A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab
- Sponsor
- University Hospital, Ghent
- Study ID
- NCT00379431
- Phase
- PHASE2
- Status
- Completed
Conditions
- Early and Severe Systemic Sclerosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Administration of rituximab and methylprednisolone — DRUGRituximab: Pharmaceutical form: Concentrate for solution for infusion. Maximum duration of treatment: 28 weeks Maximum dose allowed: 2000 mg (use of total dose) Route of administration: intravenous use.
Study Details
Rituximab 1000 mg i.v. will be given on day 1 and 15, week 26 - 28, together with a corticosteroid regimen consisting of methylprednisolone 100 mg i.v. 30 minutes prior to both infusions.
Key Dates
- Start date
- Nov 27, 2006
- Status verified
- Dec 2022
- Primary completion
- Feb 2, 2009
- Completion
- Feb 2, 2009
Study Design
- Enrollment
- 9 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Administration of rituximab and methylprednisolone
Primary Outcome Measure
Death [ Time Frame: 28 weeks ]