Trial Outcomes & Findings for Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy (NCT NCT00566722)

Last Updated: 2011-04-12

Results Overview

The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe \[extreme red coloration, dusky to deep red coloration\]).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

152 participants

Primary outcome timeframe

Week 16

Results posted on

2011-04-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	41	29	82
Overall Study COMPLETED	39	24	73
Overall Study NOT COMPLETED	2	5	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	0	1	0
Overall Study Withdrawal by Subject	0	0	1
Overall Study Lost to Follow-up	1	1	1
Overall Study Lack of Efficacy	1	2	4
Overall Study Did not meet exclusion criteria	0	0	2
Overall Study Serious adverse event	0	1	0
Overall Study Noncompliant with drug administration	0	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=82 Participants 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 n=152 Participants Total of all reporting groups
Age Continuous	47.4 years STANDARD_DEVIATION 13.11 • n=5 Participants	45.7 years STANDARD_DEVIATION 14.60 • n=7 Participants	48.3 years STANDARD_DEVIATION 13.70 • n=5 Participants	47.6 years STANDARD_DEVIATION 13.67 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	35 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	16 Participants n=7 Participants	47 Participants n=5 Participants	91 Participants n=4 Participants
Region of Enrollment United States	26 participants n=5 Participants	10 participants n=7 Participants	70 participants n=5 Participants	106 participants n=4 Participants
Region of Enrollment Canada	15 participants n=5 Participants	19 participants n=7 Participants	12 participants n=5 Participants	46 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 16

Population: All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear or minimal not achieved) was used for missing data.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=82 Participants 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.
Number of Participants Who Achieved a Physician's Global Assessment (PGA) of Clear (0) or Minimal (1) at Week 16	25 Participants	14 Participants	40 Participants

SECONDARY outcome

Timeframe: Week 16

Population: All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (PGA of clear \[0\] not achieved) was used for missing data.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=82 Participants 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.
Number of Participants Achieving a PGA of Clear (0) at Week 16	15 Participants	6 Participants	10 Participants

SECONDARY outcome

Timeframe: From Screening to Week 16

Population: All participants who were enrolled and received a dose of adalimumab were included. Non-responder imputation (1 grade of improvement not achieved) was used for missing data.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=82 Participants 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.
Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening	32 Participants	23 Participants	59 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, and 8

Population: All participants who received at least 1 dose of adalimumab are included. Nonresponder imputation was used for missing data; that is, participants who did not have an evaluation at the time point were assumed to not have achieved a 0 or 1 on the PGA.

The Patient's Global Assessment of Psoriasis-Severity is a rating of how well their disease is controlled. 0=complete disease control; 1=good disease control; 2=limited disease control; 3=uncontrolled disease.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=82 Participants 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.
Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 Week 2	5 Participants	0 Participants	9 Participants
Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 Week 4	13 Participants	7 Participants	20 Participants
Number of Participants Achieving 0 or 1 on Patient's Global Assessment at Weeks 2, 4, and 8 Week 8	22 Participants	13 Participants	29 Participants

SECONDARY outcome

Timeframe: From Screening to Week 4 and Week 16

Population: All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.

The DLQI has 10 items and 6 subscales: symptoms and feelings (Q 1 and 2), daily activities (Q 3 and 4), leisure (Q 5 and 6), work and school (Q 7), personal relationships (Q 8 and 9), and treatment (Q 10). Participants rate how much their skin problem affected their life in previous week. Responses are 0 (not at all) to 3=very much. DLQI=total of scores for all items; max=30; min=0.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=80 Participants 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.
Dermatology Life Quality Index (DLQI) Total Score Week 4	-4.8 Change in scores on a scale Standard Deviation 5.89	-5.2 Change in scores on a scale Standard Deviation 5.45	-3.3 Change in scores on a scale Standard Deviation 4.93
Dermatology Life Quality Index (DLQI) Total Score Week 16	-7.0 Change in scores on a scale Standard Deviation 7.45	-6.5 Change in scores on a scale Standard Deviation 6.44	-3.8 Change in scores on a scale Standard Deviation 5.66

SECONDARY outcome

Timeframe: Week 4 and Week 16

Population: All participants who received at least 1 dose of adalimumab were included. Nonresponder imputation (score of 0 not achieved) was used for missing data.

DLQI total score of 0 indicates psoriasis had no effect at all on participant's life.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=82 Participants 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.
Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 Week 4	6 Participants	2 Participants	2 Participants
Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16 Week 16	12 Participants	6 Participants	17 Participants

SECONDARY outcome

Timeframe: From Screening to Week 16

Population: All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data.

The Psoriasis-related Pruritus Assessment is a scale for evaluating pruritus-related to psoriasis over the previous week; values range from 0 (no itching) to 10 (severe itching). A decrease in score indicates an improvement in pruritus.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=81 Participants 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.
Psoriasis-related Pruritus Assessment	-2.9 Change in scores on a scale Standard Deviation 3.90	-3.0 Change in scores on a scale Standard Deviation 2.96	-1.7 Change in scores on a scale Standard Deviation 3.24

SECONDARY outcome

Timeframe: From Screening to Week 16

Population: All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data.

