Methotrexate in adults with severe atopic dermatitis: a double-blind, randomised, parallel-group, placebo-controlled trial - Methotrexate vs. placebo in adults with severe atopic dermatitis

• Conditions: Severe atopic dermatitis in adults

• Registration Number: EUCTR2005-000871-16-GB
• Lead Sponsor: Dr John Berth-Jones

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Diagnosis of AD according to the revised criteria of Hanifin and Rajka (1980)
2. AD of severity assessed as severe, as defined by the criteria of Rajka and Langland (1989)
3. Aged between 16 and 70 years at the screening visit
4. Consistent use of the same topical corticosteroid for at least 1 month prior to the screening visit
5. Whether male or female, acceptance of need to use effective contraception during heterosexual activity, both during the study period and for 3 months after study medication has been discontinued
6. Finding on screening of:
- liver enzymes within 10% of the upper limit of normal
- normal renal function as assessed by serum creatinine
- normal full blood count or minor abnormality not of medical concern
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known to have liver impairment
2. History of, or currently admit to, high alcohol consumption
3. Known to have renal impairment
4. Suffering from an unexplained haematological abnormality
5. Significant pre-existing immunosuppression from any cause
6. History of malignancy, with the exception of cutaneous basal cell carcinoma
7. Scheduled elective surgical procedure during the trial period
8. Planning to start a family within the trial period or subsequent 3 months, whether male or female
9. In the case of female subjects, are < 8 weeks post partum or breast feeding
10. Suffering from pre-existing pulmonary fibrosis
11. Previous history of intolerance of MTX
12. Use of folate antagonists such as trimethoprim and co-trimoxazole, due to the risk of toxicity
13. Concomitant use of any systemic medication considered by the investigator to be likely to interact with MTX in a clinically significant manner, for example cytotoxic drugs, drugs with clear nephrotoxic or hepatotoxic potential, sulphonamides, pyrimethamine (in some antimalarials), dapsone and phenytoin.
14. Use of the following treatments within the following time limits before study treatment initiation:
- systemic corticosteroids during preceding 2 wks
- ciclosporin during preceding 2 wks
- topical immunosuppressantsduring preceding 4 wks
- PUVA / UVB during preceding 4 wks
- azathioprine during preceding 8 wks
- cytotoxic agents during preceding 8 wks
15. Suffering from active severe systemic infection, including viral hepatitis B or C
16. Likely requirement for vaccination during the course of the study
17. History of past or current substance abuse, psychiatric disease or condition which in the opinion of investigator may invalidate communication with the investigator
18. Any other chronic illness likely to alter the outcome of the study
19. Current participation in another clinical study, or previous participation in one within the preceding 3 months.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: By reference to a group treated only with placebo under double-blind randomised conditions to:<br>1) Evaluate the efficacy of methotrexate in adults with severe atopic dermatitis, as assessed using the six area, six sign atopic dermatitis scoring system<br>2) Describe the safety and tolerability of methotrexate in adults with severe atopic dermatitis, as assessed using patient-reported adverse events and changes in blood results.;Secondary Objective: To assess efficacy using other measurements (investigator global assessment; patient global assessment; visual analogues scores of pruritus, sleep disturbance and disruption of day-time activity; area of skin affected; self-assessed six area, six sign atopic dermatitis; dermatology life quality index; and topical steroid requirement.;Primary end point(s): Efficacy as assessed using the six area, six sign atopic dermatitis scoring system.