A Phase 2 interventional study of Rituximab in Antiphospholipid Syndrome, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-31.
Sponsored by Hospital for Special Surgery, New York · Phase 2, Interventional, and Treatment
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.
121 studies on the registry are indexed under Antiphospholipid Syndrome; 51 are open to participants now.
This study's enrollment of 19 is below the median of 41 across 64 interventional studies indexed under Antiphospholipid Syndrome.
Browse Antiphospholipid Syndrome studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Positive aPL profile defined as:
AND
Exclusion Criteria (selected):
All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.
Drug: Rituximab
Rituximab 1000mg IV on Days 0 and 15
Also known as: Rituxan
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.
Time frame: 52 weeks + additional 4 months if needed
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.
Time frame: 24 weeks
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.
| Milestone | Rituximab |
|---|---|
| Started | 19 |
| Completed | 19 |
| Not completed | 0 |
Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts.
| Participants | Rituximab |
|---|---|
| Number of Participants Experiencing Serious and Non Serious Adverse Events | 19 |
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.
| Participants | Rituximab |
|---|---|
| Complete Response | 7 |
| Partial Response | 4 |
| No Response | 6 |
| Could not tolerate the infusion (not evaluated) | 2 |
Collected over 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Rituximab | 0/19 (0%) | 12/19 (63.2%) | 17/19 (89.5%) |
| Event | Rituximab |
|---|---|
| PneumoniaInfections and infestations | 2/19 |
| Antiepileptic drug adjustment (history of seizure disorder)Nervous system disorders | 1/19 |
| Brain surgery (history of seizure disorder)Nervous system disorders | 1/19 |
| Subdural hematomaNervous system disorders | 1/19 |
| New-onset focal motor seizure due to previous strokeNervous system disorders | 1/19 |
| 48-hour EEG monitoring and new-onset partial sensory seizureNervous system disorders | 1/19 |
| Viral gastroenteritis/dehydration/cellulitisInfections and infestations | 1/19 |
| Recurrent deep vein thrombosisVascular disorders | 1/19 |
| Post-phlebitic syndromeVascular disorders | 1/19 |
| Multifocal atrial tachycardia due to resolving pneumoniaCardiac disorders | 1/19 |
| Event | Rituximab |
|---|---|
| Upper respiratory tract infectionInfections and infestations | 6/19 |
| Transient chest pressureCardiac disorders | 3/19 |
| Tonsillitis, otitis, sinusitisInfections and infestations | 3/19 |
| Urinary tract infectionInfections and infestations | 3/19 |
| BronchitisInfections and infestations | 2/19 |
| Acute gastroenteritisInfections and infestations | 2/19 |
| Arthralgia (local) (new)Musculoskeletal and connective tissue disorders | 2/19 |
| Arthritis (diffuse) within 1 week of the infusion (new)Musculoskeletal and connective tissue disorders | 2/19 |
| Chest pain with fever, chills, and low back painCardiac disorders | 1/19 |
| Diffuse severe erythematous rashSkin and subcutaneous tissue disorders | 1/19 |
Patients included in the study
| Age, Categorical(Participants) | Rituximab |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 19 |
| >=65 years | 0 |
| Age, Continuous(years) | Rituximab |
|---|---|
| Mean | 40.5 ± 13.8 |
| Sex: Female, Male(Participants) | Rituximab |
|---|---|
| Female | 11 |
| Male | 8 |
| Race (NIH/OMB)(Participants) | Rituximab |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 17 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Region of Enrollment(Participants) | Rituximab |
|---|---|
| United States | 19 |
Plan to share: No
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Hospital for Special Surgery, New York