Condition category
Skin and Connective Tissue Diseases
Date applied
22/11/2006
Date assigned
22/11/2006
Last edited
11/05/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 world’s 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

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Department of Dermatology and Venereology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes