Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00735787
• Collaborator: (none)
• Enrollment: 81
• Locations: 17
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Biological: Placebo; Biological: Adalimumab	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo/Adalimumab Loading dose of 2 placebo injections at Week 0 and placebo injections every other week (eow) from Week 1 through Week 15. In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	Biological: Placebo; Loading dose of 2 placebo subcutaneous (SC) injections (0.8 ml) at Week 0 followed by 1 injection SC eow from Week 1 to Week 15.In second period of study, subjects who continued in the study received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.; Biological: Adalimumab; Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.; Other Names: Humira ABT-D2E7
Active Comparator: Adalimumab 80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 15. For subjects who continued in the second period of the study, subjects received 2 placebo injections at Week 16 to maintain the blind. Open-label 40 mg adalimumab eow was administered from Week 17 through Week 27.	Biological: Adalimumab; Loading dose of 80 mg adalimumab SC (two 40 mg injections) followed by 40 mg adalimumab SC eow.; Other Names: Humira ABT-D2E7

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16 [Week 16]

   Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

Secondary Outcome Measures

1. Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF) [Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28]

   Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.

2. Mean Change From Baseline in ESIF for Palms [Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28]

   Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.

3. Mean Change From Baseline in ESIF for Soles [Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28]

   Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.

4. Number of Subjects With Moderate Improvement in ESIF From Baseline [Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28]

   Number of subjects that achieved > 50% reduction from Baseline in ESIF.

5. Number of Subjects With Marked Improvement in ESIF From Baseline [Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28]

   Number of subjects that achieved > 75% reduction from Baseline in ESIF

6. Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) [Baseline and Weeks 8, 16, and 28]

   For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).

7. Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild [Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28]

   Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

8. Number of Subjects With PGA of Clear or Almost Clear [Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28]

   Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

9. Number of Subjects With PGA of Clear [Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28]

   Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.

10. Number of Subjects With Psoriasis Area and Severity Index (PASI) 50 [Baseline and Weeks 16 and 28]

    Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).

11. Number of Subjects With PASI 75 [Baseline and Weeks 16 and 28]

    Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).

12. Number of Subjects With PASI 90 [Baseline and Weeks 16 and 28]

    Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).

13. Number of Subjects With PASI 100 [Baseline and Weeks 16 and 28]

    Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).

14. Mean Change From Baseline in Dermatology Life Quality Index (DLQI) [Baseline and Weeks 2, 8, 16, and 28]

    The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.

15. Number of Subjects Achieving a DLQI of 0 [Baseline and Weeks 2, 8, 16, and 28]

    Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.

16. Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain [Baseline and Weeks 16 and 28]

    On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).

17. Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO) [Baseline and Weeks 8, 16, and 28]

    WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).

18. Mean Change From Baseline in Patient Health Questionnaire (PHQ-9) [Baseline and Weeks 2, 8, 16, and 28]

    The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).

19. Number of Subjects With Difficulties According to PHQ-9 [Baseline and Weeks 2, 8, 16, and 28]

    Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA >/=3 and candidates for systemic therapy;

• Patients in good general health

• Able to self-administer injections

• Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis

Exclusion Criteria:

• Previous treatment with HUMIRA®

• Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)

• Other active skin diseases or skin infections

• Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis

• Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);

• History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB);

• History of moderate to severe congestive heart failure,

• Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk;

• History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease;

• History of clinically significant drug or alcohol abuse in the last 12 months;

• Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline;

• Known hypersensitivity to the excipients of HUMIRA® as stated in the label;

• Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.

• Prior exposure to Tysabri® (natalizumab)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site Reference ID/Investigator# 10168	Little Rock	Arkansas	United States	72205
2	Site Reference ID/Investigator# 10005	Bakersfield	California	United States	93309
3	Site Reference ID/Investigator# 10003	Macon	Georgia	United States	31217
4	Site Reference ID/Investigator# 10171	St. Louis	Missouri	United States	63117
5	Site Reference ID/Investigator# 10164	East Windsor	New Jersey	United States	08520
6	Site Reference ID/Investigator# 10173	Dallas	Texas	United States	75246-1613
7	Site Reference ID/Investigator# 11302	Houston	Texas	United States	77030
8	Site Reference ID/Investigator# 10166	San Antonio	Texas	United States	78258
9	Site Reference ID/Investigator# 10180	Edmonton	Alberta	Canada	T5K 1X3
10	Site Reference ID/Investigator# 10169	Vancouver	British Columbia	Canada	V5Z 4E8
11	Site Reference ID/Investigator# 10170	Halifax	Nova Scotia	Canada	B3H 1Z4
12	Site Reference ID/Investigator# 10179	Hamilton	Ontario	Canada	L8N 1V6
13	Site Reference ID/Investigator# 10004	London	Ontario	Canada	N5X 2P1
14	Site Reference ID/Investigator# 10177	North Bay	Ontario	Canada	P1B 3Z7
15	Site Reference ID/Investigator# 10175	Waterloo	Ontario	Canada	N2J 1C4
16	Site Reference ID/Investigator# 10165	Montreal	Quebec	Canada	H2K 4L5
17	Site Reference ID/Investigator# 10176	Quebec		Canada	G1V 4X7

