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Trial of Rituximab for Graves' Ophthalmopathy

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ClinicalTrials.gov Identifier: NCT00595335
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : June 3, 2014
Last Update Posted : January 1, 2016
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Rebecca Bahn, Mayo Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Thyroid-associated Ophthalmopathy
Interventions: Drug: Rituximab
Drug: Saline
Drug: Methylprednisolone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rituximab

Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.

Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.

Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion.

Placebo

Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.

Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.


Participant Flow for 2 periods

Period 1:   Baseline to Six Months
    Rituximab   Placebo
STARTED   13   12 
COMPLETED   11   10 
NOT COMPLETED   2   2 
Withdrawal by Subject                0                1 
Disease Progression                1                1 
Adverse Event                1                0 

Period 2:   Six Months to Twelve Months
    Rituximab   Placebo
STARTED   11   10 
COMPLETED   10   9 
NOT COMPLETED   1   1 
Withdrawal by Subject                0                1 
Disease Progression                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rituximab

Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.

Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.

Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion.

Placebo

Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.

Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.

Total Total of all reporting groups

Baseline Measures
   Rituximab   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   12   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.6  (12.7)   61.8  (11.0)   58.6  (11.8) 
Gender 
[Units: Participants]
     
Female   9   8   17 
Male   4   4   8 
Region of Enrollment 
[Units: Participants]
     
United States   13   12   25 
Clinical Activity Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.9  (1.0)   5.3  (1.0)   5.1  (1.0) 
[1] 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.


  Outcome Measures

1.  Primary:   Change in Clinical Activity Score (CAS)   [ Time Frame: baseline, 6 months after the first infusion ]

2.  Secondary:   Failure Rate   [ Time Frame: 6 months after first infusion, 12 months after first infusion ]

3.  Secondary:   Change in Disease Severity   [ Time Frame: baseline, 6 months after first infusion ]

4.  Secondary:   Change in Proptosis   [ Time Frame: baseline, 12 months after first infusion ]

5.  Secondary:   Change in Lid Fissure   [ Time Frame: baseline, 6 months after first infusion ]

6.  Secondary:   Change in Extraocular Motility   [ Time Frame: baseline, 6 months after first infusion, 12 months after first infusion ]

7.  Secondary:   Graves' Ophthalmopathy Quality of Life Score Using the Short Form-12 (SF-12) Health Survey   [ Time Frame: baseline, 6 months after first infusion, 12 months after first infusion ]

8.  Secondary:   Failure Rate at One Year   [ Time Frame: one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Rebecca S. Bahn
Organization: Mayo Clinic
phone: 507-284-2462
e-mail: bahn.rebecca@mayo.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Rebecca Bahn, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00595335     History of Changes
Other Study ID Numbers: 06-006130
R01DK077814-01 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: January 1, 2008
First Posted: January 16, 2008
Results First Submitted: March 26, 2014
Results First Posted: June 3, 2014
Last Update Posted: January 1, 2016