Trial · NCT01714817
Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
NCT01714817, Phase 3, Terminated, Bristol-Myers Squibb; results first posted 2017-12-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis. Trials, record NCT01714817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01714817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
- NCT number
- NCT01714817
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 695 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Lupus Nephritis
- Interventions
- BMS-188667, Mycophenolate mofetil, Prednisone, Placebo matching with BMS-188667
- First posted
- 2012-10-26
- Last updated
- 2021-02-26
- Other registries' IDs
- eudract:2012-000714-11
- Results first posted
- 2017-12-21
- Limitations and caveats
Study terminated early after review of Year 1 data. Only Year 2/LTE data captured within blind was analyzed. Outcomes related to renal responses were not calculated due to lack of data caused by the early termination.
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period | Day 365 | Number of participants achieving CR was divided by the total number of participants in that arm and expressed as a percentage. CR defined as: eGFR is normal or no \<85% of the baseline; eGFR based on mean creatinine value from day 358 and 365. Proteinuria: UPCR\<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no \>10 mg prednisone or equiv. for at least 28 days prior to assessment. Participants with \>10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as having achieved CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use (Yes/No), race (Asian/ Black/Caucasian/Other) and baseline UPCR as a continuous variable. |
| Secondary | Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period | Day 365 | Number of participants achieving CR was divided by total participants in that arm, expressed as a percentage. CR is defined the following criteria: eGFR is normal or no \<85% of the baseline value; eGFR is based on mean creatinine value from day 358 and 365. Proteinuria: UPCR\<0.5 mg/mg. Urine sediment: No cellular casts. Corticosteroid dose: Daily dose must be no \>10 mg prednisone or equivalent for at least 28 days prior. Subjects with \>10mg/day prednisone or equivalent for non-renal disease within 28 days prior to day 365 will be imputed as CR if the following are true: Met all criteria for CR at day 337 and all criteria for CR except corticosteroid dose at day 365; Investigator confirms increase in steroid dose is not related to renal disease. Adjusted odds ratio is estimated from logistic regression model which includes treatment group, baseline ACEi/ARBs use, race and baseline UPCR as a continuous variable. |
| Secondary | Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants | Baseline and Day 365 | Adjusted Mean Change from Baseline in UPCR at Day 365 of the double-blind period in nephrotic participants |
| Secondary | Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population | Day 1 and Day 365 | Adjusted Mean Change from Baseline in Urine protein/creatinine ratio (UPCR) at Day 365 of the double-blind period in the overall population |
| Secondary | Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period | Day 1 to Day 365 | Adjusted mean change from baseline in British Isles Lupus Assessment Group (BILAG) score over time during Year 1 of the double-blind period based on a repeated measure mixed model and presented at each visit in the first 12-month of the double-blind period. BILAG index measures disease activity in different organs/systems separately. BILAG score is calculated for each of 9 systems depending on the clinical features present and whether they are new (4 points), worse (3 points), the same (2 points), improving (1 point) or not present (0 points) in the last 4 weeks compared with previously. BILAG "A" represents the presence of serious features of lupus. BILAG "B" represents more moderate features of the disease. BILAG "C" includes only mild symptomatic features. BILAG "D" represents prior activity with no current symptoms due to active lupus. BILAG "E" represents an organ that has never been involved. Overall BILAG score ranges from 0-108, with higher scores reflecting a worse outcome. |
| Secondary | Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period | From Day 1 up to 56 days post last dose in Year 1 of the double-blind period | All AEs were coded and grouped into preferred terms (PT) by system organ class (SOC), using the Medical Dictionary for Regulatory Activities (MedDRA, version 21.0). Investigators determined the intensity of each AE as mild, moderate, severe, or very severe and assessed the relationship to study drug. |
| Secondary | Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period | Day 365, Day 729 | Complete Renal Response or Complete Response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; UPCR \< 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. Partial Renal Response or Partial Response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR \< 0.5 OR 50% reduced from baseline and \< 1 if baseline value was \< 3, OR 50% reduced from baseline and \< 3 if baseline value was greater than or equal to 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment. No Renal Response or No Response (NR): defined as not meeting criteria for CR or PR or withdrawn |
| Secondary | Median Time to Complete Renal Response During the Double-blind Period in All Participants | Day 365, Day 729 | The estimate of median time to Complete Renal Response is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) \< 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. |
| Secondary | Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants | Day 365, Day 729 | The estimate of median time to Complete Renal Response in nephrotic participants is based on Kaplan-Meier analysis. Complete renal response (CR): defined as meeting ALL of the following criteria: eGFR normal OR no less than 85% of the baseline value; Urine protein/creatinine ratio (UPCR) \< 0.5; Urine sediment: No cellular casts; Daily corticosteroid dose must be no greater than 10 mg prednisone or equivalent for at least 28 days prior to assessment. |
