A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis (PRIDE)

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00513370

First received: August 6, 2007

Last updated: April 7, 2011

Last verified: April 2011

History of Changes

Results First Received: August 21, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Psoriasis
Intervention:	Biological: Humira (adalimumab)

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Adalimumab 40 mg Eow	adalimumab 40 mg every other week (eow)

Participant Flow: Overall Study

	Adalimumab 40 mg Eow
STARTED	203
COMPLETED	179
NOT COMPLETED	24

Baseline Characteristics

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Reporting Groups

	Description
Adalimumab 40 mg Eow	adalimumab 40 mg every other week (eow)

Baseline Measures

	Adalimumab 40 mg Eow
Number of Participants [units: participants]	203
Age [units: participants]
<=18 years	0
Between 18 and 65 years	192
>=65 years	11
Age [units: years] Mean ± Standard Deviation	45.5 ± 12.34
Gender [units: participants]
Female	79
Male	124
Region of Enrollment [units: participants]
Canada	203

Outcome Measures

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1. Primary:

Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks [ Time Frame: 16 weeks ]

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2. Secondary:

Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks [ Time Frame: 16 and 24 weeks ]

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3. Secondary:

Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks [ Time Frame: 16 and 24 weeks ]

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4. Secondary:

Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA) [ Time Frame: 16 and 24 weeks ]

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5. Secondary:

Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of "Clear" or “Clear or Minimal” [ Time Frame: 16 and 24 weeks ]

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6. Secondary:

Mean Change From Baseline in Physician Global Assessment of Arthritic Disease Activity at 16 and 24 Weeks [ Time Frame: 16 and 24 weeks ]

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7. Secondary:

Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response [ Time Frame: 16 and 24 weeks ]

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8. Secondary:

Mean Change From Baseline in Tender Joint Count at 16 and 24 Weeks [ Time Frame: 16 and 24 weeks ]

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9. Secondary:

Mean Change From Baseline in Swollen Joint Count at 16 and 24 Weeks [ Time Frame: 16 and 24 weeks ]

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10. Secondary:

Mean Change From Baseline in Patient's Global Assessment of Joint Pain at 16 and 24 Weeks [ Time Frame: 16 and 24 weeks ]

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11. Secondary:

Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) at 16 and 24 Weeks [ Time Frame: 16 and 24 weeks ]

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12. Secondary:

Number of Subjects Achieving a Dermatology Life Quality Index (DLQI) = 0 [ Time Frame: 16 and 24 weeks ]

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13. Secondary:

Mean Change From Baseline in Beck Depression Inventory (BDI-II) at 16 and 24 Weeks [ Time Frame: 16 and 24 weeks ]

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14. Secondary:

Change From Baseline on the EuroQol (EQ-5D) Quality of Life Questionnaire [ Time Frame: 16 and 24 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

15. Secondary:

Change in Productivity Outcomes and Costs From Baseline as Measured by the Health and Labour Questionnaire (HLQ) [ Time Frame: 16 and 24 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

16. Secondary:

Change in Resource Utilization Outcomes and Costs From Baseline as Measured by the Health Care Resource (HCR) Questionnaire [ Time Frame: 16 and 24 weeks ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The first publication and presentation of this Study shall reside with Abbott. No independent manuscript may be submitted for publication until the first manuscript has been accepted for publication or twelve (12) months after completion of Study at all sites, which ever occurs first.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Medical Information Specialist
Organization: Abbott
phone: 1-800-633-9110

No publications provided

Responsible Party:	Isabel Pereira, Affiliate Project Manager, Abbott
ClinicalTrials.gov Identifier:	NCT00513370 History of Changes
Other Study ID Numbers:	W10-151
Study First Received:	August 6, 2007
Results First Received:	August 21, 2009
Last Updated:	April 7, 2011
Health Authority:	Canada: Health Canada

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