Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP) (STAR)

• ClinicalTrials.gov Identifier: NCT00799773
• Recruitment Status: Terminated
• First Posted: December 1, 2008
• Results First Posted: July 22, 2013
• Last Update Posted: July 22, 2013
• Sponsor: HealthCore-NERI
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Genentech, Inc.
• Information provided by (Responsible Party): HealthCore-NERI

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Thrombotic Thrombocytopenic Purpura
• Interventions: Drug: Rituximab; Procedure: Plasma exchange; Drug: Corticosteroids
• Enrollment: 3

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Period Title: Overall Study
Started	2	1
Completed	2	1
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Rituximab	Standard of Care	Total
Arm/Group Description		Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.	Total of all reporting groups
Overall Number of Baseline Participants		2	1	3
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants	1 participants	3 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	2 100.0%	1 100.0%	3 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	2 participants	1 participants	3 participants
		43.5 (26.2)	24	37 (22)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants	1 participants	3 participants
	Female	2 100.0%	1 100.0%	3 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	2 participants	1 participants	3 participants
		2	1	3

Outcome Measures

1. Primary Outcome

Title	Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids
Description	[Not Specified]
Time Frame	Measured at Day 52

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

2. Secondary Outcome

Title	Use of Non-study Treatment
Description	[Not Specified]
Time Frame	Measured at Month 36

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

3. Secondary Outcome

Title	Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab
Description	[Not Specified]
Time Frame	Measured at Days 52 and 82

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Relationship Between Clinical and Laboratory Data and Response to Treatment
Description	[Not Specified]
Time Frame	Measured at Days 52 and 82

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

5. Secondary Outcome

Title	Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response
Description	[Not Specified]
Time Frame	Measured at Month 36

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

6. Secondary Outcome

Title	All Cause Mortality
Description	[Not Specified]
Time Frame	Measured at Month 36

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Treatment-related Complications
Description	[Not Specified]
Time Frame	Measured at Day 52

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

8. Secondary Outcome

Title	Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate
Description	[Not Specified]
Time Frame	Measured at Month 36

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

9. Secondary Outcome

Title	Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13
Description	[Not Specified]
Time Frame	Measured at Month 36

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

10. Secondary Outcome

Title	Effect of Plasma Exchange on Rituximab Levels
Description	[Not Specified]
Time Frame	Measured at Month 6

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

11. Secondary Outcome

Title	Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells)
Description	[Not Specified]
Time Frame	Measured at Month 12

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

12. Secondary Outcome

Title	B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not
Description	[Not Specified]
Time Frame	Measured at Month 12

Outcome Measure Data

Analysis Population Description

The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, this subject's data cannot be combined with other subjects' data. Therefore, to protect subject confidentiality, results are not being released for this study.

Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description:	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	The STAR informed consent form told subjects their data would be combined with other subjects' data in study reports. Because one treatment arm included only one subject, to protect subject confidentiality adverse events, though collected, are not being reported for this study.
Arm/Group Title	Rituximab	Standard of Care
Arm/Group Description	Participants will receive rituximab in addition to plasma exchange and corticosteroids.	Participants will receive plasma exchange and corticosteroids.
All-Cause Mortality
	Rituximab	Standard of Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Rituximab	Standard of Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Rituximab	Standard of Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0

Limitations and Caveats

One treatment arm had only one subject, so to protect patient confidentiality, results are not being entered.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Susan F. Assmann, PhD
• Organization: New England Research Institutes, Inc.
• Phone: 617-923-7747 ext 548
• EMail: sassmann@neriscience.com

• Responsible Party: HealthCore-NERI
• ClinicalTrials.gov Identifier: NCT00799773
• Other Study ID Numbers: 558; U01HL072268 ( U.S. NIH Grant/Contract ); HL072268; HL072033; HL072291; HL072196; HL072248; HL072191; HL072305; HL072028; HL072072; HL072355; HL072283; HL072346; HL072331; HL072290
• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Results First Submitted: May 7, 2013
• Results First Posted: July 22, 2013
• Last Update Posted: July 22, 2013