Rituximab (RTX) Therapy in Patients With Active TAO

• Status: Active, not recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Göteborg University
• Collaborator: Sahlgrenska University Hospital, Sweden
• Treatments: Methotrexate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Rituximab

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