korhaz-Rendelointezet/Borgyogyaszat

Miskolc, 3529, Hungary

Location

SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika

Szeged, 6720, Hungary

Location

ALLERGO-DERM BAKOS Kft.

Szolnok, 5000, Hungary

Location

Dermatology Department

Afula, 18101, Israel

Location

Academic Medical Centre (AMC)

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

PT & R

Beek, 6191 JW, Netherlands

Location

Amphia Hospital Location Molengracht / Department Dermatology

Breda, 4800 RK, Netherlands

Location

Erasmus MC

Rotterdam, 3015 CA, Netherlands

Location

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

Bialystok, 05-354, Poland

Location

Klinika Dermatologii, Wenerologii i Alergologii, Uniwersyteckie Centrum Kliniczne

Gdansk, 80-952, Poland

Location

Krakowskie Centrum Medyczne NZOZ

Krakow, 31-501, Poland

Location

Novum Instytut Dermatologii Leczniczej i Estetycznej

Opole, 45-080, Poland

Location

Solumed S.C.

Poznan, 60-539, Poland

Location

Korolev Dermatovenerologic Dispensary

Korolyov, Moscow Oblast, 141070, Russia

Location

State Research Center of Dermatovenerology, Department of clinical dermatology

Moscow, 107076, Russia

Location

State Research Center of Dermatovenerology, Department of dermatology

Moscow, 107076, Russia

Location

Dermatovenerologic dispensary #7

Moscow, 121614, Russia

Location

Rostov-on-Don regional dermatovenerologic dispensary

Rostov-on-Don, 344007, Russia

Location

Ryazan regional clinical dermatovenerologic dispensary

Ryazan, 390046, Russia

Location

Dermatovenerologic dispensary #10 of Vyborg region

Saint Petersburg, 194021, Russia

Location

Military medical academy S.M. Kirov

Saint Petersburg, 194044, Russia

Location

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

Saint Petersburg, 195067, Russia

Location

Clinic of dermatovenerologic diseases

Saratov, 410028, Russia

Location

Smolensk State Medical Academy

Smolensk, 214019, Russia

Location

Clinical hospital of emergency care N.V. Soloviev

Yaroslavl, 150003, Russia

Location

National Skin Centre

Singapore, 308205, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

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

Banská Bystrica, 975 17, Slovakia

Location

Narodny ustav reumatickych chorob

Piešťany, 921 12, Slovakia

Location

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

Svidník, 089 01, Slovakia

Location

Samsung Medical Center / Department of Dermatology

Gangnam-Gu, Seoul, 135-710, South Korea

Location

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

Seoul, 120-752, South Korea

Location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Hospital Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Falu lasarett, Hudkliniken

Falun, 791 82, Sweden

Location

Hermelinen Forskning AB

Luleå, 972 33, Sweden

Location

Skanes Universitetssjukhus i Malmo, Hudkliniken

Malmo, 205 02, Sweden

Location

Sodersjukhuset, Hudkliniken

Stockholm, 118 83, Sweden

Location

Karolinska Universitetssjukhuset Solna

Stockholm, 171 76, Sweden

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Gazi University Medical Faculty

Beşevler, Ankara, 06500, Turkey (Türkiye)

Location

Istanbul university Istanbul Medical Faculty

Çapa, Istanbul, 34390, Turkey (Türkiye)

Location

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

Pendik, Istanbul, 34890, Turkey (Türkiye)

Location

Mersin University Medical Faculty

Akdeniz, Mersin, 33070, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Tip Fakultesi Dermatoloji Anabilim Dali

Izmir, 35340, Turkey (Türkiye)

Location

Whipps Cross University Hospital

London, Leytonstone, E11 1NR, United Kingdom

Location

Leicester Royal Infirmary, Balmoral building, Clinic 3, Dermatology

Leicester, LE1 5WW, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 32816215 DERIVED

• 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.

  PMID: 27271195 DERIVED

• 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.

  PMID: 26051365 DERIVED

Related Links

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

MeSH Terms

Conditions

Psoriasis; Lymphoma, Follicular; Bronchiolitis Obliterans Syndrome; Plaque, Amyloid; Pruritus

Interventions

tofacitinib; Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Limitations and Caveats

Clinical interpretation regarding sub-phenotypes of psoriasis (e.g., scalp psoriasis) should not be made based on the reported assessments by body regions. For example, the body region of head does not reflect solely scalp psoriasis.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2010
• First Posted: November 16, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 26, 2018
• Results First Posted: May 7, 2014

Record last verified: 2018-12

Locations

HK (1); AR (3); KR (2); NL (4); AU (4); CL (4); CZ (6); CR (3); SG (2); ES (6); CO (5); DE (16); SE (5); PL (5); DK (3); BU (5); RU (12); TU (5); GB (2); FR (16); CH (1); BE (2); BO (1); HU (5); IL (1); SL (3)