Trial of Rituximab for Graves' Ophthalmopathy
Phase 2/3 Study of Rituximab for Graves' Ophthalmopathy
3 other identifiers
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2008
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 1, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
June 3, 2014
CompletedJanuary 1, 2016
December 1, 2015
4.9 years
January 1, 2008
March 26, 2014
December 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Clinical Activity Score (CAS)
The clinical activity score (CAS), for Grave's ophthalmopathy has become a widely accepted tool to assess disease activity and help decide the management of the condition. The CAS, which is based on classical signs of inflammation (pain, redness, and swelling), consists of 7 equally weighted items. The total CAS (as used in this study) may range from 0 to 7. The higher the CAS, the greater degree of inflammation is present. A drop in CAS of 2 or more points suggests an improvement in the inflammatory components of the disease. A CAS ≥3 implies active disease.
baseline, 6 months after the first infusion
Secondary Outcomes (7)
Failure Rate
6 months after first infusion, 12 months after first infusion
Change in Disease Severity
baseline, 6 months after first infusion
Change in Proptosis
baseline, 12 months after first infusion
Change in Lid Fissure
baseline, 6 months after first infusion
Change in Extraocular Motility
baseline, 6 months after first infusion, 12 months after first infusion
- +2 more secondary outcomes
Study Arms (2)
Rituximab
EXPERIMENTALRituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Placebo
PLACEBO COMPARATORSubjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Interventions
Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.
Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.
Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Publications (1)
Stan MN, Garrity JA, Carranza Leon BG, Prabin T, Bradley EA, Bahn RS. Randomized controlled trial of rituximab in patients with Graves' orbitopathy. J Clin Endocrinol Metab. 2015 Feb;100(2):432-41. doi: 10.1210/jc.2014-2572. Epub 2014 Oct 24.
PMID: 25343233DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Rebecca S. Bahn
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Rebecca S Bahn, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine, Consultant in Endocrinology, Mayo Clinic
Study Record Dates
First Submitted
January 1, 2008
First Posted
January 16, 2008
Study Start
April 1, 2008
Primary Completion
March 1, 2013
Study Completion
September 1, 2013
Last Updated
January 1, 2016
Results First Posted
June 3, 2014
Record last verified: 2015-12