Contact information
Type
Scientific
Primary contact
Misc S Fallah-Arani
ORCID ID
Contact details
Erasmus Medical Center
Dermatology Department
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
+31 (0)10 4639222
s.fallaharani@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Psoriasis is a T-cell mediated skin disease affecting 2 to 3% of the worlds population. Methotrexate is known to be effective in the treatment of severe psoriasis. Like other currently used systemical treatments for psoriasis, methotrexate has a significant potential for toxicity. It can cause bone-marrow toxicity, hepatic fibrosis, stomatitis, gastrointestinal intolerance, fever, alopecia and it is teratogenic.
The anti-psoriatic drug, Fumaderm® or Fumarate '120', further referred to as fumarate therapy or fumarates has proven to be effective in psoriasis vulgaris. Systemic therapy with fumarates may be given to patients for prolonged periods because of its lack of serious side effects. Commonly reported side effects of fumarates are flushing, gastrointestinal complaints, nausea, and tiredness. These side effects usually occur during the induction of fumarate therapy.
This current study is designed to:
1. Determine the efficacy of systemic fumarate and methotrexate therapy.
2. Investigate the advantages of fumarate therapy in comparison with methotrexate therapy.
3. Determine which of the two therapies induce a Psoriasis Area and Severity Index (PASI) reduction of more than or equal to 75 first.
4. Investigate whether the change of PASI-score of patients treated with fumarates or methotrexate is maintained for a long period after cessation of the therapy.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Psoriasis
Intervention
Patients will be randomised to receive either fumarate or methotrexate therapy. The total study-duration will be 16 weeks with a follow-up for four weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
Fumarate and methotrexate therapy
Primary outcome measures
PASI-score
Secondary outcome measures
1. PGA (Physician Global Assessment)
2. Blood and urine samples will be collected for laboratory tests
Overall trial start date
01/09/2006
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients should be at least 18 years with a maximum age of 65 years
2. Patients should suffer from chronic plaque-type psoriasis
3. PASI more than 8
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
60
Participant exclusion criteria
1. Patients with other forms of psoriasis like psoriasis guttata or pustulosa
2. Patients who have received prior treatment with either fumarates or methotrexate
3. Patients in need of co-medications that may influence psoriasis, the clinical response of either fumarates or methotrexate, or toxitcity of either fumarates or methotrexate
4. Acute infections requiring antimicrobial therapy or associated with Human Immunodeficiency Virus (HIV) infection
5. Hepatitis B, C, HIV
6. Pregnancy, breast-feeding, desire to have children within three months after the cessation of therapy, unacceptable or non-compliant contraception
7. Body-weight under 50 kg
8. Obesity (Body mass Index 30 to 40)
9. Relevant cardiovascular, pulmonary, celebral, neurological, hematological, liver or renal impairments
10. (Insulin-dependent) diabetes mellitus
11. Hypertension defined as diastolic pressure higher than 95 mmHg, or a systolic pressure higher than 160 mmHg
12. High risk of liver function disturbances like genetic abnormalities, relevant abnormality in the liver by ultrasound
13. Chronic constrictive heart failure
14. History of arsenic medication, malignancy, carcinogenic therapy, immunosuppressive medication
15. Anemia, leukopenia, thrombocytopenia, high serum creatinin, any blood transfusions
16. Drug or alcohol abuse
Recruitment start date
01/09/2006
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary