NCT02378298|CompletedPhase 4ResultsDMC
Rituximab (RTX) Therapy in Patients With Active TAO
Rituximab (RTX) Therapy in Steroid Resistant Patients or Patients Relapsing After Intravenous Steroids With Active TAO
Loading search results
Sponsor study identifier
interventional
38
1 country
5
Study Start
December 2011
Actual (reported)Primary Completion
September 3, 2019
Actual (reported)Study Completion
February 1, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Actual (reported)January 20, 2015
Actual (reported)March 4, 2015
Actual (reported)September 3, 2019
Actual (reported)February 1, 2020
Actual (reported)March 26, 2025
Actual (reported)Clinical Activity Score (a Composite Measure of Ophthalmological Signs and Symptoms)
Clinical activity score (CAS) according to Mouritz et al and the consensus statement from European Group of Graves orbitopathy (EUGOGO). It consists of 10 items (1. Spontaneous retrobulbar pain, 2. Pain on eye movements, 3. Eyelid erythema, 4. Conjunctival injection, 5. Chemosis, 6. Swelling of the caruncle, 7. Eyelid edema or fullness, 8. Change in motility,9. Change in vision acuity,10.Change in proptosis). One point is given to each item, if present. CAS is the sum of single scores, ranging from 0 (no activity) to 10 (maximal activity).
At 4,12,18 and 68 weeks
Thyroid-stimulating Hormone Receptor Antibodies
at 4 weeks
Thyroid-stimulating Hormone Receptor Antibodies
at12 weeks
Thyroid-stimulating Hormone Receptor Antibodies
at18 weeks
Patients with moderate-severe TAO with an inflammatory CAS of ≥ 4 that do not respond to iv GC (deltaCAS \<2 compared to baseline after 4 weeks of iv GC ) or do relapse (deltaCAS ≥2 and total CAS ≥4) after steroid treatment compared to previous CAS measurement at 12 weeks. Rituximab (1000 mg iv with 2 weeks in between) is combined with methotrexate (15-20 mg once a week) to minimize the risk of antibody developement. MTX is always combined with RTX and is never given as a monotherapy in this study. rituximab and methotrexate
Patients that respond to iv GC (Methylprednisolone iv) but relapse after 6 weeks will be randomised to either RTX+MTX or per oral GC (po GC+MTX) rituximab and methotrexate
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).
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
peroral methylprednisolone and Methotrexate
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordCenter for Endocrinology and Metabolism, Sahlgrenska University Hospital
Gothenburg, Sweden
MedTech West, Institute of Neuro Science and Physiology, Department for Clinical Neuro Science and Rehabilitation, Sahlgrenska Academy, University of Gothenburg
Gothenburg, Sweden
Department of Ophthalmology, Sahlgrenska University Hospital/Mölndal
Mölndal, Sweden
Department of Rheumatology, Sahlgrenska University Hospital/Mölndal
Mölndal, Sweden
Department of Radiology, Karolinska University Hospital
Stockholm, Sweden
Helena Filipsson, Ass Prof
Sahlgrenska University Hospital
38 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2015
First Posted
March 4, 2015
Study Start
December 2011
Actual (reported)Use of Botox in the Management of Thyroid Related Upper Eyelid Retraction
Patients that respond to iv GC but relapse after 6 weeks will be randomised to either RTX+MTX or per oral GC (po GC+MTX) This is the conventional therapy arm. methotrexate and methylprednisolone
Patients that respond to iv GC and have no relapse at 18 weeks of study.
All patients in the study have a 4 weeks period of 500 mg methylprednisolone iv/week. Depending of the response patients are classified as non- responders (and are given RTX and MTX) or responders. The responders continue with intravenous infusion of Methylprednisolone 500 mg /week in 2 weeks and thereafter 250 mg iv/week in 6 weeks.
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.
Peroral GC (starting with 30 mg and tapering down) is combined with 15-20 mg MTX /week to reduce the needed dose of steroids
Contact the study team to confirm eligibility.
Primary Completion
September 3, 2019
Actual (reported)Study Completion
February 1, 2020
Actual (reported)Last Updated
March 26, 2025
Results First Posted
March 26, 2025
Record last verified: 2025-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: