NCT00646191

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P75+ for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

1.3 years

First QC Date

March 26, 2008

Last Update Submit

March 26, 2008

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Psoriasis Area and Severity Index

    Week 12

  • Adverse Events

    Throughout Study Participation

Secondary Outcomes (3)

  • 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

  • Physician's Global Assessment

    Week 12, 16, 20, 24, 32, 40 and 48

Study Arms (3)

A

ACTIVE COMPARATOR
Drug: adalimumab

B

ACTIVE COMPARATOR
Drug: adalimumab

C

ACTIVE COMPARATOR
Drug: adalimumab

Interventions

adalimumabDRUG

40 mg eow through Week 12 followed by OL 40 mg eow through Week 48, permitted to escalate to weekly dosing upon relapse

Also known as: ABT-D2E7, Humira
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject completed prior PS study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 28, 2008

Study Start

March 1, 2003

Primary Completion

June 1, 2004

Last Updated

March 28, 2008

Record last verified: 2008-03