Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Japanese subjects with chronic plaque psoriasis who completed the blinded, placebo-controlled Study M04-688 (NCT # 00338754; 24-week duration) enrolled in the extension study, M04-702, an open-label study until adalimumab received approval for treatment of psoriasis.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Interim results are shown for subjects after 28 or 52 weeks of treatment. Subjects who completed M04-688 and received placebo were treated with 40 or 80 mg adalimumab every other week (eow) for 28 weeks. Subjects who completed M04-688 and received adalimumab continued this regimen for 52 weeks. Non-responders could increase dosage to 80 mg eow.

Reporting Groups

	Description
Adalimumab 40 mg Every Other Week	This arm comprised subjects treated with 40 mg every other week or placebo in study M04-688 (NCT# 00338754). Subjects were allowed to increase dosage to 80 mg if they did not respond to treatment at 40 mg. Subjects with increased dosages were not permitted to decrease dosage later.
Adalimumab 80 mg Every Other Week	This arm comprised subjects treated with 80 mg every other week and placebo in study M04-688 (NCT# 00338754).

Participant Flow:   Overall Study

	Adalimumab 40 mg Every Other Week	Adalimumab 80 mg Every Other Week
STARTED	89[1]	58[2]
COMPLETED	83[3]	53[4]
NOT COMPLETED	6	5

Reporting Groups

	Description
Adalimumab 40 mg Every Other Week	This arm comprised subjects treated with 40 mg every other week or placebo in study M04-688 (NCT# 00338754). Subjects were allowed to increase dosage to 80 mg if they did not respond to treatment at 40 mg. Subjects with increased dosages were not permitted to decrease dosage later.
Adalimumab 80 mg Every Other Week	This arm comprised subjects treated with 80 mg every other week and placebo in study M04-688 (NCT# 00338754).

Baseline Measures

	Adalimumab 40 mg Every Other Week	Adalimumab 80 mg Every Other Week	Total
Number of Participants   [units: participants]	89	58	147
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	80	56	136
>=65 years	9	2	11
Age   [units: years] Mean ± Standard Deviation	45.1 ± 13.39	42.9 ± 11.88	44.2 ± 12.82
Gender   [units: participants]
Female	13	10	23
Male	76	48	124
Region of Enrollment   [units: participants]
Japan	89	58	147

1.  Primary:

Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score.   [ Time Frame: Week 2, Week 4, and then every 4 weeks through Week 40 and at Week 52 ]

2.  Secondary:

Number of Participants With a 75% and 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score.   [ Time Frame: Week 2, Week 4, and then every 4 weeks through Week 40 and at Week 52 ]

3.  Secondary:

Incidence of Adverse Events   [ Time Frame: Until Approval ]