Trial · NCT00626197
A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
NCT00626197, Phase 3, Terminated, Genentech, Inc.; results first posted 2020-12-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG). Trials, record NCT00626197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00626197
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG)
- NCT number
- NCT00626197
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 381 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Lupus Nephritis, Systemic Lupus Erythematosus
- Interventions
- Corticosteroids, Cyclophosphamide, Mycophenolate Mofetil, Ocrelizumab, Placebo, Azathioprine
- First posted
- 2008-02-29
- Last updated
- 2020-12-22
- Results first posted
- 2020-12-22
- Limitations and caveats
The study was terminated early due to an imbalance in serious infections in ocrelizumab-treated participants versus placebo-treated participants. Only 139 of the 381 participants randomized completed the 48 week treatment period.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Achieved Complete Renal Response (CRR) | Week 48 | CRR was defined as: 1. Normal serum creatinine (and with no more than a 25 percent \[%\] increase from Baseline); 2. Improvement in urinary protein:urinary creatinine ratio to less than or equal to (≤) 0.5. PRR was defined as at least 50 percent (%) reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio was greater than (\>) 3, a urine protein:urine creatinine ratio of less than (\<) 3 needed to be achieved. |
| Primary | Percentage of Participants Who Achieved Overall Response | Week 48 | Overall response rate (ORR) equals (=) CRR + PRR. CRR was defined as: 1. Normal serum creatinine (and with no more than a 25% increase from baseline) 2. Improvement in urinary protein:urinary creatinine ratio to ≤0.5. PRR was defined as at least 50 % reduction in proteinuria from Baseline, without more than 25% increase of serum creatinine at Week 48, compared with Baseline. If Baseline urine protein:urine creatinine ratio is \>3, a urine protein:urine creatinine ratio of \<3 needs to be achieved. |
| Secondary | Percentage of Participants Who Achieved a Renal Response (Partial or Complete) by Week 36, and Sustain or Improve This Response Until Week 48 | Weeks 36, 40, 44, and 48 | |
| Secondary | Time To Complete Renal Response | Baseline up to Week 48 | Time to complete renal response was proposed to be analyzed using a stratified log rank test with race and SOC as stratification factors. Comparisons of ocrelizumab versus placebo were to be expressed as p-values, estimated hazard ratios, adjusted proportions of participants who achieved a complete renal response and their 95% confidence intervals. Kaplan-Meier curves were to be produced. Due to early termination of the study the analyses were not performed. |
| Secondary | Area Under the Curve (AUC) of Calculated Glomerular Filtration Rate (cGFR) Between Baseline and Week 48 | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48 | The improvement of AUC of cGFR was to be measured between Baseline and Week 48. This was to be analyzed with Analysis of Covariance (ANCOVA) with race and SOC as covariates. |
| Secondary | Percentage of Participants Who Achieved A Reduction In Systemic Lupus Erythematosis Disease Activity Index (SLEDAI) -2K Score | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | SLEDAI-2K measures disease activity at the visit or within the preceding 10 days. It comprised of 24 descriptors, covering 9 organ systems, and reflects disease activity over the previous 10 days.The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity |
| Secondary | Time to First Renal Flare In Those Participants Who Demonstrated at Least a Partial Renal Response | Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Renal flares may be either proteinuric or nephritic as defined below: Proteinuric Flares are defined as follows:In participants who achieve a urine protein:urine creatinine (Upr:Ucr) ≤ 0.5, an increase to Upr:Ucr \>1; In participants with an Upr:Ucr \>0.5, a doubling of Upr:Ucr (with a minimum increase to Upr:Ucr \>2). Nephritic Flare defined as: Increase in serum creatinine of ≥30% from the lowest value achieved in the study accompanied by Increase Upr:Ucr \>1 Or New/worsening active urine sediment on two consecutive occasions, in the absence of urinary tract infection or other causes of hematuria. |
| Secondary | Percentage of Participants Who Achieved Clinically Meaningful Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF36) From Baseline to Week 48 | Baseline and Weeks 1, 12, 24, 36, and 48 | The SF36 Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale. A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions physical role functioning, emotional role functioning, social role functioning, and mental health. |
| Secondary | Percentage of Participants Who Achieved Clinically Meaningful Improvement in Fatigue Using the Functional Assessment of Chronic Illness Therapy (Facit) Fatigue Questionnaire From Baseline to Week 48 | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | The FACIT Fatigue Scale is a short, 13-item, easy-to-administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). |
| Secondary | Percentage of Participants Who Achieved Clinically Meaningful Improvement in Pain Using the Modified Brief Pain Inventory Short Form (mBPI-SF) From Baseline to Week 48 | Baseline and Weeks 1, 12, 24, 36, and 48 | m-BPI-sf is a self-administered 11-point Likert rating scale to rate pain in the past 24 hours. A single item pertains to worst pain in the past 24 hours with a range of 0 (no pain) to 10 (worst imaginable pain). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 Complete Renal Response (CRR) | Week 48 | The primary endpoint was analyzed via an overall response (CRR+PRR) analysis and the separate complete and partial response rates were only summarized descriptively | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved Overall Response | Week 48 | The primary endpoint was analyzed via an overall response (CRR+PRR) analysis and the separate complete and partial response rates were only summarized descriptively | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Renal Response (Partial or Complete) by Week 36, and Sustain or Improve This Response Until Week 48 | Weeks 36, 40, 44, and 48 | Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data. | ||
| SECONDARY | Time To Complete Renal Response | Baseline up to Week 48 | Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data. | ||
| SECONDARY | Area Under the Curve (AUC) of Calculated Glomerular Filtration Rate (cGFR) Between Baseline and Week 48 | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48 | Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed. | ||
| SECONDARY | Percentage of Participants Who Achieved A Reduction In Systemic Lupus Erythematosis Disease Activity Index (SLEDAI) -2K Score | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed. | ||
| SECONDARY | Time to First Renal Flare In Those Participants Who Demonstrated at Least a Partial Renal Response | Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Efficacy date were summarized in the primary endpoints and due to early study termination the protocol was modified to transition the participants into the safety follow-up period. Additional efficacy outcome measures were not analyzed and study results focus on the full summary of safety data. | ||
| SECONDARY | Percentage of Participants Who Achieved Clinically Meaningful Improvement in the Physical and Mental Component Scores of the Short Form 36 (SF36) From Baseline to Week 48 | Baseline and Weeks 1, 12, 24, 36, and 48 | Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed. | ||
| SECONDARY | Percentage of Participants Who Achieved Clinically Meaningful Improvement in Fatigue Using the Functional Assessment of Chronic Illness Therapy (Facit) Fatigue Questionnaire From Baseline to Week 48 | Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 | Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed. | ||
| SECONDARY | Percentage of Participants Who Achieved Clinically Meaningful Improvement in Pain Using the Modified Brief Pain Inventory Short Form (mBPI-SF) From Baseline to Week 48 | Baseline and Weeks 1, 12, 24, 36, and 48 | Due to the early termination and unblinding of the study, no data was collected for this endpoint and analysis was not performed. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group345
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 Complete Renal Response (CRR) | OCR 400 mg + SOC | CRR | 42.7 | Percentage of Participants | |
| Number of Participants Who Achieved Complete Renal Response (CRR) | OCR 1000 mg + SOC | CRR | 31.5 | Percentage of Participants | |
| Number of Participants Who Achieved Complete Renal Response (CRR) | Placebo + SOC | CRR | 34.7 | Percentage of Participants | |
| Number of Participants Who Achieved Complete Renal Response (CRR) | OCR 400 mg + SOC | PRR | 24 | Percentage of Participants | |
| Number of Participants Who Achieved Complete Renal Response (CRR) | OCR 1000 mg + SOC | PRR | 35.6 | Percentage of Participants | |
| Number of Participants Who Achieved Complete Renal Response (CRR) | Placebo + SOC | PRR | 20 | Percentage of Participants | |
| Percentage of Participants Who Achieved Overall Response | OCR 400 mg + SOC | 66.7 | 95% Confidence Interval 56 to 77.3 | Percentage of Participants | |
| Percentage of Participants Who Achieved Overall Response | OCR 1000 mg + SOC | 67.1 | 95% Confidence Interval 56.3 to 77.9 | Percentage of Participants | |
| Percentage of Participants Who Achieved Overall Response | Placebo + SOC | 54.7 | 95% Confidence Interval 43.4 to 65.9 | Percentage of Participants | |
| Mean Absolute Counts of Cluster of Differentiation (CD) 19 Positive (+) Cells Per Visit | Placebo + SOC | Baseline | 203.5 | Standard Deviation 191.4 | Cells/uL |
1 to 10 of 345Source ClinicalTrials.gov
See all 345 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | OCR 400 mg + SOC | 127 | |
| Overall Study | STARTED | OCR 1000 mg + SOC | 128 | |
| Overall Study | STARTED | Placebo + SOC | 126 | |
| Overall Study | COMPLETED | OCR 400 mg + SOC | 83 | |
| Overall Study | COMPLETED | OCR 1000 mg + SOC | 74 | |
| Overall Study | COMPLETED | Placebo + SOC | 49 | |
| Overall Study | NOT COMPLETED | OCR 400 mg + SOC | 44 | |
| Overall Study | NOT COMPLETED | OCR 1000 mg + SOC | 54 | |
| Overall Study | NOT COMPLETED | Placebo + SOC | 77 |
Source ClinicalTrials.gov
Adverse events486
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 | Hypertension | Vascular disorders | Placebo + SOC | 7 | 125 | 8 |
| other | Hypertension | Vascular disorders | OCR 1000 mg + SOC | 12 | 127 | 15 |
| other | Hypertension | Vascular disorders | OCR 400 mg + SOC | 12 | 126 | 19 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | Placebo + SOC | 11 | 125 | 12 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | OCR 1000 mg + SOC | 17 | 127 | 19 |
| other | Infusion related reaction | Injury, poisoning and procedural complications | OCR 400 mg + SOC | 14 | 126 | 18 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo + SOC | 7 | 125 | 8 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | OCR 1000 mg + SOC | 4 | 127 | 5 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | OCR 400 mg + SOC | 11 | 126 | 12 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + SOC | 5 | 125 | 5 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo + SOC | 6 | 125 |
| Total, all-cause mortality | OCR 1000 mg + SOC | 6 | 127 |
| Total, all-cause mortality | OCR 400 mg + SOC | 3 | 126 |
| Total, other adverse events | Placebo + SOC | 96 | 125 |
| Total, other adverse events | OCR 1000 mg + SOC | 91 | 127 |
| Total, other adverse events | OCR 400 mg + SOC | 101 | 126 |
| Total, serious adverse events | Placebo + SOC | 36 | 125 |
| Total, serious adverse events | OCR 1000 mg + SOC | 38 | 127 |
| Total, serious adverse events | OCR 400 mg + SOC | 53 | 126 |
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
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