Open Label Study of Adalimumab in Subjects Who Have a Sub-Optimal Response to Systemic Therapy or Phototherapy - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00566722

Purpose

To determine the efficacy and safety profile of switching to adalimumab after experiencing a sub-optimal response to prior systemic therapy of etanercept, methotrexate and phototherapy.

Condition	Intervention	Phase
Psoriasis	Biological: adalimumab	Phase III

MedlinePlus related topics: Psoriasis

Drug Information available for: Adalimumab BaseLine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open Label Study of Adalimumab in Subjects Who Have a Sub-Optimal Response to Systemic Therapy or Phototherapy

Further study details as provided by Abbott:

Primary Outcome Measures:

Proportion of subjects who achieve a PGA of clear or minimal at Week 16 [ Time Frame: Screening verse Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject reported outcomes, clinical response indications and safety parameters [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	January 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Open Label: Experimental	Biological: adalimumab Active loading dose at baseline - 80 mg adalimumab active maintenance dose-40 mg EOW

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of chronic plaque psoriasis
Sub-Optimal response to treatment with etanercept, methotrexate, or narrow-band UVB

Exclusion Criteria:

Prior treatment with adalimumab
Multiple concomitant therapy restrictions and/or washouts (topicals, UV, other systemic PS therapies)
Prior treatment with natalizumab
Concurrent active skin diseases/infections
Poorly controlled medical conditions
History of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease.
History of certain cancers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566722

Show 25 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Martin M Okun, M.D., Ph.D.

Abbott

More Information

Responsible Party:	Abbott ( Marie Rosenfeld, CRM )
Study ID Numbers:	M10-238
Study First Received:	December 1, 2007
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00566722
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Adalimumab
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009