Rituximab in the Treatment of Graves' Disease

Sponsor
Odense University Hospital
Study ID
NCT00150111
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Graves´ Disease
  • Thyroid Associated Ophthalmopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methimazole — DRUG
  • Rituximab — DRUG
  • Immunization with various vaccines — BIOLOGICAL

Study Details

Aim: In a phase II pilot study encompassing 20 patients with Graves' disease to evaluate the effect of rituximab: 1\. Biochemically as assessed by markers of disease activity ( free T4, free T3, TSH, TSH-receptor antibodies, anti-TPO)

Key Dates

Start date
Jun 30, 2003
Status verified
Oct 2006
Completion
Oct 31, 2006

Study Design

Enrollment
20 participants
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

Time to relapse after cessation of treatment judged at 1, 3, 6, 9 and 12 months post cessation.

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