Adalimumab in Adult Japanese Subjects With Psoriasis

Phase 2

Completed

Conditions: Psoriasis

Interventions: Biological: adalimumab

Registration Number: NCT00647400

Lead Sponsor: Abbott

Brief Summary: To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis

Detailed Description: This was a continuation trial of adalimumab in participants with moderate to severe chronic plaque psoriasis who had completed Study M04-688 (NCT00338754), a 24-week, double-blind, placebo-controlled study. This study was an open-label extension study that continued until the approval of adalimumab for the treatment of psoriasis in Japan.

During Study M04-688 (NCT00338754), participants received 24 weeks of treatment with adalimumab 40 mg every other week (eow) with or without a loading dose, adalimumab 80 mg eow, or placebo.

At the start of this study, participants who had received adalimumab 40 mg eow or adalimumab 80 mg eow in Study M04-688 (NCT00338754) continued on the same treatment regimen. Participants who had received placebo during Study M04-688 (NCT00338754) were re-randomized at the start of this study to receive adalimumab 40 mg eow or adalimumab 80 mg eow.

Participants in the adalimumab 40 mg eow treatment group who failed to achieve a PASI50 response (\>= 50% reduction in the Psoriasis Area and Severity Index score from Baseline of Study M04-688 \[NCT00338754\]) at or anytime after Week 12 of this study were given the option to increase their dose to adalimumab 80 mg eow. Once the dose was escalated, there was no option to de-escalate dosing back to 40 mg eow. Participants who failed to achieve PASI50 responses while receiving adalimumab 80 mg eow may have been discontinued from the study after evaluating the risk/benefit of further treatment with adalimumab.

At Week 28 of this study, it was mandatory for all participants who started the study in the adalimumab 80 mg eow treatment group (i.e., not including the dose escalators described above) to reduce their dose to adalimumab 40 mg eow, regardless of their response status. Following this mandatory dose reduction, if these participants failed to achieve or maintain PASI50 response, they were permitted to escalate their dose to adalimumab 80 mg eow. There was no option to de-escalate dosing back to 40 mg eow following dose escalation.

Data in this clinical trial results disclosure are analyzed as observed according to treatment received at the start of this study (i.e., adalimumab 40 mg eow or adalimumab 80 mg eow) regardless of subsequent dose escalation. Data are summarized according to participants' cumulative exposure to adalimumab in Study M04-688 (NCT00338754) and this study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 147

Inclusion Criteria

Participants who completed Study M04-688 (NCT00338754)

Exclusion Criteria

Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adalimumab 40 mg every other week	adalimumab	-
Adalimumab 80 mg every other week	adalimumab	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)	Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab	PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)	Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab	PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)	Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab	PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).

