Clinical trial NCT00647400: Adalimumab in Adult Japanese Subjects With Psoriasis
Official title: A Multicenter Open-Label Continuation Study of the Long-term Safety and Efficacy of Adalimumab (D2E7) in Japanese Subjects With Moderate to Severe Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Abbott Japan Co.,Ltd
name: Eisai Co., Ltd.
First posted: 2008-03-31
Enrollment: 147
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
timeFrame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Secondary outcomes:
measure: Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
timeFrame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
measure: Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
timeFrame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: Site Ref # / Investigator 5491
city: Chiyoda-ku
country: Japan
facility: Site Ref # / Investigator 5429
city: Fukuoka
country: Japan
facility: Site Ref # / Investigator 5464
city: Fukuoka
country: Japan
facility: Site Ref # / Investigator 5477
city: Fukuoka
country: Japan
facility: Site Ref # / Investigator 5492
city: Fukuoka
country: Japan
facility: Site Ref # / Investigator 5504
city: Fukushima-city
country: Japan
facility: Site Ref # / Investigator 5400
city: Fukushima-city
country: Japan
facility: Site Ref # / Investigator 5406
city: Fukushima-city
country: Japan
facility: Site Ref # / Investigator 5407
city: Fukushima-city
country: Japan
facility: Site Ref # / Investigator 5437
city: Gifu
country: Japan
facility: Site Ref # / Investigator 5401
city: Gifu
country: Japan
facility: Site Ref # / Investigator 5434
city: Hamamatsu
country: Japan
facility: Site Ref # / Investigator 5408
city: Hiroshima-city
country: Japan
facility: Site Ref # / Investigator 5495
city: Hokkaido
country: Japan
facility: Site Ref # / Investigator 5391
city: Ishikawa
country: Japan
facility: Site Ref # / Investigator 5402
city: Itabashi-ku
country: Japan
facility: Site Ref # / Investigator 5431
city: Iwate
country: Japan
facility: Site Ref # / Investigator 5395
city: Kagoshima
country: Japan
facility: Site Ref # / Investigator 5462
city: Kagoshima
country: Japan
facility: Site Ref # / Investigator 5476
city: Kanagawa
country: Japan
facility: Site Ref # / Investigator 5435
city: Kawachi-gun
country: Japan
facility: Site Ref # / Investigator 5432
city: Kawasaki-city
country: Japan
facility: Site Ref # / Investigator 5440
city: Kyoto
country: Japan
facility: Site Ref # / Investigator 5499
city: Kyoto
country: Japan
facility: Site Ref # / Investigator 5503
city: Minato-ku
country: Japan
facility: Site Ref # / Investigator 5411
city: Mitaka
country: Japan
facility: Site Ref # / Investigator 5404
city: Miyagi
country: Japan
facility: Site Ref # / Investigator 5417
city: Nagasaki
country: Japan
facility: Site Ref # / Investigator 5463
city: Nagoya-city
country: Japan
facility: Site Ref # / Investigator 5427
city: Nankoku-city
country: Japan
facility: Site Ref # / Investigator 5465
city: Nankoku-city
country: Japan
facility: Site Ref # / Investigator 5493
city: Nishinomiya-city
country: Japan
facility: Site Ref # / Investigator 5482
city: Okayama-city
country: Japan
facility: Site Ref # / Investigator 5496
city: Osaka-city
country: Japan
facility: Site Ref # / Investigator 5441
city: Osaka-city
country: Japan
facility: Site Ref # / Investigator 5467
city: Osaka-city
country: Japan
facility: Site Ref # / Investigator 5480
city: Osaka-city
country: Japan
facility: Site Ref # / Investigator 5483
city: Osaka-city
country: Japan
facility: Site Ref # / Investigator 5498
city: Sapporo
country: Japan
facility: Site Ref # / Investigator 5388
city: Sapporo
country: Japan
facility: Site Ref # / Investigator 5396
city: Sapporo
country: Japan
facility: Site Ref # / Investigator 5399
city: Shinjuku-ku
country: Japan
facility: Site Ref # / Investigator 5414
city: Shizuoka
country: Japan
facility: Site Ref # / Investigator 5433
city: Suita-city
country: Japan
facility: Site Ref # / Investigator 5466
city: Suita-city
country: Japan
facility: Site Ref # / Investigator 5497
city: Suita-city
country: Japan
facility: Site Ref # / Investigator 5505
city: Tokushima
country: Japan
facility: Site Ref # / Investigator 5481
city: Tokushima
country: Japan
facility: Site Ref # / Investigator 5506
city: Tokushima
country: Japan
facility: Site Ref # / Investigator 6918
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 5405
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 5409
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 5410
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 5412
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 5413
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 5430
city: Tokyo
country: Japan
facility: Site Ref # / Investigator 6553
city: Tsu
country: Japan
facility: Site Ref # / Investigator 5468
city: Ube-city
country: Japan
facility: Site Ref # / Investigator 5475
city: Urayasu
country: Japan
facility: Site Ref # / Investigator 5415
city: Urayasu
country: Japan
facility: Site Ref # / Investigator 5438
city: Yamagata
country: Japan
facility: Site Ref # / Investigator 5416
city: Yokohama
country: Japan
facility: Site Ref # / Investigator 5403
city: Yokohama
country: Japan
facility: Site Ref # / Investigator 5428
Study officials:
affiliation: Abbott
name: Kazuko Kobayashi
role: STUDY_DIRECTOR
References: