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

NCT01519089 | Completed Phase 3 Results DMC

• 1 other identifier: A3921137
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 16

Brief Summary

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.

Conditions

Psoriasis

Keywords

chronic; severe; moderate; treatment; safety; efficacy; CP-690; 550; Plaque psoriasis; Psoriasis Vulgaris; Psoriatic Arthritis; tofacitinib; Xeljanz

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16

  The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.

  Week 16

• Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16

  The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).

  Week 16

• Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16

  ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

  Week 16

• Number of Participants With Adjudicated Cardiovacular Events

  Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.

  Baseline to Follow-up

• Number of Participants With Malignancy Events _Week 0 Through Follow-up

  For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.

  Baseline to Follow-up

Secondary Outcomes (33)

• Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response

  Week 2, 4, 8, 12, 20, 28, 40, 52

• Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response

  Week 2, 4, 8, 12, 16, 20, 28, 40, 52

• Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response

  Week 2, 4, 8, 12, 16, 20, 28, 40, 52

• Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'

  Week 16

• Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response

  Week 16

Study Arms (2)

CP-690,550 10 mg BID

EXPERIMENTAL

Drug: CP-690,550

CP690,550 5 mg BID

EXPERIMENTAL

Drug: CP-690, 550

Interventions

CP-690,550 DRUG

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.

CP-690,550 10 mg BID

CP-690, 550 DRUG

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.

CP690,550 5 mg BID

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (16)

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

JR Sapporo hospital

Sapporo, Hokkaido, 060-0033, Japan

Location

Kobe University Hospital

Chuo-ku, Kobe, Hyōgo, 650-0017, Japan

Location

Kanazawa Medical University Hospital

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

Location

National Hospital Organization Sagamihara National Hospital

Sagamihara, Kanagawa, 252-0392, Japan

Location

University of Miyazaki Hospital

Miyazaki, Miyazaki, 889-1692, Japan

Location

Nissay Hospital

Osaka, Osaka, 550-0012, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 324-0498, Japan

Location

Tokyo Teishin Hospital

Chiyoda-ku, Tokyo, 102-8798, Japan

Location

Tokyo medical university Hachioji medical center

Hachiōji, Tokyo, 193-0998, Japan

Location

Kanto Medical Center NTT East Corporation

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Tokyo Medical University Hospital

Shinjyuku-ku, Tokyo, 160-0023, Japan

Location

Tonami General Hospital

Tonami, Toyama, 939-1395, Japan

Location

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan

Location

Jikei University Hospital

Tokyo, 105-8471, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Psoriasis; Bronchiolitis Obliterans Syndrome; Lymphoma, Follicular; Arthritis, Psoriatic

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 26, 2012
• Study Start: March 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 13, 2015
• Results First Posted: August 13, 2015

Record last verified: 2015-08

Locations

JP (16)