Phase 4
N=37
Rituximab (RTX) Therapy in Patients With Active TAO
Ophthalmopathy, Thyroid-Associated
Bottom Line
View on ClinicalTrials.gov: NCT02378298 ↗Enrolled (actual)
37
Serious AEs
8.7%
Results posted
Mar 2025
Primary outcome: Primary: Clinical Activity Score (a Composite Measure of Ophthalmological Signs and Symptoms) — 4.25; 2.77; 4.25; 4.20 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rituximab (Drug); Iv Methylprednisolone (Drug); peroral methylprednisolone and Methotrexate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Göteborg University
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Activity Score (a Composite Measure of Ophthalmological Signs and Symptoms) |
4.25; 2.77; 4.25; 4.20; 2.88; 4.00 | — |
Summary
Thyroid Associated Ophthalmopathy is condition affecting the eyes of about 10% of patients with Graves disease. Its combination of protrusion affecting the looks of the patient and pain is often severely affecting the quality of life among these patients.
The standard treatment for this illness today is intravenous glucocorticoids together with methotrexate. The purpose of this study is to evaluate the effect of rituximab on patients that do not respond to or relapse after conventional therapy.
Eligibility Criteria
Inclusion Criteria
- ◦Man or woman between 18-70 years TAO with CAS of ≥ 4 (less than 3 months).
- Euthyroid for at least 6 weeks
Exclusion Criteria
- Dysthyroid optic neuropathy (DON)
- Ulcerative Keratitis
- Previous treatment with steroids for TAO (do not include prophylaxis for TAO in connection with radio iodine treatment)
- Previous Treatment with Rituximab (MabThera®)
- Positive Hepatitis B or C serology.
- Receipt of a live vaccine within 4 weeks prior RTX+MTX to randomization
- History of recurrent significant infection or history of recurrent bacterial infections
- Patient who may not attend to the protocol according to the investigators opinion.
- Pregnancy or lactation
- Significant cardiac, including significant or uncontrolled arrhythmia, or pulmonary disease (including obstructive pulmonary disease).
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- Concomitant malignancies or previous malignancies.
- Previous active tuberculosis
- Alcoholism
- Alcoholic related liver disease or other chronical liver disease
- Bone marrow depression with leukopenia, thrombocytopenia or significant anemia
- Rheumatoid or other significant pulmonary disease
- Allergy to the active substance or any other substance in the medications or murine proteins
- Active, severe infections (such as tuberculosis, sepsis or opportunistic infections)
- Patients with severe immunosuppression
- Severe cardiac failure or severe uncontrolled heart disease
Data sourced from ClinicalTrials.gov (NCT02378298). 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.