A phase IV open label study in moderate to severe chronic plaque psoriasis subjects transitioning from previous systemic antipsoriasis therapies (methotrexate, cyclosporine, retinoids or PUVA, NBUVB) to Raptiva 1 mg/kg/ week therapy.

A phase IV open label study in moderate to severe chronic plaque psoriasis subjects transitioning from previous systemic antipsoriasis therapies (methotrexate, cyclosporine, retinoids or PUVA, NBUVB) to Raptiva 1 mg/kg/ week therapy. - Open label trial investigating transition from systemic agents to Raptiva.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31969

Enrollment

120

Registered

2008-04-04

Start date

2008-09-26

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

not found

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Mature subjects with moderate to severe chronic plaque-type psoriasis who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including cyclosporine, methotrexate and PUVA and meet all eligibility criteria will be eligible for the study. Subjects must be willing and able to comply with the study requirements and give their written, informed consent.

Exclusion criteria

Exclusion criteria: Subjects who have a contraindication to Raptiva, are participating in another clinical trial (except non-interventional studies, e.g. registries) or are experiencing an acute exacerbation of psoriasis at the time of screening will be excluded.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is safety, and will include all AEs, SAEs, and laboratory data (haematology and biochemistry) and urinalysis at all time points, divided by tapering and previous treatment.	—

Secondary

Measure	Time frame
The secondary endpoint will be the efficacy of Raptiva after 12 weeks therapy, measured as the proportion of subjects who achieve an sPGA assessment of minimal or clear at Week 12 (Day 85). Tertiary endpoints will be the proportion of subjects with >=50% improvement of PASI score and the proportion of subjects with >=75% improvement of PASI score at Week 12 (Day 85) relative to Baseline and the median improvement of DLQI scores at Week 12 (Day 85) relative to Baseline.	—

Measure

Time frame

The secondary endpoint will be the efficacy of Raptiva after 12 weeks therapy, measured as the proportion of subjects who achieve an sPGA assessment of minimal or clear at Week 12 (Day 85). Tertiary endpoints will be the proportion of subjects with >=50% improvement of PASI score and the proportion of subjects with >=75% improvement of PASI score at Week 12 (Day 85) relative to Baseline and the median improvement of DLQI scores at Week 12 (Day 85) relative to Baseline.

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Countries

Netherlands

Outcome results