A comparison of the efficacy of oral fumarate and methotrexate therapy in the treatment of severe psoriasis
| ISRCTN | ISRCTN76608307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76608307 |
| Secondary identifying numbers | NL733 (NTR743) |
- Submission date
- 22/11/2006
- Registration date
- 22/11/2006
- Last edited
- 23/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Fallah-Arani
Scientific
Scientific
Erasmus Medical Center
Dermatology Department
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
| Phone | +31 (0)10 4639222 |
|---|---|
| s.fallaharani@erasmusmc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A comparison of the efficacy of oral fumarate and methotrexate therapy in the treatment of severe psoriasis |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fumarate and methotrexate therapy |
| Primary outcome measure | PASI-score |
| Secondary outcome measures | 1. PGA (Physician Global Assessment) 2. Blood and urine samples will be collected for laboratory tests |
| Overall study start date | 01/09/2006 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2006 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Center
Rotterdam
3000 CA
Netherlands
3000 CA
Netherlands
Sponsor information
Erasmus Medical Center (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Dermatology and Venereology
P.O. Box 2040
Rotterdam
3000 CA
Netherlands
"ROR" |
https://ror.org/018906e22 |
|---|
Funders
Funder type
Not defined
Not provided at time of registration
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/12/2010 | 23/09/2021 | Yes | No |
Editorial Notes
23/09/2021: Publication reference added.