| Secondary | Median Time to Partial Renal Response During the Double-blind Period in All Participants | Day 365, Day 729 | The estimate of median time to Partial Response (PR) is based on Kaplan-Meier analysis. Partial renal response (PR): defined as meeting ALL of the following criteria: Participant does not meet criteria for CR; eGFR no less than 85% of the lesser of the values at screening or randomization (Day 1); UPCR \< 0.5 OR 50% reduced from baseline and \< 1 if baseline value was \< 3, OR 50% reduced from baseline and \< 3 if baseline value was 3; Urine sediment: no cellular casts; daily corticosteroid dose no greater than 10 mg/day prednisone or prednisone equivalent for at least 28 days prior to assessment |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period | Day 365 | All randomized and treated participants | Percentage | NUMBER |
| SECONDARY | Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period | Day 365 | All randomized and treated nephrotic participants. Nephrotic is defined as screening UPCR \>= 3.0mg/mg (\>=339mg/mmol) | Percentage | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants | Baseline and Day 365 | All randomized and treated nephrotic participants with both post-baseline and baseline measurements | UPCR (mg/mg) | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population | Day 1 and Day 365 | All randomized and treated participants with both post-baseline and baseline measurements | UPCR (mg/mg) | MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period | Day 1 to Day 365 | All randomized and treated participants with both post-baseline and baseline measurements | Scores on a Scale | MEAN |
| SECONDARY | Number of Participants With Any Adverse Events (AEs) During Year 1 of the Double-blind Period | From Day 1 up to 56 days post last dose in Year 1 of the double-blind period | All treated participants | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Ranked Outcome of Complete Renal Response, Partial Renal Response (PR), and No Renal Response (NR) During the Double-blind Period | Day 365, Day 729 | All randomized and treated participants.~Year 1 data based on all elements of clinical response definition: UPCR, eGFR and cellular casts.~Study terminated and Year 2 data based on only two clinical response definition elements: UPCR and eGFR. Data presented for the as observed population (those that completed Day 729). | Percentage | NUMBER |
| SECONDARY | Median Time to Complete Renal Response During the Double-blind Period in All Participants | Day 365, Day 729 | All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only) | Days | MEDIAN |
| SECONDARY | Median Time to Complete Renal Response During the Double-blind Period in Nephrotic Participants | Day 365, Day 729 | All randomized and treated nephrotic participants, as observed, calculated per modified criteria (UPCR and eGFR only); Nephrotic is defined as screening UPCR \>= 3.0 mg/mg (\>=339mg/mmol) | Days | MEDIAN |
| SECONDARY | Median Time to Partial Renal Response During the Double-blind Period in All Participants | Day 365, Day 729 | All randomized and treated participants, as observed, calculated per modified criteria (UPCR and eGFR only) | Days | MEDIAN |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group426
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period | Abatacept IV | 35.1 | 0.8967 to 1.5726 | Percentage | |
| Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period | Placebo IV | 33.5 | Percentage | ||
| Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period | Abatacept IV | 27 | 0.8967 to 1.5726 | Percentage | |
| Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period | Placebo IV | 29.5 | Percentage | ||
| Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants | Abatacept IV | -5.01 | Standard Error 0.33 | UPCR (mg/mg) | |
| Adjusted Mean Change From Baseline in Urine Protein/Creatinine Ratio (UPCR) at Day 365 of the Double-blind Period in Nephrotic Participants | Placebo IV | -4.84 | Standard Error 0.35 | UPCR (mg/mg) | |
| Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population | Abatacept IV | -2.99 | Standard Error 0.17 | UPCR (mg/mg) | |
| Adjusted Mean Change From Baseline in UPCR at Day 365 of the Double-blind Period in Overall Population | Placebo IV | -2.90 | Standard Error 0.16 | UPCR (mg/mg) | |
| Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period | Abatacept IV | -8.22 | 95% Confidence Interval -9.29 to -7.16 | Scores on a Scale | |
| Adjusted Mean Change From Baseline in Disease Activity as Measured by BILAG 2004 Over Time During Year 1 of the Double-blind Period | Placebo IV | -7.60 | 95% Confidence Interval -8.66 to -6.54 | Scores on a Scale |
1 to 10 of 426Source ClinicalTrials.gov
See all 426 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Year 1 Period | STARTED | Abatacept IV | 203 | |
| Year 1 Period | STARTED | Placebo IV | 203 | |
| Year 1 Period | Treated | Abatacept IV | 202 | |
| Year 1 Period | Treated | Placebo IV | 203 | |
| Year 1 Period | COMPLETED | Abatacept IV | 155 | |
| Year 1 Period | COMPLETED | Placebo IV | 161 | |
| Year 1 Period | NOT COMPLETED | Abatacept IV | 48 | |
| Year 1 Period | NOT COMPLETED | Placebo IV | 42 | |
| Year 2 Period | STARTED | Abatacept IV | 155 | |
| Year 2 Period | STARTED | Placebo IV | 161 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events272
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 | Abatacept IV | 20 | 202 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo IV | 23 | 203 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Abatacept IV | 9 | 202 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo IV | 14 | 203 | |
| other | Diarrhoea | Gastrointestinal disorders | Abatacept IV | 47 | 202 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo IV | 46 | 203 | |
| other | Nausea | Gastrointestinal disorders | Abatacept IV | 13 | 202 | |
| other | Nausea | Gastrointestinal disorders | Placebo IV | 17 | 203 | |
| other | Vomiting | Gastrointestinal disorders | Abatacept IV | 12 | 202 | |
| other | Vomiting | Gastrointestinal disorders | Placebo IV | 7 | 203 |
1 to 10 of 272Source ClinicalTrials.gov
See all 272 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Abatacept IV | 7 | 202 |
| Total, all-cause mortality | Placebo IV | 6 | 203 |
| Total, other adverse events | Abatacept IV | 164 | 202 |
| Total, other adverse events | Placebo IV | 179 | 203 |
| Total, serious adverse events | Abatacept IV | 62 | 202 |
| Total, serious adverse events | Placebo IV | 58 | 203 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41241398 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Abatacept IV vs Placebo IV: Number of Participants With Abatacept Induced Antibody Response Over Time in the Double-blind Period | Trial comparisons |
| Abatacept IV vs Placebo IV: deaths from any cause | Trial comparisons |
| Abatacept IV vs Placebo IV: 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/NCT01714817
GET https://conductscience.org/api/trials/v1/NCT01714817/registered?page=2