Adalimumab in Adult Japanese Subjects With Psoriasis - Full Text View

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:

MedlinePlus related topics: Psoriasis

Drug Information available for: Adalimumab

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. [ Time Frame: Week 2, Week 4, and then every 4 weeks through Week 40 and at Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of Participants With a 75% and 90% Reduction in PASI (Psoriasis Area and Severity Index) Score Compared With Baseline PASI Score. [ Time Frame: Week 2, Week 4, and then every 4 weeks through Week 40 and at Week 52 ] [ Designated as safety issue: No ]
Incidence of Adverse Events [ Time Frame: Until Approval ] [ Designated as safety issue: Yes ]

Enrollment:	147
Study Start Date:	April 2006
Estimated Study Completion Date:	March 2010
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Adalimumab 40 mg every other week: Experimental	Biological: adalimumab Adalimumab 40 mg every other week, subcutaneous
Adalimumab 80 mg every other week: Experimental	Biological: adalimumab Adalimumab 80 mg every other week, subcutaneous

Eligibility

Criteria

Inclusion Criteria:

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

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Eisai Limited

Investigators

Study Director:

Kazuko Kobayashi

Abbott

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Abbott ( Eiichi Makino )
Study ID Numbers:	M04-702
Study First Received:	March 27, 2008
Results First Received:	December 4, 2009
Last Updated:	January 27, 2010
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 February 08, 2010