The participant rates his/her pain during the previous week on a 100 mm VAS, from 0=no pain to 100=pain as bad as it could be. A decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=41 Participants 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 n=29 Participants 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 n=81 Participants 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.
Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis	-14.7 Change in scores on a scale Standard Deviation 24.41	-21.4 Change in scores on a scale Standard Deviation 30.01	-12.7 Change in scores on a scale Standard Deviation 29.90

SECONDARY outcome

Timeframe: From Screening to Week 16

Population: All participants who received at least 1 dose of adalimumab are included. Last observation carried forward was used for missing data. Screening data were not available for all participants.

Work and activity impairment due to psoriasis were evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), a 6-item questionnaire that measures effect of psoriasis on number of hours worked and the number of hours missed from work. It also measures the effect on productivity and regular activities: 0=no effect on work/daily activities; 10=psoriasis prevented me from working/doing daily activities. Decreases in values on each part indicate improvement. At Screening, percent time missed in the previous week ranged from 0% to 40%.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=25 Participants 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 n=13 Participants 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 n=52 Participants 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.
Percent Work Time Missed Due to Psoriasis	0.7 Change in percent time missed Standard Deviation 3.43	1.3 Change in percent time missed Standard Deviation 4.75	-0.1 Change in percent time missed Standard Deviation 1.85

SECONDARY outcome

Timeframe: From Screening to Week 16

Population: All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.

Percent overall work impairment was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) (described above). At Screening, overall impairment ranged from 0% to 94%. A decrease in percent overall work impairment indicates improvement.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=25 Participants 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 n=13 Participants 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 n=52 Participants 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.
Percent Overall Work Impairment Due to Psoriasis	-4.0 Change in % overall work impairment Standard Deviation 28.06	-6.4 Change in % overall work impairment Standard Deviation 19.75	-2.8 Change in % overall work impairment Standard Deviation 16.92

SECONDARY outcome

Timeframe: From Screening to Week 16

Population: All participants who received at least 1 dose of study drug were included. Last observation carried forward was used for missing data. Screening data were not available for all participants.

Percent impairment while working was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, impairment while working ranged from 0% to 90%. A decrease in percent impairment indicates improvement.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=29 Participants 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 n=15 Participants 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 n=59 Participants 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.
Percent Impairment While Working Due to Psoriasis	-5.5 Change in % impairment while working Standard Deviation 30.31	-8.0 Change in % impairment while working Standard Deviation 19.35	-1.5 Change in % impairment while working Standard Deviation 18.46

SECONDARY outcome

Timeframe: From Screening to Week 16

Population: All participants who received at least 1 dose of adalimumab were included. Last observation carried forward was using for missing data. Screening data were not available for all participants.

Percent impairment in regular activities was evaluated using the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP), described above. At Screening, activity impairment due to psoriasis ranged from 0% to 90%.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=40 Participants 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 n=27 Participants 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 n=79 Participants 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.
Percent Activity Impairment Due to Psoriasis	-13.3 Change in percent activity impairment Standard Deviation 33.08	-12.2 Change in percent activity impairment Standard Deviation 25.62	-4.7 Change in percent activity impairment Standard Deviation 23.03

SECONDARY outcome

Timeframe: From Screening to Week 16

Sleep Problems Index of the Sleep Scale from the Medical Outcomes Study reflects sleep disturbance, perceived sleep adequacy, daytime somnolence, and awakening short of breath or with headache. Participant rates each item from "none of the time" to "all of the time" for the previous 4 weeks. Scores are transformed to 0 to 100 scale; lower scores indicate less impairment. Decrease in score indicates improvement.

Outcome measures

Outcome measures
Measure	Sub-optimal Response to MTX n=40 Participants 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 n=27 Participants 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 n=79 Participants 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.
Sleep Problems Index II	-9.7 Change in scores on a scale Standard Deviation 18.01	-7.7 Change in scores on a scale Standard Deviation 15.82	-2.0 Change in scores on a scale Standard Deviation 14.57

Adverse Events

Sub-optimal Response to MTX

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Sub-optimal Response to Narrow-band Ultraviolet-B

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Sub-optimal Response to Etanercept

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sub-optimal Response to MTX n=41 participants at risk 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 n=29 participants at risk 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 n=82 participants at risk 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.
Cardiac disorders Coronary artery disease	0.00% 0/41 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	0.00% 0/29 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	1.2% 1/82 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.
Congenital, familial and genetic disorders Diverticulitis Meckel's	0.00% 0/41 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	0.00% 0/29 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	1.2% 1/82 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.
Gastrointestinal disorders Diverticular perforation	0.00% 0/41 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	0.00% 0/29 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	1.2% 1/82 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.
Gastrointestinal disorders Food poisoning	0.00% 0/41 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	0.00% 0/29 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	1.2% 1/82 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.
Gastrointestinal disorders Peritonitis	0.00% 0/41 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	0.00% 0/29 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	1.2% 1/82 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.
Infections and infestations Cellulitis	0.00% 0/41 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	3.4% 1/29 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	0.00% 0/82 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.
Investigations Helicobacter pylori identification test positive	0.00% 0/41 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	0.00% 0/29 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	1.2% 1/82 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.
Metabolism and nutrition disorders Obesity	0.00% 0/41 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	0.00% 0/29 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.	1.2% 1/82 • 26 weeks Treatment-emergent AEs (TEAEs) were defined as any event with an onset date that was after the first dose of study drug and an onset date no more than 70 days (10 weeks) after the last dose of study drug. The treatment period was 16 weeks and the follow-up period was 10 weeks.

Other adverse events

Additional Information

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