Psoriasis Skin and Connective Tissue Diseases
Conditions
Interventions
1. 80 mg loading, then 1 week later, and subsequently 2-weekly throughout the trial, 40 mg adalimumab subcutaneous injections (intervention)
2. Weekly 17.5 mg methotrexate subcutaneous injections (con
Sponsors
Newcastle Clinical Trials Unit
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged = 18 years of age with a diagnosis of moderate chronic plaque psoriasis, as defined by PASI score =5 and <10 2. Able and willing to provide written informed consent 3. Able to self-administer subcutaneous therapy 4. Willing to use effective contraception if woman of childbearing potential
Exclusion criteria
Exclusion criteria: 1. Treatment with methotrexate or adalimumab within 6 months prior to randomisation 2. Prior use of any biologic therapy for psoriasis, psoriatic arthritis, inflammatory bowel disease, or other inflammatory joint diseases 3. Patients who are currently receiving phototherapy, have received phototherapy within the 4 weeks prior to randomisation, or who will require phototherapy during the trial treatment period are excluded. 4. Topical treatment except emollients and mild topical steroids within 2 weeks prior of randomisation* 5. Use of other systemic drugs for the treatment of psoriasis within 12 weeks prior of randomisation* 6. Actively attempting to conceive, are pregnant, or breastfeeding 7. Male participants trying to conceive 8. Co-existing health problems that contraindicate immunosuppression, including tuberculosis (TB), chronic viral infectious diseases, active malignancy 9. Any conditions associated with worsening due to TNF inhibition including multiple sclerosis personal history or in a first-degree relative, personal history of lupus, personal history of moderate or severe heart failure 10. Patients with a significant current neuropsychiatric illness; or any lifetime history of suicidal ideation, suicidal behaviour, or suicide attempts; or are clinically deemed to have an elevated suicide risk by the investigator. *Patients will be allowed to use emollients and mild topical steroids such as hydrocortisone or clobetasone butyrate (Eumovate) throughout trial inclusion. Stronger topical steroids such as betamethasone (including the use of dovobet) or calcineurin antagonists (such as topical tacrolimus or phototherapy) are not permitted. A 2-week washout period will be needed for stronger topical treatments** and 12 weeks for other systemic drugs for PSO. **Tacrolimus ointment 0.1% or 0.03% will be allowed as a rescue medication for facial psoriasis if needed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical end point: The proportion of participants achieving a 75% improvement in their psoriasis area and severity score (PASI 75) at 16 weeks compared to baseline Primary economic end point: Incremental cost per quality-adjusted life year (QALY) gained at 24 weeks, based on EQ-5D-5L collected at baseline, 16 and 24 weeks and Service Use Questionnaire (SUQ) collected at baseline and 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The proportion of participants achieving a 75% improvement in their psoriasis area and severity score (PASI 75), measured using the Psoriasis Area and Severity Index (PASI) score at baseline and 24 weeks 2. The proportion of participants achieving a 90% improvement in their psoriasis area and severity score (PASI 90), measured using the Psoriasis Area and Severity Index (PASI) score at baseline, 16 and 24 weeks 3. The proportion of participants achieving a 100% improvement in their psoriasis area and severity score (PASI 100), measured using the Psoriasis Area and Severity Index (PASI) score at baseline, 16 and 24 weeks 4. PASI score as a continuous variable measured using the Psoriasis Area and Severity Index (PASI) score at baseline, 16 and 24 weeks 5. Proportion of participants achieving absolute PASI measured using the Psoriasis Area and Severity Index (PASI) score at baseline, 16 and 24 weeks 6. Proportion of participants achieving Dermatology Life Quality Index (DLQI) 0 or 1 measured using the Dermatology Life Quality Index (DLQI) score at baseline, 16 and 24 weeks 7. DLQI score as a continuous variable measured using the Dermatology Life Quality Index (DLQI) score at baseline, 16 and 24 weeks 8. Number of participants on trial drug, noted at trial visits at 16 and 24 weeks 9. Number of days on drug, noted at trial visits throughout the trial 10. Overall disease severity and acceptability of interventions measured using the Physician Global Assessment (PGA) for psoriasis score at baseline, 16 and 24 weeks 11. Missed injections at study visits recorded throughout the trial 12. Rates of serious infection, major cardiovascular disease, death, noted at trial visits throughout the trial 13. Average healthcare costs to manage moderate psoriasis patients measured using Service Use Questionnaires (SUQ), EQ-5D-5L and PASI questionnaires at baseline, 16 and 24 weeks 14. Average utility scores: extrapolation of costs and QALYs from data observed during the trial throu | — |
Countries
United Kingdom
Contacts
Public ContactPhilip;Gillian Hampton;Watson
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Outcome results
None listed