Trial · NCT00595335

Trial of Rituximab for Graves' Ophthalmopathy

NCT00595335, Phase 2, Phase 3, Completed, Rebecca Bahn; results first posted 2014-06-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Rituximab for Graves' Ophthalmopathy. Trials, record NCT00595335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00595335

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Rituximab for Graves' Ophthalmopathy
NCT number: NCT00595335
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 25 participants, actual
Lead sponsor: Rebecca Bahn
Conditions: Thyroid-associated Ophthalmopathy
Interventions: Rituximab, Saline, Methylprednisolone
First posted: 2008-01-16
Last updated: 2016-01-01
Results first posted: 2014-06-03

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Clinical Activity Score (CAS)	baseline, 6 months after the first infusion	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.
Secondary	Failure Rate	6 months after first infusion, 12 months after first infusion	The failure rate was defined as a composite variable of CAS decrease of \< 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.
Secondary	Change in Disease Severity	baseline, 6 months after first infusion	Disease severity was measured by the NOSPECS Score. This classification scheme of the eye changes in thyroid eye disease was introduced by the American Thyroid Association. It separates patients into seven classes of disease (class 0-6), with 0 being no signs or symptoms and 6 being sight loss. (The acronym is 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) ).
Secondary	Change in Proptosis	baseline, 12 months after first infusion	Eye proptosis is a condition resulting in forward displacement of the globe from its normal position within the orbit. It is measured by computed tomography. Improvement in proptosis was defined as a decrease in proptosis by ≥2 mm.
Secondary	Change in Lid Fissure	baseline, 6 months after first infusion	The palpebral fissure is the elliptic space between the medial and lateral canthi of the two open eye lids. In adults, this measures about 10mm vertically and 30mm horizontally. The fissure may be increased in vertical height in Graves' disease. Improvement was defined as a decrease in lid aperture width by ≥3 mm.
Secondary	Change in Extraocular Motility	baseline, 6 months after first infusion, 12 months after first infusion	Change extraocular motility was assessed using the Gorman diplopia score. Diplopia, commonly known as double vision, is the simultaneous perception of two images of a single object that may be displaced horizontally, vertically, or diagonally (i.e., both vertically and horizontally) in relation to each other. It is usually the result of impaired function of the extraocular muscles, where both eyes are still functional but they cannot converge to target the desired object. The Gorman diplopia score includes four categories: 1) no diplopia (absent), 2) diplopia when the patient is tired or awakening (intermittent), 3) diplopia at extremes of gaze (inconstant), and 4) continuous diplopia in the primary or reading position (constant).
Secondary	Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey	baseline, 6 months after first infusion, 12 months after first infusion	Quality of life (QoL) was measured by the SF-12 questionnaire. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. Physical and Mental Health Composite Scores are computed (combined, scored, and weighted) using the scores of the 12 questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Improvement was defined as a change of ≥ 6 points.
Secondary	Failure Rate at One Year	one year	The failure rate was defined as a composite variable of CAS decrease of \< 2 points or need for additional therapy (excluding cosmetic surgery) for the eye disease.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Clinical Activity Score (CAS)	baseline, 6 months after the first infusion	Sample size was computed based on the expected drop of 2.9 and 1.5 points in the CAS score in rituximab and placebo groups. A sample size of 15 in each group will have 80% power to detect a difference in mean values of 1.4 assuming that the common standard deviation is 1.27 using a two group t-test with a 0.050 two-sided significance level.	units on a scale	MEAN
SECONDARY	Failure Rate	6 months after first infusion, 12 months after first infusion	Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 24 weeks.	percentage of participants	NUMBER
SECONDARY	Change in Disease Severity	baseline, 6 months after first infusion	Intention to treat analysis	participants	NUMBER
SECONDARY	Change in Proptosis	baseline, 12 months after first infusion		mm	MEAN
SECONDARY	Change in Lid Fissure	baseline, 6 months after first infusion	Intention to treat analysis	mm	MEDIAN
SECONDARY	Change in Extraocular Motility	baseline, 6 months after first infusion, 12 months after first infusion	Intention to treat analysis	units on a scale	MEDIAN
SECONDARY	Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey	baseline, 6 months after first infusion, 12 months after first infusion		units on a scale	MEDIAN
SECONDARY	Failure Rate at One Year	one year	Analysis was intent to treat. The last observation was carried forward from the subjects who dropped out before (or at) 52 weeks.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Clinical Activity Score (CAS)	Rituximab		-1.2	Standard Deviation 2	units on a scale
Change in Clinical Activity Score (CAS)	Placebo		-1.5	Standard Deviation 1.8	units on a scale
Failure Rate	Rituximab	Failure rate at 6 months	69		percentage of participants
Failure Rate	Placebo	Failure rate at 6 months	75		percentage of participants
Failure Rate	Rituximab	Failure rate at 12 months	46		percentage of participants
Failure Rate	Placebo	Failure rate at 12 months	50		percentage of participants
Change in Disease Severity	Rituximab	Improvement by 1 class	6		participants
Change in Disease Severity	Placebo	Improvement by 1 class	8		participants
Change in Disease Severity	Rituximab	Improvement by 2 classes	2		participants
Change in Disease Severity	Placebo	Improvement by 2 classes	2		participants

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Baseline to Six Months	STARTED	Rituximab	13
Baseline to Six Months	STARTED	Placebo	12
Baseline to Six Months	COMPLETED	Rituximab	11
Baseline to Six Months	COMPLETED	Placebo	10
Baseline to Six Months	NOT COMPLETED	Rituximab	2
Baseline to Six Months	NOT COMPLETED	Placebo	2
Six Months to Twelve Months	STARTED	Rituximab	11
Six Months to Twelve Months	STARTED	Placebo	10
Six Months to Twelve Months	COMPLETED	Rituximab	10
Six Months to Twelve Months	COMPLETED	Placebo	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Myalgia	Musculoskeletal and connective tissue disorders	Rituximab	0	13	0
other	Myalgia	Musculoskeletal and connective tissue disorders	Placebo	2	12	2
other	Rash on face	Skin and subcutaneous tissue disorders	Rituximab	1	13	1
other	Rash on face	Skin and subcutaneous tissue disorders	Placebo	0	12	0
other	Acute Bronchitis	Respiratory, thoracic and mediastinal disorders	Rituximab	1	13	1
other	Acute Bronchitis	Respiratory, thoracic and mediastinal disorders	Placebo	0	12	0
other	Vasculitis legs	Blood and lymphatic system disorders	Rituximab	1	13	1
other	Vasculitis legs	Blood and lymphatic system disorders	Placebo	0	12	0
other	Significant eye tearing	Eye disorders	Rituximab	1	13	1
other	Significant eye tearing	Eye disorders	Placebo	0	12	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Rituximab
Total, all-cause mortality	Placebo
Total, other adverse events	Rituximab	6	13
Total, other adverse events	Placebo	3	12
Total, serious adverse events	Rituximab	2	13
Total, serious adverse events	Placebo	0	12

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25343233	DERIVED

Source PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
UL1RR024150	Mayo Clinic Center for Translational Science Activities	RIZZA, ROBERT A.	MAYO CLINIC ROCHESTER	NATIONAL CENTER FOR RESEARCH RESOURCES	2006 to 2011	NIH RePORTER
R01DK077814	Thyrotropin Receptor Auto Antibodies in Graves' Ophthalmopathy	BAHN, REBECCA S	MAYO CLINIC ROCHESTER	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2007 to 2010	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Rituximab vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00595335

GET https://conductscience.org/api/trials/v1/NCT00595335/results?page=2

API reference For AI assistants