Phase 3
N=25
Trial of Rituximab for Graves' Ophthalmopathy
Thyroid-associated Ophthalmopathy
Bottom Line
View on ClinicalTrials.gov: NCT00595335 ↗Enrolled (actual)
25
Serious AEs
8.0%
Results posted
Jun 2014
Primary outcome: Primary: Change in Clinical Activity Score (CAS) — -1.2; -1.5 units on a scale — p=0.73
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rituximab (Drug); Saline (Drug); Methylprednisolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rebecca Bahn
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinical Activity Score (CAS) |
-1.2; -1.5 | 0.73 |
| SECONDARY Failure Rate |
69; 75; 46; 50 | 0.75 |
| SECONDARY Change in Disease Severity |
6; 8; 2; 2; 2; 0 | — |
| SECONDARY Change in Proptosis |
0.82; 0.80; 0.1; 0.0 | 0.97 |
| SECONDARY Change in Lid Fissure |
0; 0; 0; 0.5 | 0.98 |
| SECONDARY Change in Extraocular Motility |
3; 2.5; 2; 1.5 | 0.21 |
| SECONDARY Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey |
53.2; 39.9; 44.3; 46.1; 45.9; 40.3 | 0.36 |
| SECONDARY Failure Rate at One Year |
46; 50 | 0.85 |
Summary
This study is being done to investigate the effects (good and bad) of Rituximab for the treatment of an autoimmune eye disease called Graves' ophthalmopathy. This disease has proven to be difficult to treat. Rituximab is a monoclonal antibody that depletes a line of cells involved in the autoimmune response. The study hypotheses is that rituximab is effective in the treatment of patients with moderate to severe active Graves' ophthalmopathy.
Eligibility Criteria
Inclusion Criteria
- Patients with clinical activity score (CAS) of ≥4 and moderate to severe disease severity, as defined by thyroid eye disease severity scale based on the first letter of the defining characteristic of each class, the classification is known as: 'no signs or symptoms; only signs; soft tissue; proptosis; extraocular muscle; cornea; sight loss' (NOSPECS) score
- Euthyroid for at least 6-8 weeks
- No immediate need for decompression surgery
- With disease progression over the previous 1-2 months or without evident improvement in the prior 6 months.
Exclusion Criteria
- Corticosteroid use in the preceding 4 weeks
- HIV, hepatitis C or hepatitis B infections
- Denied consent for HIV or hepatitis testing
- Mild or inactive Graves' ophthalmopathy
- Orbital radiotherapy within 18 months or orbital surgery within the past year
- Absolute neutrophil count < 1,500/mm^3
- Pregnant or nursing patients
- Coronary artery disease, congestive heart failure, significant arrhythmias, significant infection or immunodeficiency, other serious illnesses
Data sourced from ClinicalTrials.gov (NCT00595335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.