A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

NCT ID: NCT01186744

Last Updated: 2018-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-01-31

Brief Summary

The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and subsequent withdrawal of active treatment at various timepoints during the 16 week double blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP 690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Conditions

Psoriasis

Keywords

OPT Retreatment; OPT; chronic; moderate; severe; treatment; safety; treatment withdrawal; retreatment; retreatment withdrawal; CP-690,550; Psoriasis Vulgaris; Plaque Psoriasis; tofacitinib; Xeljanz; nail psoriasis; Jak-inhibitor; oral treatment; Pruritus; Itch; DLQI; rebound; intermittent; retreat

Study Design

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

Study Groups

Active Treatment (10 mg) BID / Placebo BID

Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks

Group Type: EXPERIMENTAL

CP-690,550

Intervention Type: DRUG

10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design

Active Treatment (10 mg) BID

Continuous active treatment (CP-690,550) for 56 weeks

Group Type: EXPERIMENTAL

CP-690,550

Intervention Type: DRUG

10 mg oral BID

Active Treatment (5 mg) BID / Placebo BID

Continuous active treatment (CP-690,550) for 24 weeks, followed by treatment withdrawal (placebo treatment) for 4-16 weeks, followed by active treatment (CP-690,550) for 16-28 weeks

Group Type: EXPERIMENTAL

CP-690,550

Intervention Type: DRUG

5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design

Active Treatment (5 mg) BID

Continuous active treatment (CP-690,550) for 56 weeks

Group Type: EXPERIMENTAL

CP-690,550

Intervention Type: DRUG

5 mg oral BID

Interventions

CP-690,550

10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design

Intervention Type: DRUG

CP-690,550

10 mg oral BID

Intervention Type: DRUG

CP-690,550

5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design

Intervention Type: DRUG

CP-690,550

5 mg oral BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at least 12 months prior to first dose of study drug;
• Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at least 10% of body surface area;
• No evidence of active or latent or inadequately treated infection with Tuberculosis or other serious infections.

Exclusion Criteria

• Non-plaque or drug induced forms of psoriasis;
• Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).
• 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

Horizon Research Group, Inc.

Mobile, Alabama, United States

Radiant Research, Inc.

Tucson, Arizona, United States

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Associates In Research, Inc.

Fresno, California, United States

Dermatology Research Associates

Los Angeles, California, United States

Expresscare Medical

Los Angeles, California, United States

Dermatology Specialists, Inc.

Oceanside, California, United States

University of California San Francisco

San Francisco, California, United States

Longmont Clinic, PC

Longmont, Colorado, United States

New England Research Associates, LLC

Trumbull, Connecticut, United States

Florida Academic Dermatology Center

Miami, Florida, United States

International Dermatology Research, Inc.

Miami, Florida, United States

Park Avenue Dermatology, PA

Orange Park, Florida, United States

Ameriderm Research

Ormond Beach, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Altman Dermatology Associates

Arlington Heights, Illinois, United States

Springfield Clinic, LLP

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Deaconess Clinic Downtown

Evansville, Indiana, United States

DMIA

Louisville, Kentucky, United States

DermResearch, PLLC

Louisville, Kentucky, United States

Quest Diagnostics

Louisville, Kentucky, United States

Northeast Dermatology Associates

Beverly, Massachusetts, United States

ActivMed Practices and Research, Inc.

Haverhill, Massachusetts, United States

Michigan Center for Research Corporation dba Michigan Center for Skin Care Research

Clinton Township, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Comprehensive Clinical Research

Berlin, New Jersey, United States

Duke University Medical Center

Durham, North Carolina, United States

Dermatology Consulting Services

High Point, North Carolina, United States

Dermatology Associates

Wilmington, North Carolina, United States

New Hanover Medical Group, PA

Wilmington, North Carolina, United States

New Hanover Medical Research

Wilmington, North Carolina, United States

PMG Research of Wilmington LLC

Wilmington, North Carolina, United States

Piedmont Imaging

Winston-Salem, North Carolina, United States

Piedmont Medical Research

Winston-Salem, North Carolina, United States

Triad Dermatology, PA

Winston-Salem, North Carolina, United States

Jewish Hospital

Cincinnati, Ohio, United States

Radiant Research, Inc.

