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Adalimumab in Adult Japanese Subjects With Psoriasis
This study is ongoing, but not recruiting participants.
First Received: March 27, 2008   Last Updated: October 2, 2009   History of Changes
Sponsor: Abbott
Collaborators: Abbott Japan Co.,Ltd
Eisai Limited
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00647400
  Purpose

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


Condition Intervention Phase
Psoriasis
Biological: adalimumab
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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:
  • PASI 50 Response [ Time Frame: Every 4 weeks until Week 40, then every 12 weeks until approval ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PASI 75/90 [ Time Frame: Every 4 weeks until Week 40, then every 12 weeks until approval ] [ Designated as safety issue: No ]
  • Incidence of AEs [ Time Frame: Until Approval ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: April 2006
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Adalimumab 40 mg eow: Experimental Biological: adalimumab
Adalimumab 40 mg eow, sc
Adalimumab 80 mg eow: Experimental Biological: adalimumab
Adalimumab 80 mg eow, sc

  Eligibility

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

Inclusion Criteria:

  • Subjects who completed study M04-688

Exclusion Criteria:

  • Subject 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

Locations
Japan, Metropolis
Tokyo, Metropolis, Japan
Japan, Prefecture
Hokkaido, Prefecture, Japan
Iwate, Prefecture, Japan
Miyagi, Prefecture, Japan
Fukushima, Prefecture, Japan
Tochigi, Prefecture, Japan
Chiba, Prefecture, Japan
Kanagawa, Prefecture, Japan
Ishikawa, Prefecture, Japan
Gifu, Prefecture, Japan
Shizuoka, Prefecture, Japan
Aichi, Prefecture, Japan
Kagoshima, Prefecture, Japan
Kyoto, Prefecture, Japan
Osaka, Prefecture, Japan
Hyogo, Prefecture, Japan
Okayama, Prefecture, Japan
Hiroshima, Prefecture, Japan
Yamaguchi, Prefecture, Japan
Tokushima, Prefecture, Japan
Kochi, Prefecture, Japan
Fukuoka, Prefecture, Japan
Nagasaki, Prefecture, Japan
Mie, Prefecture, Japan
Sponsors and Collaborators
Abbott
Abbott Japan Co.,Ltd
Eisai Limited
Investigators
Study Director: Kazuko Kobayashi Abbott
  More Information

No publications provided

Responsible Party: Abbott ( Eiichi Makino )
Study ID Numbers: M04-702
Study First Received: March 27, 2008
Last Updated: October 2, 2009
ClinicalTrials.gov Identifier: NCT00647400     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 27, 2009