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A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
JR Sapporo hospital
Sapporo, Hokkaido, 060-0033 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Are 20 years or older and considered to be candidates for systemic or phototherapy.

[Moderate to Severe Plaque Psoriasis]

- Diagnosed for at least 12 months.

- Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis
covering at least 10% of body surface area (BSA).

[Psoriatic Arthritis]

- Diagnosed for at least 6 months.

- Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at
screening;

- Have active arthritis (≥3 tender/painful joints on motion and ≥3 swollen joints), and
active plaque psoriasis with at least 2 cm in diameter.

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

- Non-plaque or drug induced forms of psoriasis

- Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic
arthritis or cannot discontinue phototherapy (PUVA or UVB)

- any uncontrolled significant medical condition

NCT01519089
Pfizer
Completed
A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

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A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis
A Phase 3, Multi Site, Randomized, Double Blind Study Of The Long-term Safety, Tolerability And Efficacy Of 2 Oral Doses Of Cp 690,550 In Subjects With Moderate To Severe Plaque Psoriasis And/or Psoriatic Arthritis
The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriasis
  • Drug: CP-690,550
    10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
  • Drug: CP-690, 550
    5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
  • Experimental: CP-690,550 10 mg BID
    Intervention: Drug: CP-690,550
  • Experimental: CP690,550 5 mg BID
    Intervention: Drug: CP-690, 550
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
January 2014
January 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Are 20 years or older and considered to be candidates for systemic or phototherapy.

[Moderate to Severe Plaque Psoriasis]

  • Diagnosed for at least 12 months.
  • Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA).

[Psoriatic Arthritis]

  • Diagnosed for at least 6 months.
  • Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening;
  • Have active arthritis (?3 tender/painful joints on motion and ?3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter.

Exclusion Criteria:

  • Non-plaque or drug induced forms of psoriasis
  • Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB)
  • any uncontrolled significant medical condition
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01519089
A3921137
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2015

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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