Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

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NCT01877668

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Study Location
Rheumatology Associates, PC
Birmingham, Alabama, 35205, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

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1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males or females, aged >= 18 years at time of consent.

- Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months

- Meet the Classification Criteria of PsA (CASPAR) at time of screening

- Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).

- Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required

- Must not have taken a biologic Tumour Necrosis Factor Inhibitor

- Must have 3 or more swollen joints AND 3 or more tender joints

- Must have active psoriasis skin lesions

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the
exception of nail psoriasis which is allowed


- Pregnant or breast feeding, females of child-bearing potential not using highly
effective contraception


- New York Heart Association Class III and IV congestive heart failure


- History of hypersensitivity or infusion reaction to biologic agents


- Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
Official Title  ICMJE A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis
Brief Summary This is a 12-month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms of active psoriatic arthritis and improving physical function and preserving bone structure in patients with an inadequate response to a traditional, nonbiologic disease-modifying antirheumatic drug. Adalimumab is used as a comparator.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • Drug: Tofacitinib 5 mg BID
    Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
  • Drug: Tofacitinib 10 mg BID
    Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
  • Drug: Adalimumab
    Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
  • Drug: Placebo
    Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
  • Drug: Placebo
    Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months
Study Arms  ICMJE
  • Experimental: Tofacitinib 5 mgBID x 12 months
    Intervention: Drug: Tofacitinib 5 mg BID
  • Experimental: Tofacitinib 10 mg BID x 12 months
    Intervention: Drug: Tofacitinib 10 mg BID
  • Active Comparator: Adalimumab 40 mg q2 weeks x 12 months
    Intervention: Drug: Adalimumab
  • Placebo Comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2016)		422
Original Estimated Enrollment  ICMJE
 (submitted: June 12, 2013)		400
Actual Study Completion Date  ICMJE December 18, 2015
Actual Primary Completion Date December 18, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females, aged >= 18 years at time of consent.
  • Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
  • Meet the Classification Criteria of PsA (CASPAR) at time of screening
  • Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
  • Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
  • Must not have taken a biologic Tumour Necrosis Factor Inhibitor
  • Must have 3 or more swollen joints AND 3 or more tender joints
  • Must have active psoriasis skin lesions

Exclusion Criteria:

  • Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
  • Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
  • New York Heart Association Class III and IV congestive heart failure
  • History of hypersensitivity or infusion reaction to biologic agents
  • Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Bulgaria,   Canada,   Czechia,   France,   Germany,   Hungary,   Mexico,   Poland,   Russian Federation,   Slovakia,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01877668
Other Study ID Numbers  ICMJE A3921091
2011-003668-55 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:

Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

http://www.pfizer.com/research/clinical_trials/trial_data_and_results/d…

Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP