Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01714817
First received: October 24, 2012
Last updated: September 23, 2016
Last verified: January 2016
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Purpose
The purpose of this study is to evaluate (Abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)
| Condition | Intervention | Phase |
|---|---|---|
|
Lupus Nephritis |
Biological: BMS-188667 Drug: Mycophenolate mofetil Drug: Prednisone Biological: Placebo matching with BMS-188667 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BMS-188667 (Abatacept) or Placebo on a Background of Mycophenolate Mofetil and Corticosteroids in the Treatment of Subjects With Active Class III or IV Lupus Nephritis |
Resource links provided by NLM:
MedlinePlus related topics:
Steroids
Drug Information available for:
Prednisone
Mycophenolic acid
Mycophenolate sodium
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
Abatacept
U.S. FDA Resources
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Proportion of subjects achieving Complete Response of renal disease following 52 weeks of treatment, where complete response is a composite endpoint based on renal function, proteinuria, urine sediment, and corticosteroid dose [ Time Frame: At Day 365 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of nephrotic subjects in complete renal response of lupus glomerulonephritis [ Time Frame: At Day 365 ] [ Designated as safety issue: No ]
- Mean change in Urine Protein Creatinine ratio (UPCR) from baseline in nephrotic subjects [ Time Frame: At Day 365 ] [ Designated as safety issue: No ]
- Mean change in UPCR from baseline in overall population [ Time Frame: At Day 365 ] [ Designated as safety issue: No ]
- Proportion of nephrotic subjects in complete renal response of lupus glomerulonephritis [ Time Frame: At Day 729 ] [ Designated as safety issue: No ]
- Proportion of subjects with complete renal response of lupus glomerulonephritis in overall population [ Time Frame: At Day 729 ] [ Designated as safety issue: No ]
- Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response [ Time Frame: At Day 365 ] [ Designated as safety issue: No ]
- Proportion of subjects with ranked outcome of complete renal response, partial renal response and no response [ Time Frame: At Day 729 ] [ Designated as safety issue: No ]
- Time to achieving first complete renal response during the double-blind period [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: No ]
- Time to achieving first partial renal response during the double-blind period [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: No ]
- Proportion of subjects meeting each of the components of PR and CR over time during the double-blind period [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: No ]
- Mean change from baseline in disease activity as measured by BILAG 2004 over time during the double-blind period [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: No ]
- Time to and proportion of subjects with sustained change to lower level of response, ie, CR to PR or NR, PR to NR during the double-blind period [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: No ]Sustained response is defined as response present at 2 consecutive visits
- Time to first lupus treatment failure and proportion of subjects in lupus treatment failures overall, and after achievement of CR or PR during the double-blind period [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: No ]
- Time to first overall treatment failure and proportion of subjects in lupus treatment failure overall, and after achievement of CR or PR during the double-blind period [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: No ]
- Safety assessments based on All adverse events (AEs/SAEs) [ Time Frame: Day 15 and 729 ] [ Designated as safety issue: Yes ]AEs = Adverse Events, SAEs = Serious Adverse Events
- Safety assessments based on AEs of interest (infections, malignancies, autoimmune disorders, and infusional reactions) [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: Yes ]
- Safety assessments based on AEs of interest (injection site reactions) [ Time Frame: Day 897 to 1065 ] [ Designated as safety issue: Yes ]
- Safety assessments based on Vital signs [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: Yes ]
- Safety assessments based on Laboratory test abnormalities [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: Yes ]
- Immunogenicity assessment based on Proportion of subjects with abatacept induced antibody response over time in the double blind period [ Time Frame: Day 15 to 729 ] [ Designated as safety issue: Yes ]
- Cmin (µg/mL): Trough level serum concentration of abatacept prior to the administration of the intravenous infusion [ Time Frame: Days 1, 15, 29, 57, 85, 113, 169, 281, 337 ] [ Designated as safety issue: No ]