Sponsors and Collaborators

• Abbott

Investigators

• Study Director: Martin Okun, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• prescribing information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00735787
• Other Study ID Numbers: M10-405
• First Posted: Aug 15, 2008
• Last Update Posted: Nov 1, 2010
• Last Verified: Oct 1, 2010

• Additional relevant MeSH terms: Psoriasis; Adalimumab

Study Results

Participant Flow

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Period Title: Period 1
STARTED	23	49
COMPLETED	17	41
NOT COMPLETED	6	8
Period Title: Period 1
STARTED	18	41
COMPLETED	13	40
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	Placebo/Adalimumab	Adalimumab	Total
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.	Total of all reporting groups
Overall Participants	23	49	72
Age (subjects) [Number]
< 40 years	1	11	12
Between 40 and < 60 years	14	29	43
>= 60 years	8	9	17
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.8 (11.40)	49.0 (11.41)	50.9 (11.65)
Sex: Female, Male (Count of Participants)
Female	15 65.2%	28 57.1%	43 59.7%
Male	8 34.8%	21 42.9%	29 40.3%
Region of Enrollment (participants) [Number]
United States	9 39.1%	20 40.8%	29 40.3%
Canada	14 60.9%	29 59.2%	43 59.7%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
Description	Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time Frame	Week 16

Outcome Measure Data

Analysis Population Description

Analysis was based on the intention to treat (ITT) subject population. Subjects who did not achieve PGA assessments at Week 16 were imputed as non-responders.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Number [subjects]	1	15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo/Adalimumab, Adalimumab
	Comments	The primary null hypothesis for this study was that there was no difference in the proportion of subjects that achieved PGA clear or almost clear at Week 16 between the adalimumab and placebo groups. Analysis was done using a two-sided Fisher's exact test at alpha level=0.05.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)
Description	Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the two soles and two palms, for a total range from 0 (no disease) to 48 points (most severe condition). A decrease from Baseline in ESIF indicates improvement.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using last observation carried forward (LOCF) method.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	-2.35 (4.074)	-6.24 (7.685)
Week 4	-1.91 (7.019)	-7.73 (9.064)
Week 8	-3.04 (7.327)	-9.33 (9.335)
Week 12	-5.30 (6.825)	-10.80 (11.175)
Week 16	-5.04 (6.568)	-10.92 (12.460)
Week 20 (open-label)	-6.43 (8.805)	-11.69 (11.353)
Week 24 (open-label)	-5.83 (9.267)	-11.51 (11.502)
Week 28 (open-label)	-5.83 (8.574)	-11.96 (10.261)

3. Secondary Outcome

Title	Mean Change From Baseline in ESIF for Palms
Description	Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the palms of the hands, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the palms. A decrease from Baseline in ESIF indicates improvement.
Time Frame	Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using the LOCF method.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	-1.78 (3.464)	-3.33 (4.095)
Week 4	-1.57 (4.326)	-4.33 (4.543)
Week 8	-2.09 (4.889)	-5.35 (4.829)
Week 12	-3.39 (4.639)	-5.53 (5.934)
Week 16	-2.65 (4.914)	-5.80 (6.285)
Week 20 (open-label)	-3.87 (5.810)	-6.16 (5.669)
Week 24 (open-label)	-3.74 (5.387)	-6.08 (5.947)
Week 28 (open-label)	-3.52 (4.870)	-6.59 (5.244)

4. Secondary Outcome

Title	Mean Change From Baseline in ESIF for Soles
Description	Severity of each sign of ESIF was assessed using a 4-point scale (0 = clear, 1 = mild, 2 = moderate, and 3 = severe). The ESIF was calculated by adding the scores for the 4 signs for the soles of the feet, yielding a total range from 0 (no disease) to 24 points (most severe condition) for the soles. A decrease from Baseline in ESIF indicates improvement.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using the LOCF method.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	-0.57 (1.619)	-2.92 (4.650)
Week 4	-0.35 (3.915)	-3.39 (5.553)
Week 8	-0.96 (4.017)	-4.04 (5.972)
Week 12	-1.91 (3.965)	-5.35 (6.515)
Week 16	-2.39 (4.620)	-5.18 (7.132)
Week 20 (open-label)	-2.57 (5.358)	-5.47 (6.959)
Week 24 (open-label)	-2.09 (5.608)	-5.37 (7.082)
Week 28 (open-label)	-2.30 (5.431)	-5.31 (6.378)

5. Secondary Outcome

Title	Number of Subjects With Moderate Improvement in ESIF From Baseline
Description	Number of subjects that achieved > 50% reduction from Baseline in ESIF.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	1	8
Week 4	2	10
Week 8	3	17
Week 12	6	20
Week 16	4	21
Week 20 (open-label)	6	19
Week 24 (open-label)	6	21
Week 28 (open-label)	3	19

6. Secondary Outcome

Title	Number of Subjects With Marked Improvement in ESIF From Baseline
Description	Number of subjects that achieved > 75% reduction from Baseline in ESIF
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	0	3
Week 4	0	5
Week 8	0	7
Week 12	0	11
Week 16	1	14
Week 20 (open-label)	5	13
Week 24 (open-label)	4	12
Week 28 (open-label)	2	11

7. Secondary Outcome

Title	Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Description	For subjects with psoriasis nail involvement at Baseline, the target fingernail (most severely involved fingernail at Baseline) was assessed for NAPSI throughout the study. NAPSI ranges from 0 (no nail psoriasis) to 8 (most severe nail psoriasis).
Time Frame	Baseline and Weeks 8, 16, and 28

Outcome Measure Data

Analysis Population Description

Analysis was performed in the ITT subject population for subjects with nail involvement at baseline only and is based on LOCF.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	8	28
Week 8	-0.63 (1.061)	-0.88 (1.211)
Week 16	-0.13 (1.246)	-1.67 (1.593)
Week 28 (open-label)	-1.00 (1.852)	-2.00 (2.177)

8. Secondary Outcome

Title	Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild
Description	Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis), almost clear (representing just perceptible erythema and scaling), or mild (representing light pink erythema with minimal scaling and with or without pustules). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	2	15
Week 4	3	21
Week 8	6	21
Week 12	8	24
Week 16	6	25
Week 20 (open-label)	8	23
Week 24 (open-label)	7	20
Week 28 (open-label)	4	23

9. Secondary Outcome

Title	Number of Subjects With PGA of Clear or Almost Clear
Description	Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using non-responder imputation (NRI).

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	1	4
Week 4	1	10
Week 8	2	12
Week 12	3	14
Week 20 (open-label)	5	11
Week 24 (open-label)	5	12
Week 28 (open-label)	2	12

10. Secondary Outcome

Title	Number of Subjects With PGA of Clear
Description	Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis). The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
Time Frame	Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using NRI.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	0	1
Week 4	0	2
Week 8	0	3
Week 12	0	6
Week 16	1	6
Week 20 (open-label)	2	8
Week 24 (open-label)	3	7
Week 28 (open-label)	2	7

11. Secondary Outcome

Title	Number of Subjects With Psoriasis Area and Severity Index (PASI) 50
Description	Number of subjects who achieved 50% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time Frame	Baseline and Weeks 16 and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using NRI.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 16	5	21
Week 28 (open-label)	8	21

12. Secondary Outcome

Title	Number of Subjects With PASI 75
Description	Number of subjects who achieved 75% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time Frame	Baseline and Weeks 16 and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using NRI.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 16	2	15
Week 28 (open-label)	4	11

13. Secondary Outcome

Title	Number of Subjects With PASI 90
Description	Number of subjects who achieved 90% or greater improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time Frame	Baseline and Weeks 16 and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using NRI.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 16	0	10
Week 28 (open-label)	4	10

14. Secondary Outcome

Title	Number of Subjects With PASI 100
Description	Number of subjects who achieved 100% improvement from baseline PASI. The PASI scale is from 0 (no psoriasis) to 72 (complete erythroderma of the severest possible degree).
Time Frame	Baseline and Weeks 16 and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using NRI.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 16	0	7
Week 28 (open-label)	1	8

