The objective of this study is to assess the safety and efficacy of efalizumab combined with methotrexate compared with efalizumab monotherapy in adult patients (aged > 18 years) with moderate to severe psoriasis.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for the study is the number and nature of adverse events
in both treatment arms, representing treatment safety.
Secondary outcome
Secondary endpoints are:
· Mean percent reduction in PASI from baseline at week 12
· PASI50, PASI75 and PASI90 response at all visits
· Changes from baseline PASI at all visits
· Mean Skindex and DLQI changes at week 12 and week 24
Background summary
Methotrexate was the first effective systemic drug for psoriasis and still is
the standard systemic therapy for psoriasis. In contrast, efalizumab is one of
the newest systemic treatments for psoriasis. Multiple clinical trials have
been conducted in which the efficacy and safety of efalizumab treatment for
psoriasis was investigated and established.
The safety and efficacy of efalizumab in combination with methotrexate is not
known. Purpose of the study is to treat patients with efalizumab combined with
methotrexate and to compare the safety and efficacy of this treatment with
efalizumab monotherapy.
Study objective
The objective of this study is to assess the safety and efficacy of efalizumab
combined with methotrexate compared with efalizumab monotherapy in adult
patients (aged > 18 years) with moderate to severe psoriasis.
Study design
Patients will be randomized to efalizumab combined with MTX or to efalizumab
monotherapy.
Each visit, Psoriasis Area and Severity Index (PASI) scores are calculated and
adverse events are registered. Furthermore, questionnaires (DLQI, Skindex-29)
are administered.
If PASI reduction is less than 50% at week 12, patients randomized to
efalizumab monotherapy will get combination treatment of efalizumab and MTX.
Patients initially randomized to efalizumab/MTX combination therapy who have
reached a less than 50% reduction in PASI at week 12, will be enabled to
continue this treatment regimen for a maximum of 24 weeks.
Intervention
Efalizumab will be administered subcutaneous (SC), with an initial dose of 0.7
mg/kg/week, followed by 1.0 mg/kg/week. MTX will be administered orally for
preference, as a weekly single dose of 15 mg. In case of intolerance (for
example, gastrointestinal complaints) after oral MTX administration, MTX will
be prescribed as a subcutaneous or intramuscular variant.
MTX dosage can be raised (with a maximum of 25 mg) or lowered according to the
judgment of the physician.
In each visit, blood will be taken by venipuncture for laboratoy analysis.
Study burden and risks
There are no safety data about efalizumab/MTX combination therapy.
Rene Descartesdreef 1
6525 GL Nijmegen
Nederland
Rene Descartesdreef 1
6525 GL Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
- Patients must be older than 18 years of age.
- Patients must have a PASI greater than 10, or a PASI greater than 8 in combination with a Skindex-29 > 35.
- Patients must have failed to respond to phototherapy, methotrexate and/or cyclosporin in the past or have a contraindication for using phototherapy or cyclosporin.
Exclusion criteria
- Patients who have non-plaque forms of psoriasis (eg, erythrodermic, guttate or pustular).
- Patients who have current drug-induced psoriasis.
- Female patients who are pregnant, nursing and both men and women who are planning pregnancy during the study period or during the six months after receiving the last dose of study medication.
- Patients with severe other diseases.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-001630-14-NL |
| CCMO | NL17292.091.07 |