Adalimumab in Adult Japanese Subjects With Psoriasis

April 1, 2011 updated by: Abbott

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

147

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adalimumab 40 mg every other week
Biological: adalimumab
Adalimumab 40 mg every other week, subcutaneous
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
Adalimumab 80 mg every other week, subcutaneous
Other Names:
  • ABT-D2E7
  • Humira
Experimental: Adalimumab 80 mg every other week
Biological: adalimumab
Adalimumab 40 mg every other week, subcutaneous
Other Names:
  • ABT-D2E7
  • Humira
Biological: adalimumab
Adalimumab 80 mg every other week, subcutaneous
Other Names:
  • ABT-D2E7
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a 50% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI50 Response)
Time Frame: 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).
Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With a 75% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI75 Response)
Time Frame: 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).
Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab
Number of Participants With a 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score (PASI90 Response)
Time Frame: 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).
Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Eisai Co., Ltd.
Abbott Japan Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 27, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 31, 2008

Study Record Updates

Last Update Posted (Estimate)

April 8, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M04-702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe