Adalimumab in Adult Japanese Subjects With Psoriasis

NCT ID: NCT00647400

Last Updated: 2011-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2010-04-30

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.

Conditions

Psoriasis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adalimumab 40 mg every other week

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab 40 mg every other week, subcutaneous

Adalimumab 80 mg every other week

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Adalimumab 80 mg every other week, subcutaneous

Interventions

adalimumab

Adalimumab 40 mg every other week, subcutaneous

Intervention Type: BIOLOGICAL

adalimumab

Adalimumab 80 mg every other week, subcutaneous

Intervention Type: BIOLOGICAL

Other Intervention Names

ABT-D2E7; Humira; ABT-D2E7; Humira

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Japan Co.,Ltd

INDUSTRY

Sponsor Role: collaborator

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Kazuko Kobayashi

Role: STUDY_DIRECTOR

Abbott

Locations

Site Ref # / Investigator 5491

Bunkyō City, , 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, , Japan

Site Ref # / Investigator 5406

Fukushima, , Japan

Site Ref # / Investigator 5407

Fukushima, , Japan

Site Ref # / Investigator 5437

Fukushima, , Japan

Site Ref # / Investigator 5401

Gifu, , Japan

Site Ref # / Investigator 5434

Gifu, , Japan

Site Ref # / Investigator 5408

Hamamatsu, , Japan

Site Ref # / Investigator 5495

Hiroshima, , Japan

Site Ref # / Investigator 5391

Hokkaido, , Japan

Site Ref # / Investigator 5402

Ishikawa, , Japan

Site Ref # / Investigator 5431

Itabashi-ku, , 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, , Japan

Site Ref # / Investigator 5499

Kyoto, , Japan

Site Ref # / Investigator 5503

Kyoto, , Japan

Site Ref # / Investigator 5411

Minatoku, , Japan

Site Ref # / Investigator 5404

Mitaka, , Japan

Site Ref # / Investigator 5417

Miyagi, , Japan

Site Ref # / Investigator 5463

Nagasaki, , Japan

Site Ref # / Investigator 5427

Nagoya, , Japan

Site Ref # / Investigator 5465

Nankoku, , Japan

Site Ref # / Investigator 5493

Nankoku, , Japan

Site Ref # / Investigator 5482

Nishinomiya, , Japan

Site Ref # / Investigator 5395

Numakunai, , Japan

Site Ref # / Investigator 5496

Okayama, , Japan

Site Ref # / Investigator 5441

Osaka, , Japan

Site Ref # / Investigator 5467

Osaka, , Japan

Site Ref # / Investigator 5480

Osaka, , Japan

Site Ref # / Investigator 5483

Osaka, , Japan

Site Ref # / Investigator 5498

Osaka, , 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, , Japan

Site Ref # / Investigator 5497

Suita, , Japan

Site Ref # / Investigator 5505

Suita, , 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, , 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

Countries

Japan

Other Identifiers

M04-702

Identifier Type: -

Identifier Source: org_study_id