Trial · NCT00137969
A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
NCT00137969, Phase 2, Phase 3, Completed, Genentech, Inc.; results first posted 2010-12-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus. Trials, record NCT00137969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00137969
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
- NCT number
- NCT00137969
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 262 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Rituximab, Placebo, Prednisone, Acetaminophen, Diphenhydramine
- First posted
- 2005-08-30
- Last updated
- 2019-08-20
- Results first posted
- 2010-12-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period | From baseline to 52 weeks | The BILAG Index measures clinical disease activity in Systemic Lupus Erythematosus (SLE). A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24; PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+\>=2Bs, or\>=2 As, or\>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. |
| Secondary | Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period | From baseline to 52 weeks | The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. The AUCMB of BILAG Score Over 52 Weeks was calculated as: 1. Calculate the AUC of the BILAG global score versus time (in days) by 52 weeks. 2. Calculate the Time-Adjusted AUC by dividing the AUC by the number of days a patient was on the study. 3. Minus the Time-Adjusted AUC by the baseline BILAG global score |
| Secondary | Number of Participants Who Achieved an MCR (Excluding PCR) | From baseline to 52 weeks | The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+\>=2Bs, or\>=2 As, or\>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. |
| Secondary | Number of Participants Who Achieved a PCR (Including MCR) | From baseline to 52 Weeks | The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. PCR = participants who achieved BILAG C score or better at 24 wks and maintained response without a flare for 16 consecutive weeks, or maximum of one BILAG B score at 24 weeks and maintained response without a flare to 52 wks, or maximum of 2 BILAG B scores at 24 wks without development of BILAG scores of A or B until Week 52 if the baseline BILAG score was 1A+\>=2Bs, or\>=2 As, or\>=4 Bs, or participants who enrolled with scores of severe disease and did not achieve a single BILAG B at Month 6. MCR = participants who achieved BILAG C or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. |
| Secondary | Number of Participants Who Achieved a BILAG C or Better in All Domains | 24 weeks | The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. |
| Secondary | Time to First Moderate or Severe Flare | 52 weeks | The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. A severe flare = participants had BILAG A score(s) present in one or more domains or BILAG B scores present in three or more domains at the same visit following a visit of inactive disease state defined above. A moderate flare = participants had only BILAG B scores present in two domains at the same visit following a visit of inactive disease state. |
| Secondary | Change in SLE Expanded Health Survey Physical Function Score From Baseline | From baseline to 52 weeks | Short Form (36) with additional questions specific to lupus (scale = 0-100; with 100 representing the highest level of functioning possible) to measure the ability of rituximab to improve quality of life. A positive value for this outcome measure indicates that symptoms have improved. |
| Secondary | Number of Participants Who Achieved an MCR in The ITT Population | From Weeks 24 to 52 | The BILAG Index measures clinical disease activity in SLE. A single alphabetic score (A through E) is used to denote disease severity for each of the 8 domains. The global BILAG score is the sum of a converted numerical score (A=9, B=3, C=1, D=0, E=0) over 8 domains. MCR = participants who achieved BILAG C scores or better at 24 weeks, maintained this response without developing a flare to 52 weeks, and did not experience a severe flare from Day 1 to Week 24. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period | From baseline to 52 weeks | Intent-to-treat (ITT) population | Participants | NUMBER |
| SECONDARY | Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period | From baseline to 52 weeks | ITT population | BILAG score unit | MEAN |
| SECONDARY | Number of Participants Who Achieved an MCR (Excluding PCR) | From baseline to 52 weeks | ITT population | participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved a PCR (Including MCR) | From baseline to 52 Weeks | ITT population | participants | NUMBER |
| SECONDARY | Number of Participants Who Achieved a BILAG C or Better in All Domains | 24 weeks | ITT population | participants | NUMBER |
