Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis)
Conditions
Brief summary
This study will evaluate the safety and efficacy of the combination of rituximab and methotrexate to treat disabling fibrosing skin disorders.Rituximab will be administered at baseline and month 6. The drug will be considered efficacious if the skin thickness diminishes substantially.
Interventions
DRUGRituximab
Mabthera, Rituximab 1000 mg I.V.
Sponsors
University Hospital, Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (Fe) male \>, = 18 years * Fibrosing skin disorder, not fulfilling the ACR criteria for diffuse SSc * Inadequate response to methotrexate (at least 12 weeks 10 mg/w, except if not tolerated or contra-indicated * Debilitating disease defined by either one of the following: * Restriction of mobility * Disfiguration: eg: facial involvement * Severe Internal Organ involvement * Contraception for women with childbearing potential. Sexual abstinence is an alternative to contraception.
Exclusion criteria
* FVC\<, = 50% * LVEF\<, = 40% of predicted value, * DLCO\<, = 40% of predicted value *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Testing the safety of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders. | Safety will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60. |
Secondary
| Measure | Time frame |
|---|---|
| Testing the efficacy of anti-CD-20 in a small cohort of patients with debilitating fibrosing skin disorders. | Efficacy will be evaluated at baseline, month 3, 6, 12, 15, 18, 24, 36, 48 and 60. |
Countries
Belgium
Outcome results
None listed