- Cmax (µg/mL): Maximum observed serum concentration following subjects receiving active abatacept IV [ Time Frame: Day 1 to Day 337 ] [ Designated as safety issue: No ]
- AUC (TAU) (µg•h/mL): Area under the serum concentration time curve over a dosing interval [ Time Frame: Days 337 to 365 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | May 2019 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BMS-188667 + Mycophenolate mofetil + Prednisone
BMS-188667 30 mg/kg injection by intravenous on Days 1,15, 29, and 57, followed by a weight-tiered dose approximating 10mg/kg injection by intravenous every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 weeks
|
Biological: BMS-188667
Other Name: Abatacept
Drug: Mycophenolate mofetil
Other Name: Cellcept
Drug: Prednisone
|
|
Placebo Comparator: Placebo + Mycophenolate mofetil + Prednisone
Placebo matching with BMS-188667 injection by intravenous on Days 1,15, 29, and 57, followed by every 4 weeks, Mycophenolate mofetil 1.5 g tablet by mouth and Prednisone up to 60 mg tablet by mouth Daily for 104 Weeks
|
Drug: Mycophenolate mofetil
Other Name: Cellcept
Drug: Prednisone
Biological: Placebo matching with BMS-188667
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
For additional information please contact the BMS Lupus Nephritis Clinical Trial Matching Service at 855-56-LUPUS. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Note: Subjects > 16 are eligible for enrollment at selected centers
Inclusion Criteria:
- Potential subjects must have active lupus nephritis
- Biopsy within 12 months prior to screening visit indicating active Class 3 or 4 proliferative lupus glomerulonephritis (lupus effecting your kidney)
- Urine protein creatinine ratio (UPCR) ≥ 1 at Screening
- Serum creatinine ≤ 3 mg/dL (ie, ≤ 265 micromol/L)
-
There must also be evidence of active disease within 3 months of Screening, based on at least one of the following:
- Worsening of lupus nephritis OR
- UPCR ≥ 3 at Screening OR
- Active urine sediment OR
- Biopsy within 3 months prior to screening visit indicating active Class 3 or Class 4 active proliferative lupus glomerulonephritis
Inclusion Criteria for the Long-Term Extension Period:
- Signed Written Informed Consent
- Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment
Exclusion Criteria:
- Systemic Lupus Erythematosus (SLE) must be the primary/main autoimmune diagnosis
- Current symptoms of severe, progressive, or uncontrolled non-SLE related renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other concomitant medical conditions that, in the opinion of the Investigator, might place the subject at unacceptable risk for participation in this study
- Significant active Central nervous system (CNS) lupus with the exception of fatigue or mild stable cognitive
- Subjects who are diagnosed as end-stage renal disease or whose kidney damage is too significant and irreversible
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714817
Show 128 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01714817
Show 128 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01714817 History of Changes |
| Other Study ID Numbers: | IM101-291 2012-000714-11 |
| Study First Received: | October 24, 2012 |
| Last Updated: | September 23, 2016 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Korea: Food and Drug Administration Taiwan: Department of Health Taiwan: National Bureau of Controlled Drugs Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: FSI Scientific Center of Expertise of Medical Application Japan: Ministry of Health, Labor and Welfare Japan: Pharmaceuticals and Medical Devices Agency Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Brazil: National Health Surveillance Agency Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Chile: Instituto de Salud Pública de Chile Peru: Instituto Nacional de Salud Mexico: Federal Commission for Sanitary Risks Protection Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Hong Kong: Department of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: National Health and Medical Research Council China: Food and Drug Administration Romania: National Medicines Agency Czech Republic: State Institute for Drug Control Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos |
Additional relevant MeSH terms:
|
Nephritis Lupus Nephritis Kidney Diseases Urologic Diseases Glomerulonephritis Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Abatacept Mycophenolate mofetil Mycophenolic Acid Prednisone |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antibiotics, Antineoplastic Antineoplastic Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on September 30, 2016