NCT00050661

Brief Summary

This study is designed to study disease relapse after NBUVB and how the administration of Daclizumab/placebo alters disease relapse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 1997

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

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

October 1, 1997

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

6.5 years

First QC Date

December 17, 2002

Last Update Submit

March 24, 2009

Conditions

Psoriasis

Keywords

psoriasisCyclosporineDaclizamubanti-TACdermatologyskinlesions

Outcome Measures

Primary Outcomes (1)

  • time to disease relapse

    After a course of NB-UVB treatment

Secondary Outcomes (1)

  • Histologic assessment of disease activity at relapse for measures of epidermal hyperplasia, leukocyte infiltration, and expression of cytokine-induced inflammatory proteins.

    before and after NB-UVB treatment

Study Arms (2)

Narrow Band Ultraviolet B

ACTIVE COMPARATOR

312nm

Device: NB-UVB

anti-TAC or placebo

EXPERIMENTAL
Drug: Daclizumab

Interventions

DaclizumabDRUG

Humanized anti-CD25 antibodies (anti-TAC), or placebo (saline solution), will be given as intravenous infusions on the following schedule: 2 mg/kg initially (maximum dose 200 mg) infusion given over 60 minutes, followed by a 1 mg/kg (maximum of 100 mg) infusion given over 30 minutes every two weeks thereafter for a total of 8 doses.

Also known as: anti-TAC
anti-TAC or placebo
NB-UVBDEVICE

total body NB-UVB at a dose that is 50% of the MED. Patients are treated 3-7 times per week, with increasing doses at every treatment if no burning occurs. This is continued until for a total of 20 ± 2 treatments total.

Narrow Band Ultraviolet B

Eligibility Criteria

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

You may qualify if:

  • Male or female patients with chronic psoriasis vulgaris (disease stable or worsening for \> 6 months). Patients age 16 - 21 will be considered on a case to case basis.
  • For those patients under the age of 18, parental consent will be obtained.
  • Extensive skin involvement.
  • Scale, thickness, and erythema in individual psoriasis lesions of at least moderate intensity.
  • Psoriasis treated with emollients only for 2 weeks prior to treatment
  • Patients with active psoriatic arthritis, if accompanied by psoriasis vulgaris involving more than 5% of the body surface.
  • Patients that are appropriate for treatment with UVB.

You may not qualify if:

  • Positive serology for HIV, Hepatitis B, or Hepatitis C.
  • Positive β-HCG titer. For women of childbearing potential, unwillingness or inability to use a contraceptive device during this study if negative for β-HCG.
  • Guttate psoriasis, pustular psoriasis, or whole body erythroderma.
  • Active infection or persistent fever of unknown origin.
  • Major concurrent illness, which could worsen following treatment with anti-TAC.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rockefeller University Hospital

New York, New York, 10021, United States

Location

Rockefeller University

New York, New York, 10021, United States

Location

Rockefeller University

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Daclizumab

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 Officials

  • James Krueger, MD, PHD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2002

First Posted

December 18, 2002

Study Start

October 1, 1997

Primary Completion

April 1, 2004

Study Completion

April 1, 2008

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

US(3)