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Oregon Medical Research Center, PC

Portland, Oregon, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical Research South, LLC

Charleston, South Carolina, United States

Office of Marta T. Hampton, MD

Charleston, South Carolina, United States

Dermatology & Laser Center of Charleston

Charleston, South Carolina, United States

Office of John Michael Humeniuk, MD

Greer, South Carolina, United States

Radiant Research, Inc.

Greer, South Carolina, United States

Dermatology Research Associates

Nashville, Tennessee, United States

Office of Stephen Miller, MD, PA

San Antonio, Texas, United States

Center for Clinical Studies

Webster, Texas, United States

Mountain State Clinical Research

Clarksburg, West Virginia, United States

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

Dr. Glenn & Partners

Kogarah, New South Wales, Australia

Premier Dermatology

Kogarah, New South Wales, Australia

Skin and Cancer Foundation

Carlton, Victoria, Australia

Uniradiology

Carlton, Victoria, Australia

Malvern Diagnostic Imaging

Malvern, Victoria, Australia

Emeritus Research

Malvern East, Victoria, Australia

Instituto de Dermatologia e Est�ca do Brasil LTDA - IDERJ

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

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

Derm Research @ 888 Inc.

Vancouver, British Columbia, Canada

UBC Department of Dermatology and Skin Science

Vancouver, British Columbia, Canada

Nexus Clinical Research

St. John's, Newfoundland and Labrador, Canada

NewLab Clinical Research Inc.

St. John's, Newfoundland and Labrador, Canada

Dermatrials Research

Hamilton, Ontario, Canada

Windsor Clinical Research

Windsor, Ontario, Canada

Innovaderm Research Inc

Montreal, Quebec, Canada

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, Quebec, Canada

Department of Dermatology, Aarhus University Hospital

Aarhus C, , Denmark

Gentofte Hospital

Hellerup, , Denmark

Hudklinikken

Svendborg, , Denmark

Tampere University Hospital, Department of Dermatology and Venreology

Tampere, , Finland

Dermatology Department, Andreas Sygros Hospital

Aathens, , Greece

University Hospital of Ioannina/Dermatology Department

Ioannina, , Greece

"Papageorgiou" General Hospital / B' Dermatology and Venereology Clinic of University of Thessalonik

Thessaloniki, , Greece

PT & R

Beek, , Netherlands

Univerzitna Nemocnica, Bratislava

Bratislava, , Slovakia

Fakultna Nemocnica Trnava

Trnava, , Slovakia

Whipps Cross University Hospital, Department of Dermatology

London, Leytonstone, United Kingdom

Department of Dermatology

Nuneaton, Warwickshire, United Kingdom

Salford Royal NHS Foundation Trust

Manchester, , United Kingdom

Countries

United States; Argentina; Australia; Brazil; Bulgaria; Canada; Denmark; Finland; Greece; Netherlands; Slovakia; 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)

Bissonnette R, Iversen L, Sofen H, Griffiths CE, Foley P, Romiti R, Bachinsky M, Rottinghaus ST, Tan H, Proulx J, Valdez H, Gupta P, Mallbris L, Wolk R. Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial. Br J Dermatol. 2015;172(5):1395-406. doi: 10.1111/bjd.13551. Epub 2015 Apr 2.

Reference Type: DERIVED

PMID: 25418186 (View on PubMed)

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921111&StudyName=A%20Phase%203%2C%20Multi-Site%2C%20Randomized%2C%20Mixed-Blind%2C%20Parallel-Group%20Treatment%20Withdrawal%20And%20Re-Treatment%20Study%20Of%20The%20Efficacy%20And%20Safety%20Of%202%20Oral%20Doses%20Of%20CP-690%2C550%20In%20Subjects%20With%20Moderate%20To%20Severe%20Chronic%20Plaque%20Psoriasis

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Other Identifiers

A3921111

Identifier Type: -

Identifier Source: org_study_id