Discoid lupus erythematosus MedDRA version: 9.1 Level: LLT Classification code 10013072 Term: Discoid lupus erythematosus
Conditions
Interventions
Trade Name: Hydroxychloroquine sulphate - Plaquenil
Pharmaceutical Form: Tablet
Sponsors
The Newcastle upon tyne Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study is describe in full in the attached protocol. We will perform a retrospective study and a prospective study which is described in detail in the attached protocol. For the retrospective study: Patients will be included in the retrospective study if they have clinical and histopathological criteria of discoid lupus erythematosus and have previously taken hydroxychloroquine sulphate (for 3 months or more) as part of their standard management by their responsible dermatologist at their specialist clinic. They need not be on treatment currently. For the prospective study: Patients will be included in the prospective study if they have clinical and histopathological criteria of discoid lupus erythematosus and are about to be started on hydroxychloroquine sulphate as part of their standard management by their responsible dermatologist at their specialist clinic. 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
Exclusion criteria: We will not be including minors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the study is to determine predictors of response to hydroxychloroquine sulphate therapy for discoid lupus erythematosus (DLE). The main objective is to determine whether polymorphisms in the cytochrome P450 (CYP) genes (CYP2C8, CYP2D6) and Ah receptor gene, which encode or interact with the enzymes thought to be responsible for hydroxychloroquine sulphate metabolism in vitro, are related to drug efficacy and/or toxicity in vivo. ;Secondary Objective: To determine, in the context of discoid lupus erythematosus: (a)whether epidermal levels of the cutaneous drug-metabolising enzyme CYP1A1 are correlated with response to hydroxychloroquine sulphate. (b) whether whole blood and epidermal hydroxychloroquine sulphate (and metabolite) levels correlate with response to therapy. (c) whether hydroxychloroquine sulphate efficacy is related to cigarette smoking and cutaneous CYP1A1 levels. ;Primary end point(s): For the retrospective study: Efficacy of hydroxychloroquine sulphate therapy will be determined by reviewing the case notes of participants and assessing response from the medical entries recorded 12 weeks after starting treatment. Response will be categorised as (i) complete clearance; (ii) partial clearance; (iii) no change; (iv) worse. In accordance with the classification used in previous studies, responders will be defined as the total number in groups (i) and (ii) and non-responders as total number in groups (iii) and (iv). We will determine the proportion of responders and non-responders to hydroxychloroquine with polymorphisms in CYP450 and Ah receptor genes. We will also determine whether levels of epidermal CYP1A1 and smoking status is associated with the documented previous response to the drug. For the prospective study: Response to hydroxychloroquine sulphate in discoid lupus erythematosus after 6 months of treatment at standard dose (400mg/day) will be assessed using global assessments of disease and treatment co | — |
Countries
United Kingdom
Outcome results
None listed