Trial Locations

Locations (64): Site Ref # / Investigator 5495
🇯🇵
Hiroshima-city, Japan
Site Ref # / Investigator 5491
🇯🇵
Bunkyo-ku, Japan
Site Ref # / Investigator 5429
🇯🇵
Chiyoda-ku, Japan
Site Ref # / Investigator 5504
🇯🇵
Fukuoka, Japan
Site Ref # / Investigator 5406
🇯🇵
Fukushima-city, Japan
Site Ref # / Investigator 5437
🇯🇵
Fukushima-city, Japan
Site Ref # / Investigator 5401
🇯🇵
Gifu, Japan
Site Ref # / Investigator 5408
🇯🇵
Hamamatsu, Japan
Site Ref # / Investigator 5395
🇯🇵
Iwate, Japan
Site Ref # / Investigator 5462
🇯🇵
Kagoshima, Japan
Site Ref # / Investigator 5399
🇯🇵
Sapporo, Japan
Site Ref # / Investigator 5497
🇯🇵
Suita-city, Japan
Site Ref # / Investigator 5400
🇯🇵
Fukushima-city, Japan
Site Ref # / Investigator 5391
🇯🇵
Hokkaido, Japan
Site Ref # / Investigator 5477
🇯🇵
Fukuoka, Japan
Site Ref # / Investigator 5492
🇯🇵
Fukuoka, Japan
Site Ref # / Investigator 5434
🇯🇵
Gifu, Japan
Site Ref # / Investigator 5464
🇯🇵
Fukuoka, Japan
Site Ref # / Investigator 5407
🇯🇵
Fukushima-city, Japan
Site Ref # / Investigator 5431
🇯🇵
Itabashi-ku, Japan
Site Ref # / Investigator 5402
🇯🇵
Ishikawa, Japan
Site Ref # / Investigator 5476
🇯🇵
Kagoshima, Japan
Site Ref # / Investigator 5435
🇯🇵
Kanagawa, Japan
Site Ref # / Investigator 5503
🇯🇵
Kyoto, Japan
Site Ref # / Investigator 5432
🇯🇵
Kawachi-gun, Japan
Site Ref # / Investigator 5499
🇯🇵
Kyoto, Japan
Site Ref # / Investigator 5440
🇯🇵
Kawasaki-city, Japan
Site Ref # / Investigator 5411
🇯🇵
Minato-ku, Japan
Site Ref # / Investigator 5463
🇯🇵
Nagasaki, Japan
Site Ref # / Investigator 5404
🇯🇵
Mitaka, Japan
Site Ref # / Investigator 5427
🇯🇵
Nagoya-city, Japan
Site Ref # / Investigator 5467
🇯🇵
Osaka-city, Japan
Site Ref # / Investigator 5417
🇯🇵
Miyagi, Japan
Site Ref # / Investigator 5493
🇯🇵
Nankoku-city, Japan
Site Ref # / Investigator 5465
🇯🇵
Nankoku-city, Japan
Site Ref # / Investigator 5482
🇯🇵
Nishinomiya-city, Japan
Site Ref # / Investigator 5496
🇯🇵
Okayama-city, Japan
Site Ref # / Investigator 5480
🇯🇵
Osaka-city, Japan
Site Ref # / Investigator 5483
🇯🇵
Osaka-city, Japan
Site Ref # / Investigator 5498
🇯🇵
Osaka-city, Japan
Site Ref # / Investigator 5441
🇯🇵
Osaka-city, Japan
Site Ref # / Investigator 5388
🇯🇵
Sapporo, Japan
Site Ref # / Investigator 5396
🇯🇵
Sapporo, Japan
Site Ref # / Investigator 5505
🇯🇵
Suita-city, Japan
Site Ref # / Investigator 5433
🇯🇵
Shizuoka, Japan
Site Ref # / Investigator 5414
🇯🇵
Shinjuku-ku, Japan
Site Ref # / Investigator 5466
🇯🇵
Suita-city, Japan
Site Ref # / Investigator 5415
🇯🇵
Urayasu, Japan
Site Ref # / Investigator 5481
🇯🇵
Tokushima, Japan
Site Ref # / Investigator 5506
🇯🇵
Tokushima, Japan
Site Ref # / Investigator 5410
🇯🇵
Tokyo, Japan
Site Ref # / Investigator 6918
🇯🇵
Tokushima, Japan
Site Ref # / Investigator 5405
🇯🇵
Tokyo, Japan
Site Ref # / Investigator 5409
🇯🇵
Tokyo, Japan
Site Ref # / Investigator 5412
🇯🇵
Tokyo, Japan
Site Ref # / Investigator 5430
🇯🇵
Tokyo, Japan
Site Ref # / Investigator 5413
🇯🇵
Tokyo, Japan
Site Ref # / Investigator 5468
🇯🇵
Tsu, Japan
Site Ref # / Investigator 6553
🇯🇵
Tokyo, Japan
Site Ref # / Investigator 5475
🇯🇵
Ube-city, Japan
Site Ref # / Investigator 5416
🇯🇵
Yamagata, Japan
Site Ref # / Investigator 5438
🇯🇵
Urayasu, Japan
Site Ref # / Investigator 5403
🇯🇵
Yokohama, Japan
Site Ref # / Investigator 5428
🇯🇵
Yokohama, Japan