A Long Term Study To Evaluate The Safety And Tolerability Of CP-690,550 For Patients With Moderate To Severe Chronic Plaque Psoriasis - Full Text View

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 chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.

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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence and severity of adverse events during treatment. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: Yes ]
Incidence of clinical laboratory abnormalities and change from baseline (in this and/or prior study) in clinical laboratory values during treatment. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: Yes ]
Incidence of investigator-reported clinically significant changes in physical examination from baseline (in this and/or prior study) during treatment. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: Yes ]
Incidence of vital sign (blood pressure and heart rate) abnormalities and change from baseline (in this and/or prior study) in vital sign measures during treatment. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: Yes ]
Summary of adjudicated cardiovascular endpoints. Summary of malignancies confirmed by central laboratory pathologist over read of biopsies. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: Yes ]
Incidence of electrocardiogram (ECG) abnormalities and change from baseline (in this and/or prior study) in ECG measurements during treatment. [ Time Frame: Month 6, and every 6 months thereafter until approxinmately April, 2017 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Physician's Global Assessment (PGA) response ie, the proportion of participants achieving a PGA of "clear" or "almost clear" at various time points. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: No ]
Psoriasis Area and Severity Index 75 (PASI75) response ie, the proportion of participants achieving at least a 75% reduction in PASI relative to baseline (in this and/or prior study) at various time points. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: No ]
Actual and change from baseline (in this and/or prior study) in PASI and PASI component scores at various time points. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: No ]
Proportion of participants achieving at least a 50% and 90% reduction in PASI relative to baseline (in this and/or prior study) (ie, PASI50 and PASI90, respectively) at various time points. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: No ]
Proportion of participants with a PASI score >= 125% of the baseline PASI score (in this and/or prior study) at any time point. [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: No ]
Actual and change from baseline (in this and/or prior study) in the Itch Severity Item (ISI) score [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: No ]
Actual and change from baseline (in this and/or prior study) on the Dermatology Life Quality Index (DLQI) score. [ Time Frame: Month 1, Month 6, and every six months thereafter until approximately April, 2017 ] [ Designated as safety issue: No ]
Short Form-36 Health Survey (SF-36) - (Version 2, Acute) [ Time Frame: Month 6, and then every 6 months thereafter until approximately April, 2017 ] [ Designated as safety issue: No ]
Patient Global Assessment (PtGA) [ Time Frame: Month 1, month 3, and every three months thereafter until approximately April 2017 ] [ Designated as safety issue: No ]
Euro-Qol 5 Dimensions (EQ-5D) [ Time Frame: Month 6, and then every 6 months thereafter until approximately April, 2017 ] [ Designated as safety issue: No ]
Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) [ Time Frame: Month 6, and then every 6 months thereafter until approximately April, 2017 ] [ Designated as safety issue: No ]

Estimated Enrollment:	3200
Study Start Date:	September 2010
Estimated Study Completion Date:	April 2017
Estimated Primary Completion Date:	April 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Active Treatment The study is anticipated to continue for up to at least 2 years post First Market Approval (FMA) in a global, major market. All subjects will receive 10 mg BID of CP-690,550 for first 3 months of trial. Study has the option for variable dosing with 5 mg or 10 mg BID after first 3-months of treatment based on PI discretion	Drug: CP-690,550 5 mg oral BID Drug: CP-690,550 10 mg oral BID

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have participated in qualifying study with CP-690,550 and are 18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris).

Exclusion Criteria:

Non-plaque or drug induced forms of psoriasis;
Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot discontinue phototherapy (PUVA or UVB).
Any uncontrolled significant medical condition.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163253

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 300 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01163253 History of Changes
Other Study ID Numbers:	A3921061
Study First Received:	July 14, 2010
Last Updated:	May 8, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

chronic
severe
treatment
safety

CP-690
550
Plaque Psoriasis
Psoriasis Vulgaris

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013