NCT00645905

Brief Summary

Study of Two Dosing Schedules 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
148

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
3.1 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

1.8 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-Week 24

  • Adverse Events

    Throughout Study Participation

Secondary Outcomes (2)

  • Psoriasis Area and Severity Index

    Week 12, Week 24 through 360 days after last dose

  • Physician's Global Assessment

    Week 12, Week 24 through 360 days after last dose

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: adalimumab

B

PLACEBO COMPARATOR
Drug: placebo for adalimumab

Interventions

adalimumabDRUG

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

Also known as: ABT-D2E7, Humira
A
placebo for adalimumabDRUG

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

Also known as: placebo
B

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of moderate to severe chronic plaque psoriasis
  • Active psoriasis, despite topical therapies

You may not qualify if:

  • 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

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

June 1, 2003

Primary Completion

March 1, 2005

Last Updated

March 28, 2008

Record last verified: 2008-03