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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody (aPL) -related certain clinical problems.
Persistently antiphospholipid antibody (aPL)-positive patients, age 18 - 75 years of age, with anticoagulation-resistant manifestations of APS and fulfilling protocol defined study inclusion criteria will receive two doses of Rituximab, and will be followed for 6 and 12 months for clinical and safety outcomes, respectively.
Patients are eligible to take part in this study if their blood test is persistently positive for aPL and they have one or more of the aPL-related clinical problem(s) listed below: low platelet (blood cells involved in the prevention of bleeding) count; anemia (deficiency of red blood cells); heart valve disease; skin ulcers; kidney smal vessel blood clots; and/or memory problems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Rituximab 1000mg IV on Days 0 and 15 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Serious and Non Serious Adverse Events | Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts. | 52 weeks + additional 4 months if needed |
| Measure | Description | Time Frame |
|---|---|---|
| The Efficacy of Rituximab | 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. |
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Inclusion Criteria:
- Positive aPL profile defined as:
AND
- Clinical features attributable to aPL that are resistant to warfarin and/or heparin:
Exclusion Criteria (selected):
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| Name | Affiliation | Role |
|---|---|---|
| Doruk Erkan, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Volcker Center for Women and Rheumatic Disease, Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23124321 | Result | Erkan D, Vega J, Ramon G, Kozora E, Lockshin MD. A pilot open-label phase II trial of rituximab for non-criteria manifestations of antiphospholipid syndrome. Arthritis Rheum. 2013 Feb;65(2):464-71. doi: 10.1002/art.37759. | |
| 22269862 | Derived | Khattri S, Zandman-Goddard G, Peeva E. B-cell directed therapies in antiphospholipid antibody syndrome--new directions based on murine and human data. Autoimmun Rev. 2012 Aug;11(10):717-22. doi: 10.1016/j.autrev.2011.12.011. Epub 2012 Jan 16. |
| Label | URL |
|---|---|
| Hospital for Special Surgery Clinical Trials List | View source |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients included in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Experiencing Serious and Non Serious Adverse Events | Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts. | All patients enrolled in the study. | Posted | Count of Participants | Participants | 52 weeks + additional 4 months if needed |
|
|
52 weeks
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rituximab | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Antiepileptic drug adjustment (history of seizure disorder) | Nervous system disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain with fever, chills, and low back pain | Cardiac disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doruk Erkan, MD | Hospital for Special Surgery | 212 774-2291 | erkand@hss.edu |
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| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 24 weeks |
| Barbara Volcker Center for Women and Rheumatic Disease | View source |
| Participants |
|
| Age, Continuous | The mean age of the patients | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Gender distribution | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race distribution | Count of Participants | Participants |
|
| Region of Enrollment | Region of the patients | Count of Participants | Participants |
|
|
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| Secondary | The Efficacy of Rituximab | 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. | All patients enrolled in the study | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| 0 |
| 19 |
| 12 |
| 19 |
| 17 |
| 19 |
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| Brain surgery (history of seizure disorder) | Nervous system disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| Subdural hematoma | Nervous system disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| New-onset focal motor seizure due to previous stroke | Nervous system disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| 48-hour EEG monitoring and new-onset partial sensory seizure | Nervous system disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| Pneumonia | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| Viral gastroenteritis/dehydration/cellulitis | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| Recurrent deep vein thrombosis | Vascular disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| Post-phlebitic syndrome | Vascular disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| Multifocal atrial tachycardia due to resolving pneumonia | Cardiac disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
| Allergy-Trimethoprim/sulfamethoxazole treatment | Immune system disorders | MedDRA 10.0 was used | Systematic Assessment | 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. |
|
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| Transient chest pressure | Cardiac disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Diffuse severe erythematous rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Facial rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Transient palpitations (recurrence) | Cardiac disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Deep vein thrombosis (recurrence) | Vascular disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Raynaud's phenomenon (new) | Vascular disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Rash (diffuse) within 1 week of rituximab infusion (new) | Skin and subcutaneous tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Rash (local) within 1 week of rituximab infusion (new) | Skin and subcutaneous tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Rash (local) due to nail glue allergy (new) | Skin and subcutaneous tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Gastrointestinal reflux disease (new) | Gastrointestinal disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Epistaxis (recurrence) | Blood and lymphatic system disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Tonsillitis, otitis, sinusitis | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Urinary tract infection | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Bronchitis | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Acute gastroenteritis | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Cellulitis | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Herpes zoster infection within 2 weeks of rituximab infusion (new) | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Herpes zoster infection while noncompliant with prophylaxis (recurrence) | Infections and infestations | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Arthralgia (local) (new) | Musculoskeletal and connective tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Arthritis (diffuse) within 1 week of the infusion (new) | Musculoskeletal and connective tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Arthralgia (diffuse) within 2 weeks of the infusion (new) | Musculoskeletal and connective tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Arthralgia (local) (recurrence) | Musculoskeletal and connective tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Carpal tunnel syndrome (recurrence) | Musculoskeletal and connective tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Gout flare (recurrence) | Musculoskeletal and connective tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Shoulder dislocation (new) | Musculoskeletal and connective tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Elbow incidental MRI metallic artifact finding (new) | Musculoskeletal and connective tissue disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Seizures (history of partially controlled seizures) (recurrence) | Nervous system disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Depression (new) | Psychiatric disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Migraine (new) | Nervous system disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| Headache (severe, transient) (new) | Nervous system disorders | MedDRA 10.0 was used | Systematic Assessment | An adverse event (AE) was defined as any unfavorable medical occurrence, regardless of causality. |
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| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Could not tolerate the infusion (not evaluated) |
|