Rituximab (RTX) Therapy in Patients With Active TAO

PHASE4CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

September 3, 2019

Study Completion Date

February 1, 2020

Conditions
Ophthalmopathy, Thyroid-Associated
Interventions
DRUG

Rituximab

Rituximab (RTX) is a mouse-human chimeric antibody designed towards (CD20) pre B and mature B lymphocytes and that blocks B-cells activation without affecting the regenerating of B cells from stem cells or the plasma cells immunoglobulin production. Rituximab is used in the treatment of hematologic malignancies (B cells lymphoma, chronic lymphatic leukaemia, Waldenströms macroglobulinemia) and autoimmune diseases with B-cell involvement such as rheumatoid arthritis, thrombocytopenic purpura, SLE).

DRUG

Iv Methylprednisolone

Solumedrol is an intravenous glucocorticoid that are the gold standard in TAO. All patients start with 500 mg/weeks for 4 weeks. The response is evaluated and patients are randomised to non-responders or responders. The responders continues with the gold standard treatment that is another 500 mg solumedrol/ week in 2 weeks and then 250 mg/ week in 6 weeks.

DRUG

peroral methylprednisolone and Methotrexate

Peroral GC (starting with 30 mg and tapering down) is combined with 15-20 mg MTX /week to reduce the needed dose of steroids

Trial Locations (5)

Unknown

Center for Endocrinology and Metabolism, Sahlgrenska University Hospital, Gothenburg

MedTech West, Institute of Neuro Science and Physiology, Department for Clinical Neuro Science and Rehabilitation, Sahlgrenska Academy, University of Gothenburg, Gothenburg

Department of Ophthalmology, Sahlgrenska University Hospital/Mölndal, Mölndal

Department of Rheumatology, Sahlgrenska University Hospital/Mölndal, Mölndal

Department of Radiology, Karolinska University Hospital, Stockholm

All Listed Sponsors
collaborator

Sahlgrenska University Hospital

OTHER

lead

Göteborg University

OTHER

NCT02378298 - Rituximab (RTX) Therapy in Patients With Active TAO | Biotech Hunter | Biotech Hunter