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A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome (RITAPS)

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ClinicalTrials.gov Identifier: NCT00537290
Recruitment Status : Completed
First Posted : October 1, 2007
Results First Posted : October 31, 2017
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Antiphospholipid Syndrome
Intervention Drug: Rituximab
Enrollment 19
Recruitment Details Patients who were ≥18 years of age, did not have other systemic autoimmune diseases, and fulfilled at least one of the laboratory criteria and one of the clinical criteria were eligible for inclusion in the study.
Pre-assignment Details Laboratory criteria defined as positive results of a LAC test, positive aCL IgG/IgM/IgA isotype (≥40), and/or positive anti-β2GPI IgG/IgM/IgA isotype (≥40) on 2 or more occasions, at least 12 weeks apart. Clinical criteria defined as 1)persistent thrombocytopenia 2)Cardiovascular disease 3)skin ulcer 4)aPL nephropathy 5) cognitive dysfunction.
Arm/Group Title Rituximab
Hide Arm/Group Description

All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.

Rituximab: Rituximab 1000mg IV on Days 0 and 15

Period Title: Overall Study
Started 19
Completed 19
Not Completed 0
Arm/Group Title Rituximab
Hide Arm/Group Description

All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.

Rituximab: Rituximab 1000mg IV on Days 0 and 15

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
Patients included in the study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
 100.0%
>=65 years
0
   0.0%
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
40.5  (13.8)
[1]
Measure Description: The mean age of the patients
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
11
  57.9%
Male
8
  42.1%
[1]
Measure Description: Gender distribution
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
17
  89.5%
More than one race
0
   0.0%
Unknown or Not Reported
2
  10.5%
[1]
Measure Description: Race distribution
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
 100.0%
[1]
Measure Description: Region of the patients
1.Primary Outcome
Title Number of Participants Experiencing Serious and Non Serious Adverse Events
Hide Description Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts.
Time Frame 52 weeks + additional 4 months if needed
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study.
Arm/Group Title Rituximab
Hide Arm/Group Description:

All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.

Rituximab: Rituximab 1000mg IV on Days 0 and 15

Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
19
 100.0%
2.Secondary Outcome
Title The Efficacy of Rituximab
Hide Description Outcome measures scored as complete response(CR),partial(PR),and none(NR) at 24 weeks.For thrombocytopenia,CR defined as a platelet count of ≥150×109/μl,PR as 100–149,and NR as <100.For CVD,CR defined as the disappearance of cardiac lesions,PR as 50%improvement,and NR as no change.For skin ulcer,CR defined as disappearance,PR as 50% improvement,and NR as no change.For aPL nephropathy,CR defined as a normal serum creatinine level,inactive urinary sediment,and urinary protein:creatinine 0.5;PR as a serum cr level 15%above baseline,RBCs per high-power field 50%above baseline with no casts,50%improvement in the urinary prt:cr,and estimated GFR 10%above baseline;and NR as the absence of C/PR.For cognitive dysfunction,CR defined as normalization of the cognitive impairment index with 50%improvement,PR as abnormal index with 50%,and NR as no change.
Time Frame 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study
Arm/Group Title Rituximab
Hide Arm/Group Description:

All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.

Rituximab: Rituximab 1000mg IV on Days 0 and 15

Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
7
  36.8%
Partial Response
4
  21.1%
No Response
6
  31.6%
Could not tolerate the infusion (not evaluated)
2
  10.5%
Time Frame 52 weeks
Adverse Event Reporting Description An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. A serious adverse event (SAE) was defined as an AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
 
Arm/Group Title Rituximab
Hide Arm/Group Description

All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.

Rituximab: Rituximab 1000mg IV on Days 0 and 15

All-Cause Mortality
Rituximab
Affected / at Risk (%)
Total   0/19 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab
Affected / at Risk (%) # Events
Total   12/19 (63.16%)    
Cardiac disorders   
Multifocal atrial tachycardia due to resolving pneumonia  1 [1]  1/19 (5.26%)  1
Immune system disorders   
Allergy-Trimethoprim/sulfamethoxazole treatment  1 [1]  1/19 (5.26%)  1
Infections and infestations   
Pneumonia  1 [1]  2/19 (10.53%)  2
Viral gastroenteritis/dehydration/cellulitis  1 [1]  1/19 (5.26%)  1
Nervous system disorders   
Antiepileptic drug adjustment (history of seizure disorder)  1 [1]  1/19 (5.26%)  1
Brain surgery (history of seizure disorder)  1 [1]  1/19 (5.26%)  1
Subdural hematoma  1 [1]  1/19 (5.26%)  1
New-onset focal motor seizure due to previous stroke  1 [1]  1/19 (5.26%)  1
48-hour EEG monitoring and new-onset partial sensory seizure  1 [1]  1/19 (5.26%)  1
Vascular disorders   
Recurrent deep vein thrombosis  1 [1]  1/19 (5.26%)  1
Post-phlebitic syndrome  1 [1]  1/19 (5.26%)  1
1
Term from vocabulary, MedDRA 10.0 was used
Indicates events were collected by systematic assessment
[1]
A serious adverse event (SAE) was defined as an adverse event AE meeting ≥1 of the following criteria: death, life-threatening, requiring or prolonging inpatient hospitalization, disabling, or resulting in a congenital anomaly.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rituximab
Affected / at Risk (%) # Events
Total   17/19 (89.47%)    
Blood and lymphatic system disorders   
Epistaxis (recurrence)  1 [1]  1/19 (5.26%)  1
Cardiac disorders   
Chest pain with fever, chills, and low back pain  1 [1]  1/19 (5.26%)  2
Transient chest pressure  1 [1]  3/19 (15.79%)  3
Transient palpitations (recurrence)  1 [1]  1/19 (5.26%)  1
Gastrointestinal disorders   
Nausea  1 [1]  1/19 (5.26%)  1
Gastrointestinal reflux disease (new)  1 [1]  1/19 (5.26%)  1
Infections and infestations   
Upper respiratory tract infection  1 [1]  6/19 (31.58%)  6
Tonsillitis, otitis, sinusitis  1 [1]  3/19 (15.79%)  3
Urinary tract infection  1 [1]  3/19 (15.79%)  3
Bronchitis  1 [1]  2/19 (10.53%)  2
Acute gastroenteritis  1 [1]  2/19 (10.53%)  2
Cellulitis  1 [1]  1/19 (5.26%)  1
Herpes zoster infection within 2 weeks of rituximab infusion (new)  1 [1]  1/19 (5.26%)  1
Herpes zoster infection while noncompliant with prophylaxis (recurrence)  1 [1]  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia (local) (new)  1 [1]  2/19 (10.53%)  2
Arthritis (diffuse) within 1 week of the infusion (new)  1 [1]  2/19 (10.53%)  2
Arthralgia (diffuse) within 2 weeks of the infusion (new)  1 [1]  1/19 (5.26%)  1
Arthralgia (local) (recurrence)  1 [1]  1/19 (5.26%)  1
Carpal tunnel syndrome (recurrence)  1 [1]  1/19 (5.26%)  1
Gout flare (recurrence)  1 [1]  1/19 (5.26%)  1
Shoulder dislocation (new)  1 [1]  1/19 (5.26%)  1
Elbow incidental MRI metallic artifact finding (new)  1 [1]  1/19 (5.26%)  1
Nervous system disorders   
Seizures (history of partially controlled seizures) (recurrence)  1 [1]  1/19 (5.26%)  1
Migraine (new)  1 [1]  1/19 (5.26%)  1
Headache (severe, transient) (new)  1 [1]  1/19 (5.26%)  1
Psychiatric disorders   
Depression (new)  1 [1]  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
Diffuse severe erythematous rash  1 [1]  1/19 (5.26%)  1
Facial rash  1 [1]  1/19 (5.26%)  1
Rash (diffuse) within 1 week of rituximab infusion (new)  1 [1]  1/19 (5.26%)  1
Rash (local) within 1 week of rituximab infusion (new)  1 [1]  1/19 (5.26%)  1
Rash (local) due to nail glue allergy (new)  1 [1]  1/19 (5.26%)  1
Vascular disorders   
Deep vein thrombosis (recurrence)  1 [1]  1/19 (5.26%)  1
Raynaud's phenomenon (new)  1 [1]  1/19 (5.26%)  1
1
Term from vocabulary, MedDRA 10.0 was used
Indicates events were collected by systematic assessment
[1]
An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality.
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: Doruk Erkan, MD
Organization: Hospital for Special Surgery
Phone: 212 774-2291
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT00537290     History of Changes
Other Study ID Numbers: IRB 27022
First Submitted: September 28, 2007
First Posted: October 1, 2007
Results First Submitted: April 20, 2017
Results First Posted: October 31, 2017
Last Update Posted: October 31, 2017