Trial · NCT01382940
A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis
NCT01382940, Phase 4, Completed, Hoffmann-La Roche; results first posted 2014-02-19
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis. Trials, record NCT01382940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01382940
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study on The Safety of Administering Rituximab at A More Rapid Rate in Patients With Rheumatoid Arthritis
- NCT number
- NCT01382940
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 351 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Rheumatoid Arthritis
- Interventions
- rituximab, methotrexate, methylprednisolone, acetaminophen, antihistamine
- First posted
- 2011-06-27
- Last updated
- 2017-08-01
- Results first posted
- 2014-02-19
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion | Within 24 hours of beginning infusion on Day 15 | The primary criterion for assessing safety of the faster infusion was the incidence of infusion related reaction (IRRs). IRRs were adverse events (AEs) that occurred within 24 hours of beginning infusion that were among a pre-specified list of preferred terms from the Medical Dictionary for Regulatory Activities (MedDRA). "Incidence" is defined as the percentage of participants experiencing an IRR. |
| Secondary | Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion | Within 24 hours of beginning infusion on Day 15 | A serious infusion-related reaction (SIRR) is an IRR that meets the definition of a serious adverse event. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution. |
| Secondary | Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion | Within 24 hours of beginning infusion on Day 168 | IRRs are AEs that occurred within 24 hours of beginning infusion that were included on a pre-specified list of MedDRA preferred terms, and an SIRR is an IRR that suggests a significant hazard, contraindication, side effect or precaution. |
| Secondary | Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion | Within 24 hours of beginning infusion on Day 15 | The intensity of AEs were graded on a 5-point scale (Grade 1 to 5) according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0), where Grade 1 indicates "Mild" severity and Grade 5 indicates "Death". The CTCAE defines Grades 3 and 4 as follows: - Grade 3 means "Severe", indicating considerable interference with the patient's daily activities; medical intervention/therapy required; and hospitalization possible. - Grade 4 means "Life-threatening, Disabling", based on extreme limitation in activity; significant medical intervention/therapy required, and hospitalization probable. |
| Secondary | Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion | During the infusion (a 2-hour period) on Day 15 | Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - "Moderate" means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - "Severe" means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study. |
| Secondary | Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion | Within 24 hours of beginning infusion on Day 168 | The intensity of AEs experienced within 24 hours of beginning infusion were graded on NCI's CTCAE (v. 4.0) intensity scale from Grade 1 ("Mild") to Grade 5 ("Death"). Grade 3 AEs are "Severe" and Grade 4 AEs are "Life-threatening, Disabling". |
| Secondary | Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion | During the infusion (a 2-hour period) on Day 168 | Participants who experienced a moderate or serious IRR had their infusion interrupted immediately and received aggressive symptomatic treatment. The CTCAE includes the following severity descriptions: - "Moderate" means mild to moderate interference with the patient's daily activities, no or minimal medical intervention/therapy required; - "Severe" means considerable interference with the patient's daily activities, medical intervention/therapy required, hospitalization possible. If the IRR was moderate, the infusion was not to be restarted before all the symptoms disappeared, and then at half the rate. If the participant tolerated the reduced rate for 30 minutes, the infusion rate was increased to the next rate on the protocol-specified infusion schedule. If the symptoms did not resolve with treatment, the participant was withdrawn from the treatment period of the study. Participants who experienced a severe IRR to rituximab treatment were discontinued from the study. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion | Within 24 hours of beginning infusion on Day 15 | All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion | Within 24 hours of beginning infusion on Day 15 | All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion | Within 24 hours of beginning infusion on Day 168 | All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion | Within 24 hours of beginning infusion on Day 15 | All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion | During the infusion (a 2-hour period) on Day 15 | All randomized participants who received infusion at the faster rate on Day 15. Four participants who received the Day 15 rituximab infusion were excluded from the primary analysis population because their infusion rates could not be determined. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion | Within 24 hours of beginning infusion on Day 168 | All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion | During the infusion (a 2-hour period) on Day 168 | All randomized participants who received infusion at the faster rate on Day 168. One participant received the Day 168 rituximab infusion at the labeled rate rather than at the faster rate and was excluded from the analysis population. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Any Infusion-related Reaction (IRR) Associated With the Second Rituximab Infusion | Rituximab | 6.5 | 95% Confidence Interval 6.5 | percentage of participants | |
| Percentage of Participants Experiencing Any Serious IRR (SIRR) Associated With the Second Rituximab Infusion | Rituximab | 0.0 | 95% Confidence Interval 0.0 to 1.1 | percentage of participants | |
| Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion | Rituximab | Any IRR | 5.9 | 95% Confidence Interval 3.5 to 9.3 | percentage of participants |
| Percentage of Participants Experiencing Any IRR or SIRR Associated With the Third Rituximab Infusion | Rituximab | Any SIRR | 0.0 | 95% Confidence Interval 0.0 to 1.3 | percentage of participants |
| Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Second Rituximab Infusion | Rituximab | 0.6 | 95% Confidence Interval 0.1 to 2.1 | percentage of participants | |
| Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Second Rituximab Infusion | Rituximab | 3.9 | 95% Confidence Interval 2.1 to 6.5 | percentage of participants | |
| Percentage of Participants Experiencing Any Common Toxicity Criteria (CTC) Grade 3 or 4 Adverse Events (AEs) Associated With the Third Rituximab Infusion | Rituximab | 0.0 | 95% Confidence Interval 0.0 to 1.3 | percentage of participants | |
| Percentage of Participants Experiencing the Stopping, Slowing or Interrupting of the Third Rituximab Infusion | Rituximab | 6.6 | 95% Confidence Interval 4.0 to 10.1 | percentage of participants |
Source ClinicalTrials.gov
Participant flow7
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab | 351 | |
| Overall Study | Received Day 1 Infusion | Rituximab | 351 | |
| Overall Study | Received Day 15 Infusions | Rituximab | 341 | |
| Overall Study | Received Day 168 Infusion | Rituximab | 290 | |
| Overall Study | Received Day 182 Infusion | Rituximab | 278 | |
| Overall Study | COMPLETED | Rituximab | 278 | |
| Overall Study | NOT COMPLETED | Rituximab | 73 |
Source ClinicalTrials.gov
Adverse events29
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 | Upper Respiratory Tract Infection | Infections and infestations | Rituximab | 19 | 351 | |
| other | Headache | Nervous system disorders | Rituximab | 20 | 351 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Rituximab | 1 | 351 | |
| serious | Atrial fibrillation | Cardiac disorders | Rituximab | 2 | 351 | |
| serious | Cardiac failure congestive | Cardiac disorders | Rituximab | 1 | 351 | |
| serious | Myocardial infarction | Cardiac disorders | Rituximab | 1 | 351 | |
| serious | Pericardial effusion | Cardiac disorders | Rituximab | 1 | 351 | |
| serious | Deafness neurosensory | Ear and labyrinth disorders | Rituximab | 1 | 351 | |
| serious | Colitis ischaemic | Gastrointestinal disorders | Rituximab | 1 | 351 | |
| serious | Device breakage | General disorders | Rituximab | 1 | 351 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab | ||
| Total, other adverse events | Rituximab | 37 | 351 |
| Total, serious adverse events | Rituximab | 30 | 351 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01382940
GET https://conductscience.org/api/trials/v1/NCT01382940/events?page=2