Adalimumab in Adult Japanese Subjects With Psoriasis

NCT00647400 | Completed Phase 2 Results

• 1 other identifier: M04-702
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 64

Brief Summary

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

Conditions

Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

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

  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)

  Baseline and 12, 24, 36, 52, 76, 100, 160, and 208 weeks after the first dose of adalimumab

Study Arms (2)

Adalimumab 40 mg every other week

EXPERIMENTAL

Biological: adalimumab

Adalimumab 80 mg every other week

EXPERIMENTAL

Biological: adalimumab

Interventions

adalimumab BIOLOGICAL

Adalimumab 40 mg every other week, subcutaneous

Also known as: ABT-D2E7, Humira

Adalimumab 40 mg every other week

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participants who completed Study M04-688 (NCT00338754)

You may not qualify if:

• \- Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Sponsors & Collaborators

• Abbott: lead
• Abbott Japan Co.,Ltd: collaborator
• Eisai Co., Ltd.: collaborator

Study Sites (64)

Site Ref # / Investigator 5491

Bunkyō City, Japan

Location

Site Ref # / Investigator 5429

Chiyoda-ku, Japan

Location

Site Ref # / Investigator 5464

Fukuoka, Japan

Location

Site Ref # / Investigator 5477

Fukuoka, Japan

Location

Site Ref # / Investigator 5492

Fukuoka, Japan

Location

Site Ref # / Investigator 5504

Fukuoka, Japan

Location

Site Ref # / Investigator 5400

Fukushima, Japan

Location

Site Ref # / Investigator 5406

Fukushima, Japan

Location

Site Ref # / Investigator 5407

Fukushima, Japan

Location

Site Ref # / Investigator 5437

Fukushima, Japan

Location

Site Ref # / Investigator 5401

Gifu, Japan

Location

Site Ref # / Investigator 5434

Gifu, Japan

Location

Site Ref # / Investigator 5408

Hamamatsu, Japan

Location

Site Ref # / Investigator 5495

Hiroshima, Japan

Location

Site Ref # / Investigator 5391

Hokkaido, Japan

Location

Site Ref # / Investigator 5402

Ishikawa, Japan

Location

Site Ref # / Investigator 5431

Itabashi-ku, Japan

Location

Site Ref # / Investigator 5462

Kagoshima, Japan

Location

Site Ref # / Investigator 5476

Kagoshima, Japan

Location

Site Ref # / Investigator 5435

Kanagawa, Japan

Location

Site Ref # / Investigator 5432

Kawachi-gun, Japan

Location

Site Ref # / Investigator 5440

Kawasaki, Japan

Location

Site Ref # / Investigator 5499

Kyoto, Japan

Location

Site Ref # / Investigator 5503

Kyoto, Japan

Location

Site Ref # / Investigator 5411

Minatoku, Japan

Location

Site Ref # / Investigator 5404

Mitaka, Japan

Location

Site Ref # / Investigator 5417

Miyagi, Japan

Location

Site Ref # / Investigator 5463

Nagasaki, Japan

Location

Site Ref # / Investigator 5427

Nagoya, Japan

Location

Site Ref # / Investigator 5465

Nankoku, Japan

Location

Site Ref # / Investigator 5493

Nankoku, Japan

Location

Site Ref # / Investigator 5482

Nishinomiya, Japan

Location

Site Ref # / Investigator 5395

Numakunai, Japan

Location

Site Ref # / Investigator 5496

Okayama, Japan

Location

Site Ref # / Investigator 5441

Osaka, Japan

Location

Site Ref # / Investigator 5467

Osaka, Japan

Location

Site Ref # / Investigator 5480

Osaka, Japan

Location

Site Ref # / Investigator 5483

Osaka, Japan

Location

Site Ref # / Investigator 5498

Osaka, Japan

Location

Site Ref # / Investigator 5388

Sapporo, Japan

Location

Site Ref # / Investigator 5396

Sapporo, Japan

Location

Site Ref # / Investigator 5399

Sapporo, Japan

Location

Site Ref # / Investigator 5414

Shinjuku-ku, Japan

Location

Site Ref # / Investigator 5433

Shizuoka, Japan

Location

Site Ref # / Investigator 5466

Suita, Japan

Location

Site Ref # / Investigator 5497

Suita, Japan

Location

Site Ref # / Investigator 5505

Suita, Japan

Location

Site Ref # / Investigator 5481

Tokushima, Japan

Location

Site Ref # / Investigator 5506

Tokushima, Japan

Location

Site Ref # / Investigator 6918

Tokushima, Japan

Location

Site Ref # / Investigator 5405

Tokyo, Japan

Location

Site Ref # / Investigator 5409

Tokyo, Japan

Location

Site Ref # / Investigator 5410

Tokyo, Japan

Location

Site Ref # / Investigator 5412

Tokyo, Japan

Location

Site Ref # / Investigator 5413

Tokyo, Japan

Location

Site Ref # / Investigator 5430

Tokyo, Japan

Location

Site Ref # / Investigator 6553

Tokyo, Japan

Location

Site Ref # / Investigator 5468

Tsu, Japan

Location

Site Ref # / Investigator 5475

Ube, Japan

Location

Site Ref # / Investigator 5415

Urayasu, Japan

Location

Site Ref # / Investigator 5438

Urayasu, Japan

Location

Site Ref # / Investigator 5416

Yamagata, Japan

Location

Site Ref # / Investigator 5403

Yokohama, Japan

Location

Site Ref # / Investigator 5428

Yokohama, Japan

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Kazuko Kobayashi

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: March 31, 2008
• Study Start: April 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: April 1, 2010
• Last Updated: April 8, 2011
• Results First Posted: January 11, 2010

Record last verified: 2011-04

Locations

JP (64)