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Adalimumab in Adult Japanese Subjects With Psoriasis

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis

Intervention: adalimumab (Biological); adalimumab (Biological)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Kazuko Kobayashi, Study Director, Affiliation: Abbott

Summary

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

Clinical Details

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

Primary outcome: Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)

Secondary outcome:

Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)

Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)

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

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

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, Japan

Additional Information

Starting date: April 2006
Last updated: April 1, 2011

Page last updated: August 23, 2015

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