15. Secondary Outcome

Title	Mean Change From Baseline in Dermatology Life Quality Index (DLQI)
Description	The DLQI consists of 10 questions and is scored from 0 (total lack of impairment) to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Time Frame	Baseline and Weeks 2, 8, 16, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using LOCF.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	-3.43 (3.435)	-4.35 (4.741)
Week 8	-3.09 (5.008)	-4.08 (5.541)
Week 16	-4.22 (4.936)	-4.78 (7.269)
Week 28 (open-label)	-4.74 (4.731)	-5.18 (7.499)

16. Secondary Outcome

Title	Number of Subjects Achieving a DLQI of 0
Description	Number of subjects achieving a DLQI score of 0, indicating total lack of impairment. The DLQI consists of 10 questions and is scored from 0 to 30 (life is very much impaired). A decrease in DLQI indicates improvement.
Time Frame	Baseline and Weeks 2, 8, 16, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using NRI.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	1	3
Week 8	1	3
Week 16	0	7
Week 28 (open-label)	1	6

17. Secondary Outcome

Title	Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain
Description	On one single VAS, subjects assessed their pain due to psoriasis (and psoriatic arthritis, if applicable). Mean change in psoriasis and psoriatic arthritis pain from Baseline as measured by a VAS from 0 (no pain) to 100 (pain as bad as it could be).
Time Frame	Baseline and Weeks 16 and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using LOCF.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 16	-12.45 (28.637)	-17.49 (34.451)
Week 28 (open-label)	-16.25 (24.950)	-16.59 (34.430)

18. Secondary Outcome

Title	Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)
Description	WPAI:PSO assesses the effect on the subject's ability to work and perform regular activities in 4 areas: % work time (in hours) missed due to psoriasis, % impairment while working (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), % overall work impairment (on a scale from 0 [psoriasis having no effect] to 10 [psoriasis completely prevented subject from working]), and % activity impairment (on a scale from 0 [psoriasis having no effect on daily activities] to 10 [psoriasis completely prevented subject from doing daily activities]).
Time Frame	Baseline and Weeks 8, 16, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using LOCF.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
% Work Time Missed due to Psoriasis Week 8	6.32 (24.953)	4.70 (12.778)
% Work Time Missed due to Psoriasis Week 16	7.72 (33.299)	5.34 (20.250)
% Work Time Missed due to Psoriasis Week 28 (OL)	2.60 (26.628)	3.16 (18.198)
% Impairment While Working Week 8	0.71 (29.733)	-8.21 (27.087)
% Impairment While Working Week 16	-4.67 (20.656)	-5.94 (27.103)
% Impairment While Working Week 28 (OL)	-5.33 (20.999)	-8.44 (31.429)
% Overall Work Impairment Week 8	-0.48 (29.988)	-8.97 (27.355)
% Overall Work Impairment Week 16	-5.45 (22.432)	-7.19 (26.556)
% Overall Work Impairment Week 28 (OL)	-5.79 (20.996)	-9.88 (31.045)
% Activity Impairment Week 8	-9.09 (32.500)	-11.02 (23.562)
% Activity Impairment Week 16	-9.09 (22.234)	-13.88 (27.600)
% Activity Impairment Week 28 (OL)	-15.91 (27.196)	-14.69 (32.539)

19. Secondary Outcome

Title	Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)
Description	The PHQ-9 consists of 9 questions that assess how often over the past 2 weeks subjects had signs or symptoms of depression (0=not at all, 1=several days, 2=more than half days, and 3=nearly every day). The PHQ-9 is the sum of the scores from the 9 questions for a total range from 0 (not depressed at all) to 27 (depressed nearly every day).
Time Frame	Baseline and Weeks 2, 8, 16, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population and performed using LOCF.

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Week 2	-2.85 (4.332)	-2.86 (4.449)
Week 8	-2.43 (4.057)	-1.80 (4.796)
Week 16	-2.64 (6.637)	-2.14 (4.659)
Week 28 (open-label)	-3.32 (5.719)	-2.65 (5.031)

20. Secondary Outcome

Title	Number of Subjects With Difficulties According to PHQ-9
Description	Based on the 9 questions of the PHQ-9, if subjects indicated any problems (PHQ-9 score > 0), the difficulty to do work, take care of things at home, and get along with people (question 10 of the PHQ) were assessed (not difficult at all, somewhat difficult, very difficult, and extremely difficult).
Time Frame	Baseline and Weeks 2, 8, 16, and 28

Outcome Measure Data

Analysis Population Description

Analysis was based on the ITT subject population. Missing values were imputed as "extremely difficult."

Arm/Group Title	Placebo/Adalimumab	Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.	80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
Measure Participants	23	49
Not difficult at all - Baseline	4	20
Somewhat difficult - Baseline	9	19
Very difficult - Baseline	3	5
Extremely difficult - Baseline	7	5
Not difficult at all - Week 2	5	21
Somewhat difficult - Week 2	9	16
Very difficult - Week 2	2	3
Extremely difficult - Week 2	7	9
Not difficult at all - Week 8	4	18
Somewhat difficult - Week 8	8	15
Very difficult - Week 8	2	5
Extremely difficult - Week 8	9	11
Not difficult at all - Week 16	3	19
Somewhat difficult - Week 16	8	10
Very difficult - Week 16	2	1
Extremely difficult - Week 16	10	19
Not difficult at all - Week 28 (OL)	4	21
Somewhat difficult - Week 28 (OL)	5	6
Very difficult - Week 28 (OL)	2	1
Extremely difficult - Week 28 (OL)	12	21

Adverse Events

Time Frame	All adverse events (AEs) from the time of study drug administration until 70 days following completion (Week 28) or discontinuation of study drug administration.
Adverse Event Reporting Description	For subjects who continued adalimumab therapy (commercial) after discontinuation of study treatment, AEs that occurred after the first dose of non-study provided adalimumab were not to be report in this study, but rather via the usual post-marketing reporting process.
Arm/Group Title	Placebo/Adalimumab		Adalimumab
Arm/Group Description	Placebo injections every other week (eow) up to Week 15. In second period of study, subjects who continued to participate received 80 mg adalimumab at Week 16 followed by open-label 40 mg adalimumab eow from Week 17 to Week 27.		80 mg adalimumab loading dose at Week 0 and 40 mg adalimumab eow from Weeks 1 through 27. Subjects received 2 placebo injections at Week 16 to maintain the blind.
All Cause Mortality
	Placebo/Adalimumab		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo/Adalimumab		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/23 (4.3%)		2/49 (4.1%)
Cardiac disorders
Acute myocardial infarction	0/23 (0%)		1/49 (2%)
Gastrointestinal disorders
Gastrointestinal haemorrhage	0/23 (0%)		1/49 (2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/23 (4.3%)		0/49 (0%)
Reproductive system and breast disorders
Breast mass	1/23 (4.3%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Placebo/Adalimumab		Adalimumab
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/23 (65.2%)		30/49 (61.2%)
Gastrointestinal disorders
Diarrhoea	3/23 (13%)		1/49 (2%)
Gastrooesophageal reflux disease	2/23 (8.7%)		0/49 (0%)
Nausea	2/23 (8.7%)		0/49 (0%)
Toothache	2/23 (8.7%)		0/49 (0%)
General disorders
Injection site reaction	2/23 (8.7%)		2/49 (4.1%)
Oedema peripheral	2/23 (8.7%)		2/49 (4.1%)
Infections and infestations
Bronchitis	3/23 (13%)		1/49 (2%)
Gastroenteritis	1/23 (4.3%)		3/49 (6.1%)
Nasopharyngitis	3/23 (13%)		13/49 (26.5%)
Pharyngitis	1/23 (4.3%)		3/49 (6.1%)
Sinusitis	1/23 (4.3%)		3/49 (6.1%)
Upper respiratory tract infection	0/23 (0%)		4/49 (8.2%)
Urinary tract infection	2/23 (8.7%)		0/49 (0%)
Injury, poisoning and procedural complications
Joint sprain	0/23 (0%)		3/49 (6.1%)
Musculoskeletal and connective tissue disorders
Pain in extremity	1/23 (4.3%)		3/49 (6.1%)
Nervous system disorders
Headache	1/23 (4.3%)		7/49 (14.3%)
Psychiatric disorders
Insomnia	2/23 (8.7%)		0/49 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/23 (4.3%)		4/49 (8.2%)
Skin and subcutaneous tissue disorders
Pruritus	2/23 (8.7%)		1/49 (2%)
Psoriasis	2/23 (8.7%)		2/49 (4.1%)
Urticaria	2/23 (8.7%)		3/49 (6.1%)

Limitations/Caveats

Based on one investigator's non-compliance with the protocol at one site, ITT analyses were conducted in a smaller number of subjects that excluded all 9 subjects from this one site.

More Information

Certain Agreements

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

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