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| Study Type: | Interventional |
|---|---|
| Study Design: | Non-Randomized, Open Label, Single Group Assignment |
| Condition: |
Psoriasis |
| Intervention: |
Biological: Humira (adalimumab) |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| Description | |
|---|---|
| Adalimumab 40 mg Eow | adalimumab 40 mg every other week (eow) |
| Adalimumab 40 mg Eow | |
|---|---|
| STARTED | 203 |
| COMPLETED | 179 |
| NOT COMPLETED | 24 |
Baseline Characteristics
| Description | |
|---|---|
| Adalimumab 40 mg Eow | adalimumab 40 mg every other week (eow) |
| 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
| 1. Primary: | Number of Subjects With Psoriasis Area and Severity Index (PASI) 75 Response at 16 Weeks [ 16 weeks ] |
| 2. Secondary: | Mean Change and Mean Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 16 and 24 Weeks [ 16 and 24 weeks ] |
| 3. Secondary: | Number of Subjects With Improvement in Physician's Global Assessment for Psoriasis (PGA) [ 16 and 24 weeks ] |
| 4. Secondary: | Number of Subjects Achieving a Clinical Response Defined as a Physician's Global Assessment for Psoriasis (PGA) of "Clear" or “Clear or Minimal” [ 16 and 24 weeks ] |
| 5. Secondary: | Mean Change From Baseline in Physician Global Assessment of Arthritic Disease Activity [ 16 and 24 weeks ] |
| 6. Secondary: | Number of Subjects With Psoriasis Area and Severity Index (PASI) 50/75/90/100 Response [ 16 and 24 weeks ] |
| 7. Secondary: | Mean Change From Baseline in Tender Joint Count [ 16 and 24 weeks ] |
| 8. Secondary: | Mean Change From Baseline in Swollen Joint Count [ 16 and 24 weeks ] |
| 9. Secondary: | Mean Change From Baseline in Patient's Global Assessment of Joint Pain [ 16 and 24 weeks ] |
| 10. Secondary: | Mean Change From Baseline in the Dermatology Life Quality Index (DLQI) [ 16 and 24 weeks ] |
| 11. Secondary: | Number of Subjects Achieving a Dermatology Life Quality Index (DLQI) = 0 [ 16 and 24 weeks ] |
| 12. Secondary: | Mean Change From Baseline in Beck Depression Inventory (BDI-II) [ 16 and 24 weeks ] |
More Information
| 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:
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| 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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| Responsible Party: | Abbott ( Isabel Pereira, Affiliate Project Manager ) |
| Study ID Numbers: | W10-151 |
| Study First Received: | August 6, 2007 |
| Results First Received: | August 21, 2009 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00513370 History of Changes |
| Health Authority: | Canada: Health Canada |