Trial · NCT00537290
A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome
NCT00537290, Phase 2, Completed, Hospital for Special Surgery, New York; results first posted 2017-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome. Trials, record NCT00537290. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00537290
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome
- NCT number
- NCT00537290
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Hospital for Special Surgery, New York
- Conditions
- Antiphospholipid Syndrome
- Interventions
- Rituximab
- First posted
- 2007-10-01
- Last updated
- 2017-10-31
- Results first posted
- 2017-10-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Experiencing Serious and Non Serious Adverse Events | 52 weeks + additional 4 months if needed | Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts. |
| Secondary | The Efficacy of Rituximab | 24 weeks | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing Serious and Non Serious Adverse Events | 52 weeks + additional 4 months if needed | All patients enrolled in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Efficacy of Rituximab | 24 weeks | All patients enrolled in the study | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing Serious and Non Serious Adverse Events | Rituximab | 19 | Participants | ||
| The Efficacy of Rituximab | Rituximab | Complete Response | 7 | Participants | |
| The Efficacy of Rituximab | Rituximab | Partial Response | 4 | Participants | |
| The Efficacy of Rituximab | Rituximab | No Response | 6 | Participants | |
| The Efficacy of Rituximab | Rituximab | Could not tolerate the infusion (not evaluated) | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 19 | |
| Overall Study | COMPLETED | Rituximab | 19 | |
| Overall Study | NOT COMPLETED | Rituximab | 0 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Chest pain with fever, chills, and low back pain | Cardiac disorders | Rituximab | 1 | 19 | 2 |
| other | Transient chest pressure | Cardiac disorders | Rituximab | 3 | 19 | 3 |
| other | Diffuse severe erythematous rash | Skin and subcutaneous tissue disorders | Rituximab | 1 | 19 | 1 |
| other | Facial rash | Skin and subcutaneous tissue disorders | Rituximab | 1 | 19 | 1 |
| other | Nausea | Gastrointestinal disorders | Rituximab | 1 | 19 | 1 |
| other | Transient palpitations (recurrence) | Cardiac disorders | Rituximab | 1 | 19 | 1 |
| other | Deep vein thrombosis (recurrence) | Vascular disorders | Rituximab | 1 | 19 | 1 |
| other | Raynaud's phenomenon (new) | Vascular disorders | Rituximab | 1 | 19 | 1 |
| other | Rash (diffuse) within 1 week of rituximab infusion (new) | Skin and subcutaneous tissue disorders | Rituximab | 1 | 19 | 1 |
| other | Rash (local) within 1 week of rituximab infusion (new) | Skin and subcutaneous tissue disorders | Rituximab | 1 | 19 | 1 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab | 0 | 19 |
| Total, other adverse events | Rituximab | 17 | 19 |
| Total, serious adverse events | Rituximab | 12 | 19 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00537290
GET https://conductscience.org/api/trials/v1/NCT00537290/events?page=2