You are here

Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Rheumatology Associates P.C.
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

- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3
swollen joints

- Active plaque psoriasis at screening

- Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

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

- Non-plaque forms of psoriasis (with exception of nail psoriasis)

- History of autoimmune rheumatic disease other than PsA; also prior history of or
current, rheumatic inflammatory disease other than PsA

NCT01882439
Pfizer
Completed
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor
To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriatic Arthritis
  • Drug: Tofacitinib
    tablets, 5 mg BID x 6 months
  • Drug: Tofacitinib
    tablets, 10 mg BID x 6 months
  • Other: Placebo
    tablets, to match tofacitinib 5 mg BID x 3 months
  • Drug: Tofacitinib
    tablets, 5 mg BID x 3 months
  • Other: Placebo
    tablets, to match tofacitinib 10 mg BID x 3 months
  • Drug: Tofacitinib
    tablets, 10 mg BID x 3 months
  • Experimental: Treatment Sequence A
    Tofacitinib 5 mg BID for 6 months
    Intervention: Drug: Tofacitinib
  • Experimental: Treatment Sequence B
    Tofacitinib 10 mg BID for 6 months
    Intervention: Drug: Tofacitinib
  • Placebo Comparator: Treatment Sequence C
    Placebo for 3 months then tofacitinib 5 mg BID for 3 months
    Interventions:
    • Other: Placebo
    • Drug: Tofacitinib
  • Placebo Comparator: Treatment Sequence D
    Placebo for 3 months then tofacitinib 10 mg BID for 3 months
    Interventions:
    • Other: Placebo
    • Drug: Tofacitinib
Gladman D, Rigby W, Azevedo VF, Behrens F, Blanco R, Kaszuba A, Kudlacz E, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib for Psoriatic Arthritis in Patients with an Inadequate Response to TNF Inhibitors. N Engl J Med. 2017 Oct 19;377(16):1525-1536. doi: 10.1056/NEJMoa1615977.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
395
April 2016
April 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
  • Active plaque psoriasis at screening
  • Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

Exclusion Criteria:

  • Non-plaque forms of psoriasis (with exception of nail psoriasis)
  • History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
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,   Brazil,   Czechia,   France,   Germany,   Mexico,   Poland,   Russian Federation,   Slovakia,   Spain,   Taiwan,   United Kingdom,   United States
Canada,   Czech Republic
 
NCT01882439
A3921125
2013-001368-46 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now