| SECONDARY | Time to First Moderate or Severe Flare | 52 weeks | Number of participants who ever reached C/D/E for all 8 BILAG domains before Day 364 visit. If a participant reached C/D/E at the last visit, then this participant was excluded from the analysis. | days | MEDIAN |
| SECONDARY | Change in SLE Expanded Health Survey Physical Function Score From Baseline | From baseline to 52 weeks | ITT population | score on a scale | MEAN |
| SECONDARY | Number of Participants Who Achieved an MCR in The ITT Population | From Weeks 24 to 52 | ITT population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period | Rituximab 1000 mg + Prednisone | MCR (excluding PCR) | 21 | Participants | |
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period | Placebo + Prednisone | MCR (excluding PCR) | 14 | Participants | |
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period | Rituximab 1000 mg + Prednisone | PCR | 29 | Participants | |
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period | Placebo + Prednisone | PCR | 11 | Participants | |
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period | Rituximab 1000 mg + Prednisone | Nonclinical Response (NCR) | 119 | Participants | |
Number of Participants Who Achieved a Major Clinical Response (MCR), Partial Clinical Response (PCR), or Nonclinical Response (NCR) Defined by British Isles Lupus Assessment Group (BILAG) Scores Over The 52-week Treatment Period | Placebo + Prednisone | Nonclinical Response (NCR) | 63 | Participants | |
| Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period | Rituximab 1000 mg + Prednisone | -5.8 | Standard Deviation 4.0 | BILAG score unit | |
| Time-adjusted Area Under The Curve Minus Baseline (AUCMB) of BILAG Score Over The 52-week Treatment Period | Placebo + Prednisone | -5.9 | Standard Deviation 4.5 | BILAG score unit | |
| Number of Participants Who Achieved an MCR (Excluding PCR) | Rituximab 1000 mg + Prednisone | 21 | participants | ||
| Number of Participants Who Achieved an MCR (Excluding PCR) | Placebo + Prednisone | 14 | participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rituximab 1000 mg + Prednisone | 174 | |
| Overall Study | STARTED | Placebo + Prednisone | 88 | |
| Overall Study | Received Study Drug | Rituximab 1000 mg + Prednisone | 169 | |
| Overall Study | Received Study Drug | Placebo + Prednisone | 88 | |
| Overall Study | COMPLETED | Rituximab 1000 mg + Prednisone | 107 | |
| Overall Study | COMPLETED | Placebo + Prednisone | 67 | |
| Overall Study | NOT COMPLETED | Rituximab 1000 mg + Prednisone | 67 | |
| Overall Study | NOT COMPLETED | Placebo + Prednisone | 21 |
Source ClinicalTrials.gov
Adverse events400
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 | Anaemia | Blood and lymphatic system disorders | Rituximab 1000 mg + Prednisone | 6 | 169 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Prednisone | 7 | 88 | |
| other | Tachycardia | Cardiac disorders | Rituximab 1000 mg + Prednisone | 10 | 169 | |
| other | Tachycardia | Cardiac disorders | Placebo + Prednisone | 3 | 88 | |
| other | Palpitations | Cardiac disorders | Rituximab 1000 mg + Prednisone | 9 | 169 | |
| other | Palpitations | Cardiac disorders | Placebo + Prednisone | 3 | 88 | |
| other | Cushingoid | Endocrine disorders | Rituximab 1000 mg + Prednisone | 7 | 169 | |
| other | Cushingoid | Endocrine disorders | Placebo + Prednisone | 6 | 88 | |
| other | Vision Blurred | Eye disorders | Rituximab 1000 mg + Prednisone | 3 | 169 | |
| other | Vision Blurred | Eye disorders | Placebo + Prednisone | 5 | 88 |
1 to 10 of 400Source ClinicalTrials.gov
See all 400 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rituximab 1000 mg + Prednisone | ||
| Total, all-cause mortality | Placebo + Prednisone | ||
| Total, other adverse events | Rituximab 1000 mg + Prednisone | 164 | 169 |
| Total, other adverse events | Placebo + Prednisone | 85 | 88 |
| Total, serious adverse events | Rituximab 1000 mg + Prednisone | 72 | 169 |
| Total, serious adverse events | Placebo + Prednisone | 32 | 88 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20039413 | DERIVED |
Source PubMed
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Rituximab 1000 mg + Prednisone vs Placebo + Prednisone: Number of Participants Who Achieved a PCR (Including MCR) | Trial comparisons |
| Rituximab 1000 mg + Prednisone vs Placebo + Prednisone: Number of Participants Who Achieved an MCR in The ITT Population | Trial comparisons |
| Rituximab 1000 mg + Prednisone vs Placebo + Prednisone: Number of Participants Who Achieved an MCR (Excluding PCR) | Trial comparisons |
| Rituximab 1000 mg + Prednisone vs Placebo + Prednisone: Number of Participants Who Achieved a BILAG C or Better in All Domains | Trial comparisons |
| Rituximab 1000 mg + Prednisone vs Placebo + Prednisone: serious adverse events | Trial comparisons |
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/NCT00137969
GET https://conductscience.org/api/trials/v1/NCT00137969/events?page=2