Open Label Study of Adalimumab in Subjects Who Have a Sub... | NCT00566722

Status Module

Description Module

Detailed Description

This 16-week multicenter, open-label study was designed to evaluate the efficacy and safety of a loading dose of 80 mg adalimumab, followed by 40 mg adalimumab every other week in the treatment of psoriasis in patients with a sub-optimal response to etanercept, methotrexate (MTX), or Narrow band Ultraviolet - B (NB-UVB).

Approximately 150 participants were planned for 3 sub-studies: 80 participants with sub-optimal response to etanercept, 40 participants with sub-optimal response to MTX, and 30 participants with sub-optimal response to NB-UVB. Actual enrollment was 82 participants with sub-optimal response to etanercept, 41 participants with sub-optimal response to MTX, and 29 participants with sub-optimal response to NB-UVB.

Screening was performed at least 96 hours and no more than 31 days before the Baseline visit (Week 0). A participant who was eligible for the study based on sub-optimal response to one treatment (MTX, NB-UVB, or etanercept) was required to discontinue that treatment within a specified time before first dose of adalimumab (see descriptions of sub-study groups). In addition, if the participant was also receiving another qualifying treatment, he/she was required to have discontinued the other treatment at least 30 days before the Baseline visit (Week 0).

Adalimumab was administered by subcutaneous (SC) injection. At the Baseline Visit (Week 0), all participants received an initial dose of 80 mg adalimumab SC. Every other week (odd-numbered weeks) from Week 1 to Week 15, participants received 40 mg adalimumab SC.

This was a single group assignment study, that is, all participants received the same treatment; however, data were summarized for 3 groups (sub-studies) that were defined by psoriasis treatments participants received before entering this study: methotrexate, etanercept, or narrow-band, ultraviolet-B.

Efficacy was evaluated using the Physician's Global Assessment (PGA) of disease severity, and patient-reported outcomes: Patient's Global Assessment (PTGA) of disease severity, the Psoriasis-related Pruritus Assessment, the Dermatology Life Quality Index (DLQI), a visual analog scale (VAS) for plaque psoriasis and psoriatic arthritis pain, the Medical Outcomes Study (MOS) Sleep Scale, and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI: SHP).

Serious and nonserious adverse events were summarized by sub-study of participants (suboptimal response to MTX, suboptimal response to NB-UVB, and suboptimal response to etanercept).

Label	Type	Description	Intervention Names
Open Label	Experimental		Biological: adalimumab

Name	Type	Description	Arm Group Labels	Other Names
adalimumab	Biological	Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.

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

Measure	Description	Time Frame
Number of Participants Achieving a PGA of Clear (0) at Week 16		Week 16
Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening		From Screening to Week 16

Eligibility Module

Name	Affiliation	Role
Martin M Okun, M.D., Ph.D.	Abbott	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Total Skin and Beauty Dermatology Centers		Birmingham	Alabama	35205	United States
Dermatology Research of Arkansas

PubMed Identifier	Type	Citation	Retractions
21414495	Derived	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. doi: 10.1016/j.jaad.2010.03.009.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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]).

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.

Posted

Number

Participants

Week 16

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG00041 OG00129 OG00282

Title

Denominators

Categories

Title	Measurements
	OG00025 OG00114 OG00240

Secondary

Number of Participants Achieving a PGA of Clear (0) at Week 16

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.

Posted

Number

Participants

Week 16

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants Achieving at Least 1 Grade of Improvement in PGA at Week 16 Compared to Screening

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.

Posted

Number

Participants

From Screening to Week 16

ID	Title	Description
OG000	Sub-optimal Response to MTX
OG001	Sub-optimal Response to Narrow-band Ultraviolet-B
OG002	Sub-optimal Response to Etanercept

Units	Counts
Participants	OG000

Secondary

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

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.

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.

Posted

Number

Participants

Weeks 2, 4, and 8

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Dermatology Life Quality Index (DLQI) Total Score

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.

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

Posted

Mean

Standard Deviation

Change in scores on a scale

From Screening to Week 4 and Week 16

ID	Title	Description
OG000	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.
OG001	Sub-optimal Response to Narrow-band Ultraviolet-B

Secondary

Number of Participants Achieving DLQI Total Score of 0 at Week 4 and Week 16

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

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

Posted

Number

Participants

Week 4 and Week 16

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Psoriasis-related Pruritus Assessment

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.

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

Posted

Mean

Standard Deviation

Change in scores on a scale

From Screening to Week 16

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Visual Analog Scale (VAS) for Pain Involving Psoriatic Plaques and/or Psoriatic Arthritis

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.

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

Posted

Mean

Standard Deviation

Change in scores on a scale

From Screening to Week 16

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percent Work Time Missed Due to Psoriasis

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%.

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.

Posted

Mean

Standard Deviation

Change in percent time missed

From Screening to Week 16

ID	Title	Description
OG000	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.

Secondary

Percent Overall Work Impairment Due to Psoriasis

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.

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.

Posted

Mean

Standard Deviation

Change in % overall work impairment

From Screening to Week 16

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percent Impairment While Working Due to Psoriasis

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.

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.

Posted

Mean

Standard Deviation

Change in % impairment while working

From Screening to Week 16

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Percent Activity Impairment Due to Psoriasis

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%.

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.

Posted

Mean

Standard Deviation

Change in percent activity impairment

From Screening to Week 16

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Sleep Problems Index II

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.

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 for all items; as a result, not all participants were included in the analysis.

Posted

Mean

Standard Deviation

Change in scores on a scale

From Screening to Week 16

ID	Title	Description
OG000	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.
OG001

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	0	41	19	41
EG001	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.	1	29	12	29
EG002	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.	4	82	20	82

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0010 affected29 at risk EG0021 affected82 at risk
Diverticulitis Meckel's	Congenital, familial and genetic disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0010 affected29 at risk EG0021 affected82 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0010 affected29 at risk EG0021 affected82 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0010 affected29 at risk EG0021 affected82 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0010 affected29 at risk EG0021 affected82 at risk
Cellulitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Helicobacter pylori identification test positive	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0010 affected29 at risk EG0021 affected82 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0010 affected29 at risk EG0021 affected82 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Glaucoma	Eye disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0020 affected82 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0021 affected82 at risk
Dental caries	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Toothache	Gastrointestinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Fatigue	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0012 affected29 at risk EG0022 affected82 at risk
Injection site erythema	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0003 affected41 at risk EG0011 affected29 at risk EG0021 affected82 at risk
Injection site haemorrhage	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Injection site pain	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Injection site reaction	General disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0020 affected82 at risk
Bronchitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0020 affected82 at risk
Cellulitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Folliculitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0021 affected82 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0003 affected41 at risk EG0010 affected29 at risk EG0023 affected82 at risk
Pharyngitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0012 affected29 at risk EG0020 affected82 at risk
Sinusitis	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (11.1)	Non-systematic Assessment	EG0005 affected41 at risk EG0011 affected29 at risk EG0025 affected82 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0021 affected82 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0022 affected82 at risk
Sunburn	Injury, poisoning and procedural complications	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0020 affected82 at risk
Blood triglycerides increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
C-reactive protein abnormal	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Eosinophil count increased	Investigations	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected29 at risk EG0022 affected82 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0011 affected29 at risk EG0021 affected82 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0023 affected82 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0023 affected82 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0020 affected82 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Non-systematic Assessment	EG0002 affected41 at risk EG0010 affected29 at risk EG0020 affected82 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0000 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Non-systematic Assessment	EG0001 affected41 at risk EG0011 affected29 at risk EG0020 affected82 at risk

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins