Rituximab in Systemic Sclerosis

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT01748084
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Days 1 and 15, rituximab 1 gramme plus 100 mg methylprednisolone
  • Placebo (NaCl) — DRUG
    Days 1 and 15, NaCl 500 ml plus 100 mg methylprednisolone

Study Details

The purpose of this study is to determine whether rituximab is effective in the treatment of articular symptoms that occur in systemic sclerosis related polyarthritis

Key Dates

Start date
Apr 9, 2013
Status verified
Oct 2025
Primary completion
Apr 18, 2016
Completion
Apr 18, 2016

Study Design

Enrollment
22 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: NaCl
    NaCl 500 ml IV day 1 and day 15 plus 100 mg methylprednisolone
  • Experimental: Rituximab
    Rituximab 1G IV day 1 and day 15 plus 100 mg methylprednisolone

Primary Outcome Measure

Number of tender and swollen joints [ Time Frame: at 6 months ]

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