Study of Two Dosing Schedules of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00645905

Purpose

Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis

Condition	Intervention	Phase
Psoriasis	Drug: adalimumab Drug: placebo for adalimumab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	Study of Two Dosing Schedules of Adalimumab in 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:

Psoriasis Area and Severity Index [ Time Frame: Week 12-Week 24 ] [ Designated as safety issue: No ]
Adverse Events [ Time Frame: Throughout Study Participation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Psoriasis Area and Severity Index [ Time Frame: Week 12, Week 24 through 360 days after last dose ] [ Designated as safety issue: No ]
Physician's Global Assessment [ Time Frame: Week 12, Week 24 through 360 days after last dose ] [ Designated as safety issue: No ]

Enrollment:	148
Study Start Date:	June 2003
Primary Completion Date:	March 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: adalimumab OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded 40 mg eow through Week 48, withdrawal and observation for 360 days after last dose
B: Placebo Comparator	Drug: placebo for adalimumab OL 80 mg at Week 0, 40 mg weekly through Week 12, blinded placebo eow through Week 48, withdrawal and observation for 360 days after last dose

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Other active skin diseases or skin infections
Prior exposure to any anti-TNF therapy
Subject has other active skin diseases
Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
Poorly controlled medical conditions
History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease
History of cancer or lymphoproliferative disease
History of active TB or listeriosis, or persistent chronic or active infections
Known to have immune deficiency or is immunocompromised
Clinically significant abnormal laboratory test results
Erythrodermic psoriasis or generalized pustular psoriasis

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Abbott ( Beverly Paperiello / Director, Clinical Program Management )
Study ID Numbers:	M02-538
Study First Received:	March 26, 2008
Last Updated:	March 26, 2008
ClinicalTrials.gov Identifier:	NCT00645905 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Skin Diseases
Psoriasis

Antirheumatic Agents
Adalimumab
Skin Diseases, Papulosquamous

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 September 10, 2009