Adalimumab in Adult Japanese Subjects With Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647400
• Other study ID #: M04-702
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 27, 2008
• Last updated: April 1, 2011
• Start date: April 2006
• Est. completion date: April 2010

Study information

• Verified date: April 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: April 2010
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis

Intervention

Biological:
• adalimumab
Adalimumab 40 mg every other week, subcutaneous
• adalimumab
Adalimumab 80 mg every other week, subcutaneous

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Abbott	Abbott Japan Co.,Ltd, Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)	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).	Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab	No
Secondary	Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)	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).	Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab	No
Secondary	Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)	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).	Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab	No