Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy - Study Results

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: adalimumab

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients who were previously treated with etanercept, methotrexate (MTX), or narrow-band ultraviolet-B (NB-UVB) and had a sub-optimal response were recruited for participation in the study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who were receiving more than 1 of the treatments (etanercept, MTX, NB-UVB) at the time of screening must have discontinued 1 therapy (e.g., MTX) at least 30 days before first dose of adalimumab and must have discontinued the other therapy (e.g., NB-UVB) during a specified time before first dose of adalimumab. See Detailed Description.

Reporting Groups

	Description
Sub-optimal Response to MTX	MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
Sub-optimal Response to Narrow-band Ultraviolet-B	NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
Sub-optimal Response to Etanercept	Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.

Participant Flow: Overall Study

	Sub-optimal Response to MTX	Sub-optimal Response to Narrow-band Ultraviolet-B	Sub-optimal Response to Etanercept
STARTED	41	29	82
COMPLETED	39	24	73
NOT COMPLETED	2	5	9
Adverse Event	0	1	0
Withdrawal by Subject	0	0	1
Lost to Follow-up	1	1	1
Lack of Efficacy	1	2	4
Did not meet exclusion criteria	0	0	2
Serious adverse event	0	1	0
Noncompliant with drug administration	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
Sub-optimal Response to MTX	MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
Sub-optimal Response to Narrow-band Ultraviolet-B	NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
Sub-optimal Response to Etanercept	Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
Total	Total of all reporting groups

Baseline Measures

	Sub-optimal Response to MTX	Sub-optimal Response to Narrow-band Ultraviolet-B	Sub-optimal Response to Etanercept	Total
Number of Participants [units: participants]	41	29	82	152
Age [units: years] Mean ± Standard Deviation	47.4 ± 13.11	45.7 ± 14.60	48.3 ± 13.70	47.6 ± 13.67
Gender [units: participants]
Female	13	13	35	61
Male	28	16	47	91
Region of Enrollment [units: participants]
United States	26	10	70	106
Canada	15	19	12	46

Outcome Measures

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1. Primary:

Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16 [ Time Frame: Week 16 ]

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2. Secondary:

Number of Participants Achieving a PGA of Clear (0) at Week 16 [ Time Frame: Week 16 ]

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3. Secondary:

Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening [ Time Frame: From Screening to Week 16 ]

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4. Secondary:

Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 [ Time Frame: Weeks 2, 4, and 8 ]

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5. Secondary:

Dermatology Life Quality Index (DLQI) Total Score [ Time Frame: From Screening to Week 4 and Week 16 ]

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6. Secondary:

Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 [ Time Frame: Week 4 and Week 16 ]

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7. Secondary:

Psoriasis-related Pruritus Assessment [ Time Frame: From Screening to Week 16 ]

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8. Secondary:

Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis [ Time Frame: From Screening to Week 16 ]

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9. Secondary:

Percent Work Time Missed Due to Psoriasis [ Time Frame: From Screening to Week 16 ]

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10. Secondary:

Percent Overall Work Impairment Due to Psoriasis [ Time Frame: From Screening to Week 16 ]

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11. Secondary:

Percent Impairment While Working Due to Psoriasis [ Time Frame: From Screening to Week 16 ]

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12. Secondary:

Percent Activity Impairment Due to Psoriasis [ Time Frame: From Screening to Week 16 ]

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13. Secondary:

Sleep Problems Index II [ Time Frame: From Screening to Week 16 ]

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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: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.

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: Global Medical Services
Organization: Abbott
phone: 800-633-9110

No publications provided by Abbott

Publications automatically indexed to this study:

Strober BE, Poulin Y, Kerdel FA, Langley RG, Gu Y, Gupta SR, Okun MM, Papp KA. Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: efficacy and safety results from an open-label study. J Am Acad Dermatol. 2011 Apr;64(4):671-81.

Responsible Party:	Marie Rosenfeld, CRM, Abbott
ClinicalTrials.gov Identifier:	NCT00566722 History of Changes
Other Study ID Numbers:	M10-238
Study First Received:	December 1, 2007
Results First Received:	April 28, 2010
Last Updated:	April 8, 2011
Health Authority:	United States: Food and Drug Administration