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Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Last updated on August 9, 2018

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

NCT01877668
Pfizer
Completed
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

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Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriatic Arthritis
  • 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
  • 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
Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cie?lak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
422
December 18, 2015
December 18, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Bulgaria,   Canada,   Czechia,   France,   Germany,   Hungary,   Mexico,   Poland,   Russian Federation,   Slovakia,   Spain,   Taiwan,   United Kingdom,   United States
Czech Republic
 
NCT01877668
A3921091
2011-003668-55 ( EudraCT Number )
Yes
Not Provided
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/da...

Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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