NCT00050648

Brief Summary

This study compares the efficacy and analyzes the cellular effects of anti-TAC (Daclizumab) and Cyclosporine in the treatment of psoriasis vulgaris. This is a three-armed study-Daclizumab alone, Cyclosporine alone, and the combination of both Daclizumab and Cyclosporine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 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

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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
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

March 13, 2009

Status Verified

March 1, 2009

Enrollment Period

6.9 years

First QC Date

December 17, 2002

Last Update Submit

March 12, 2009

Conditions

Psoriasis

Keywords

psoriasisDaclizumabCyclosporinanti-TACdermatologyskin

Outcome Measures

Primary Outcomes (1)

  • clinical tolerability of DaclizumabTM and the DaclizumabTM/cyclosporine combination

    day 1, week 1, 2, 3, 4, 5,7,8,9,11, 12, 13, 14

Study Arms (3)

cyclosporine

ACTIVE COMPARATOR

oral medication 2mg/kg/day orally from Day 0 until Day 90

Drug: Cyclosporine

anti-TAC

ACTIVE COMPARATOR

1mg/kg/dose medication every other week on the odd week (week 1-13)

Drug: Daclizumab

Cyclosporine and anti-TAC

EXPERIMENTAL

DaclizumabTM at 1mg/kg plus low dose cyclosporine (2 mg/kg/day)

Drug: cyclosporine and Daclizumab

Interventions

DaclizumabDRUG

1mg/kg medication every other week on the odd week (week 1-13).

anti-TAC
CyclosporineDRUG

2mg/kg/day orally from Day 0 until Day 90 or a total of 13 weeks.

Also known as: Neoral
cyclosporine
cyclosporine and DaclizumabDRUG

1mg/kg plus low dose cyclosporine (2 mg/kg/day)

Cyclosporine and anti-TAC

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 by case basis. Patients below 18 will need parental consent.
  • Extensive skin involvement.
  • Scale, thickness, and erythema in individual psoriasis lesions of at least 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.
  • History of psoriasis that cannot be treated with topical agents or with previous systemic/ photo(chemo)therapy agents.

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. 5.) Major concurrent illness, which could worsen following treatment with DaclizumabTM.
  • \) Any history of an un-treated neoplasm

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

DaclizumabCyclosporine

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptides

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

September 1, 2004

Study Completion

April 1, 2008

Last Updated

March 13, 2009

Record last verified: 2009-03

Locations

US(3)