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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01163253
First received: July 14, 2010
Last updated: May 18, 2016
Last verified: May 2016
  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
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:


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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ 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 June 2016 ] [ Designated as safety issue: No ]
  • Patient Global Assessment (PtGA) [ Time Frame: Month 1, month 3, and every three months thereafter until approximately June 2016 ] [ Designated as safety issue: No ]
  • Euro-Qol 5 Dimensions (EQ-5D) [ Time Frame: Month 6, and then every 6 months thereafter until approximately June 2016 ] [ Designated as safety issue: No ]
  • Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) [ Time Frame: Month 6, and then every 6 months thereafter until approximately June 2016 ] [ Designated as safety issue: No ]

Enrollment: 2925
Study Start Date: September 2010
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (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

Detailed Description:
The study terminated on 08MAR2016 as it met its objectives of characterizing long term safety and tolerability. The study did not terminate due to safety concerns.
  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
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: NCT01163253

  Show 325 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01163253     History of Changes
Other Study ID Numbers: A3921061  2010-020002-15 
Study First Received: July 14, 2010
Last Updated: May 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
chronic
severe
treatment
safety
CP-690,550
Plaque Psoriasis
Psoriasis Vulgaris
Xeljanz
Tofacitinib

Additional relevant MeSH terms:
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016