Adalimumab in Adult Japanese Subjects With Psoriasis

This study has been completed.
Sponsor:
Collaborators:
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00647400
First received: March 27, 2008
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Psoriasis
Biological: adalimumab
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab ] [ Designated as safety issue: No ]
    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).


Enrollment: 147
Study Start Date: April 2006
Study Completion Date: April 2010
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab 40 mg every other week Biological: adalimumab
Adalimumab 40 mg every other week, subcutaneous
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Experimental: Adalimumab 80 mg every other week Biological: adalimumab
Adalimumab 80 mg every other week, subcutaneous
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647400

  Show 64 Study Locations
Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Eisai Co., Ltd.
Investigators
Study Director: Kazuko Kobayashi Abbott
  More Information

No publications provided

Responsible Party: Eiichi Makino, Abbott
ClinicalTrials.gov Identifier: NCT00647400     History of Changes
Other Study ID Numbers: M04-702
Study First Received: March 27, 2008
Results First Received: December 4, 2009
Last Updated: April 1, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Abbott:
Psoriasis

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 14, 2014