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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01519089
First received: December 22, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Psoriasis
Drug: CP-690,550
Drug: CP-690, 550
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of adverse events, clinical laboratory abnormalities, vital sign abnormalities and electrocardiogram (ECG) abnormalities [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Change from baseline in clinical laboratory values, vital sign measures and ECG measurements. [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Number of subjects with pre-specified cardiovascular events [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Number of subjects with malignancies confirmed by central laboratory pathologist over-read [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with a Psoriasis Area and Severity Index 75 (PASI75) response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects With an American College of Rheumatology 20% (ACR20) Response at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with a Psoriasis Area and Severity Index 75 (PASI75) response [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with a Psoriasis Area and Severity Index 50 (PASI50) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with a Psoriasis Area and Severity Index 90 (PASI90) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Time to achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • Time to Achieve a PASI75 Response [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • Time to Achieve a PASI50 Response [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects with PASI score >= 125 percent of the baseline PASI scor [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index (PASI) scores [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Psoriasis Area and Severity Index (PASI) component scores [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with categorical responses in Physician Global Assessment (PGA) of psoriasis score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Number of subjects maintaining PASI75 response [ Time Frame: Week 16 up to Week 52 ] [ Designated as safety issue: No ]
  • Number of subjects maintaining PGA response [ Time Frame: Week 16 up to Week 52 ] [ Designated as safety issue: No ]
  • Nail Psoriasis Severity Index (NAPSI) [ Time Frame: Week 8, 16, 20, 28, 40 and 52 ] [ Designated as safety issue: No ]
  • Number of affected nails [ Time Frame: Week 8, 16, 20, 28, 40 and 52 ] [ Designated as safety issue: No ]
  • Itch Severity Item (ISI) score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Dermatology Life Quality Index (DLQI) score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 ] [ Designated as safety issue: No ]
  • 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Week 16, 28 and 52 ] [ Designated as safety issue: No ]
  • Work Limitation Questionnaire (WLQ) [ Time Frame: Week 4, 16, 28 and 52 ] [ Designated as safety issue: No ]
  • Patient Global Assessment (PtGA) of Psoriasis Score [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40 and 52 ] [ Designated as safety issue: No ]
  • Joint Pain Assessment (JPA) [ Time Frame: Week 4, 16, 28 and 52 ] [ Designated as safety issue: No ]
  • Proportion of subjects with an American College of Rheumatology 20% (ACR20) response [ Time Frame: Week 2, 4, 8, 12, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with an American College of Rheumatology 50% (ACR50) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of subjects with an American College of Rheumatology 70% (ACR70) response [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Change from baseline in American College of Rheumatology (ACR) components [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Week 2, 4, 8, 12, 16, 20, 28, 40, 52 and Follow-up 2 to 4 weeks after last dose ] [ Designated as safety issue: No ]

Enrollment: 95
Study Start Date: March 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP-690,550 10 mg BID 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.
Experimental: CP690,550 5 mg BID 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519089

Locations
Japan
JR Sapporo hospital
Sapporo, Hokkaido, Japan
Kobe University Hospital
Chuo-ku, Kobe, Hyogo, Japan
Kanazawa Medical University Hospital
Kahoku-gun, Ishikawa, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
University of Miyazaki Hospital
Miyazaki-shi, Miyazaki, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan
Tokyo Teishin Hospital
Chiyoda-ku, Tokyo, Japan
Tokyo medical university Hachioji medical center
Hachioji, Tokyo, Japan
Kanto Medical Center NTT East Corporation
Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjyuku-ku, Tokyo, Japan
Tonami General Hospital
Tonami, Toyama, Japan
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan
Fukuoka University Hospital
Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Nissay Hospital
Osaka, Japan
Jikei University Hospital
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01519089     History of Changes
Other Study ID Numbers: A3921137
Study First Received: December 22, 2011
Last Updated: February 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
chronic
severe
moderate
treatment
safety
efficacy
CP-690, 550
Plaque psoriasis
Psoriasis Vulgaris
Psoriatic Arthritis
tofacitinib
Xeljanz

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014