Study of the Safety and Efficacy of Adalimumab in Subject... | NCT00646191

Studies
Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT00646191

Sponsor

Abbott

Status

Completed

Last Update Posted

Mar 28, 2008Estimated

Enrollment

137Actual

Phase

Phase 2

Conditions

Psoriasis

Interventions

adalimumab
adalimumab
adalimumab

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Jun 2004Actual

Completion Date

Not provided

First Submitted Date

Mar 26, 2008

First Submission Date that Met QC Criteria

Mar 26, 2008

First Posted Date

Mar 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2008

Last Update Posted Date

Mar 28, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
A	Active Comparator	Drug: adalimumab
B	Active Comparator	Drug: adalimumab
C	Active Comparator	Drug: adalimumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
adalimumab	Drug	40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Psoriasis Area and Severity Index		Week 12
Adverse Events		Throughout Study Participation

Secondary Outcomes

Measure	Description	Time Frame
Psoriasis Area and Severity Index		Week 0, 4, 8, 12, 16, 20, 24, 32, 40 and 48
DLQI, SF-36, Zung Depression Self-Rating Scale, EQ-5D, VAS		Week 12, 24 and 48

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject completed prior PS study

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068879	Adalimumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided