Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

NCT01714817 | Terminated Phase 3 Results DMC

• 2 other identifiers: IM101-2912012-000714-11
• Study Type: interventional
• Target: 695
• Locations: 23 countries
• Sites: 149

Brief Summary

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)

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants in Complete Renal Response (CR) of Lupus Glomerulonephritis at Day 365 of the Double-blind Period

  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.

  Day 365

Secondary Outcomes (44)

• Percentage of Nephrotic Participants in Complete Renal Response of Lupus Glomerulonephritis at Day 365 of the Double-blind Period

  Day 365

• 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 Overall Population

  Day 1 and Day 365

• 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

• 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

Study Arms (2)

BMS-188667 + Mycophenolate mofetil + Prednisone

EXPERIMENTAL

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; Drug: Mycophenolate mofetil; Drug: Prednisone

Placebo + Mycophenolate mofetil + Prednisone

PLACEBO COMPARATOR

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; Drug: Prednisone; Biological: Placebo matching with BMS-188667

Interventions

BMS-188667 BIOLOGICAL

Also known as: Abatacept

BMS-188667 + Mycophenolate mofetil + Prednisone

Mycophenolate mofetil DRUG

Also known as: Cellcept

BMS-188667 + Mycophenolate mofetil + Prednisone; Placebo + Mycophenolate mofetil + Prednisone

Prednisone DRUG

BMS-188667 + Mycophenolate mofetil + Prednisone; Placebo + Mycophenolate mofetil + Prednisone

Placebo matching with BMS-188667 BIOLOGICAL

Placebo + Mycophenolate mofetil + Prednisone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Signed Written Informed Consent
• Subjects who achieve a complete or partial renal response after completing 2 years of double-blind treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (149)

University Of Alabama At Birmingham (Uab)

Birmingham, Alabama, 35294, United States

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Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.

Long Beach, California, 90806, United States

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East Bay Rheumatology Medical Group, Inc.

San Leandro, California, 94578, United States

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University Of Connecticut Health Center

Farmington, Connecticut, 06030, United States

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University Of Miami Miller School Of Medicine

Miami, Florida, 33136, United States

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Integral Rheumatology & Immunology Specialists

Plantation, Florida, 33324, United States

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Emory University.

Atlanta, Georgia, 30303, United States

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Rush University Medical Center

Chicago, Illinois, 60612, United States

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Ochsner Clinic Foundation

Baton Rouge, Louisiana, 70809, United States

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Tulane University School Of Medicine

New Orleans, Louisiana, 70112, United States

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Brigham & Women'S Hospital

Boston, Massachusetts, 02115, United States

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Boston University Medical Center

Boston, Massachusetts, 02118, United States

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Local Institution

Camden, New Jersey, 08103, United States

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Suny Downstate Medical Center

Brooklyn, New York, 11203-2056, United States

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Northshore Lij Health System

Great Neck, New York, 11021, United States

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The Feinstein Institute For Medical Research

Manhasset, New York, 11030, United States

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Hospital For Special Surgery

New York, New York, 10021-4892, United States

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Local Institution

New York, New York, 10032, United States

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University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27599, United States

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Shanahan Rheum & Immunotherapy, PLLC

Raleigh, North Carolina, 27617, United States

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MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

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Paramount Medical Research & Consulting, Llc

Middleburg Heights, Ohio, 44130, United States

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Rheumatology Consultants Pllc

Knoxville, Tennessee, 37909-1907, United States

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UT Southwestern Medical Center

Dallas, Texas, 75390, United States

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University Of Utah Hospital

Salt Lake City, Utah, 84112, United States

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Local Institution

Charlottesville, Virginia, 22908, United States

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Organizacion Medica De Investigacion S.A. (Omi)

Capital Federal, Buenos Aires, 1015, Argentina

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Capital Federal, Buenos Aires, 1431, Argentina

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Buenos Aires, 1181, Argentina

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Hospital Privado-Centro Medico De Cordoba S.A.

Córdoba, 5016, Argentina

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Adelaide, South Australia, 5000, Australia

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Parkville, Victoria, 3050, Australia

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Perth, Western Australia, 6009, Australia

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Savaldor, Estado de Bahia, 40150-150, Brazil

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Goiânia, Goiás, 74110-120, Brazil

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Belo Horizonte, Minas Gerais, 30150-320, Brazil

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Juiz de Fora, Minas Gerais, 36010-570, Brazil

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Uberlândia, Minas Gerais, 38400-902, Brazil

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Porto Alegre, Rio Grande do Sul, 91610000, Brazil

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São Paulo, 01323-900, Brazil

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Mississauga, Ontario, L5M 2V8, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Viña del Mar, Región de Valparaíso, 2570017, Chile

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Independencia, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, 8330024, Chile

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Santiago, Santiago Metropolitan, 8360156, Chile

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Beijing, Beijing Municipality, 100034, China

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Beijing, Beijing Municipality, 100044, China

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Guangzhou, Guangdong, 510080, China

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Haikou, Hainan, 570311, China

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Wuhan, Hebei, 430030, China

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Harbin, Heilongjiang, 150001, China

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Zhengzhou, Henan, 450004, China

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Wuxi, Jiangsu, 214023, China

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Nanchang, Jiangxi, China

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Xi'an, Shan1xi, 710054, China

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Shanghai, Shanghai Municipality, 200032, China

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Chengdu, Sichuan, 610041, China

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Hangzhou, Zhejiang, 310003, China

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Beijing, 100029, China

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Chongqing, 400010, China

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Guangzhou, China

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Nanchang, 330006, China

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Nanning, 530000, China

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Shanghai, 200001, China

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Shanghai, 200025, China

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Shanghai, China

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Xi'an, China

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Riesgo De Fractura S.A. Cayre Ips

Bogota, Cundinamarca, Colombia

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Servimed E.U

Bucaramanga, Santander Department, Colombia

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Clinica De La Costa

Barranquilla, XXXXXX, Colombia

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Circaribe S.A.S

Barranquilla, Colombia

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Hospital Universitario San Ignacio

Bogotá, Colombia

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Hospital Pablo Tobon Uribe

Medellín, MEDELLIN, Colombia

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Prague, 128 50, Czechia

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Hong Kong, Hong Kong

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Secunderabad, Andhra Pradesh, 500003, India

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Ahmedabad, Gujarat, 380052, India

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Gūrgaon, 122001, India

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Hyderabad, 500004, India

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Lucknow, 226018, India

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New Delhi, 110029, India

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Haifa, 31048, Israel

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Haifa, 31096, Israel

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Ramat Gan, Israel

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Tel Aviv, 64239, Israel

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Brescia, 25123, Italy

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Milan, 20122, Italy

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Padua, 35128, Italy

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Reggio Emilia, 42100, Italy

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Torino, 10128, Italy

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Nagakute-shi, Aichi-ken, 4801195, Japan

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Nagoya, Aichi-ken, 4668560, Japan

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Chiba, Chiba, 2608677, Japan

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Fukuoka, Fukuoka, 8108563, Japan

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Kitakyushu-shi, Fukuoka, 8078555, Japan

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Maebashi, Gunma, 3718511, Japan

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Sapporo, Hokkaido, 0608604, Japan

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Sapporo, Hokkaido, Japan

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Kanazawa, Ishikawa-ken, 9208641, Japan

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Yokohama, Kanagawa, 2360004, Japan

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Sendai, Miyagi, 9808574, Japan

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Nagasaki, Nagasaki, 8528501, Japan

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Niigata, Niigata, 9518520, Japan

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Okayama, Okayama-ken, 7008558, Japan

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Iruma-gun, Saitama, 3500495, Japan

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Shimotsuke-shi, Tochigi, 3290498, Japan

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Bunkyo-ku, Tokyo, 1138431, Japan

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Bunkyo-ku, Tokyo, 1138519, Japan

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Chuo-ku, Tokyo, 1048560, Japan

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Fuchū, Tokyo, 1838524, Japan

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Ōta-ku, Tokyo, 1438541, Japan

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Shinjuku-Ku, Tokyo, 1608582, Japan

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Kita-gun, 7610793, Japan

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Osaka, 5308480, Japan

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Mexico City, Distrito Fededral, 11850, Mexico

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Centro De Est D Inv. Basica Y Clinica

Guadalajara, Jalisco, 44690, Mexico

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Local Institution

Guadalajara, Jalisco, Jalisco, 44160, Mexico

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Hospital De Jesus

Mexico City, Mexico City, 06090, Mexico

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Hospital General De Mexico O.D.

Mexico City, Mexico City, 06726, Mexico

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Centro Medico De Las Americas

Mérida, Yucatán, 97000, Mexico

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Instituto Nacional De Ciencias Medicas Y Nutricion S.Z.

Distrito Federal, 14080, Mexico

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Centro Potosino de Inv Clinica

San Luis Potosí City, 78200, Mexico

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Hosp Central I.Morones Prieto

San Luis Potosí City, 78240, Mexico

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Hospital Nacional Guillermo Almenara Irigoyen

Lima, 13, Peru

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Hospital Nacional Cayetano Heredia

Lima, LIMA 31, Peru

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Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

Lima, LIMA 33, Peru

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San Juan, 00927, Puerto Rico

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Bucharest, 010976, Romania

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Bucharest, 011192, Romania

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Bucharest, 020125, Romania

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Cluj-Napoca, 400006, Romania

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Iași, 700503, Romania

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Moscow, 115522, Russia

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Saint Petersburg, 197341, Russia

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Ufa, 450005, Russia

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Daegu, 41944, South Korea

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Seoul, 06591, South Korea

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Seoul, 07345, South Korea

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Madrid, 28007, Spain

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Madrid, 28041, Spain

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Kaohsiung City, 80756, Taiwan

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Kaohsiung City, 833, Taiwan

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Taichung, 40447, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 10051, Taiwan

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Taoyuan District, 333, Taiwan

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Antalya, 07070, Turkey (Türkiye)

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Edirne, 22030, Turkey (Türkiye)

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Related Publications (1)

• O'Connor SK, Devarajan P, Liu J, Maldonado MA, Sproles A, Rose J, Thornton S, Chen C, Huang B, Brunner HI. The Renal Activity Index for Lupus: Validation for Prediction of Kidney Inflammation in Adult Patients With Lupus Nephritis. J Rheumatol. 2026 Jan 15:jrheum.2025-0504. doi: 10.3899/jrheum.2025-0504. Online ahead of print.

  PMID: 41241398 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Abatacept; Mycophenolic Acid; Prednisone

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

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.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email:

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: January 22, 2013
• Primary Completion: November 21, 2016
• Study Completion: May 30, 2018
• Last Updated: February 26, 2021
• Results First Posted: December 21, 2017

Record last verified: 2021-02

Locations

RU (3); IT (5); KR (3); ES (2); TW (6); RO (5); CL (4); TU (2); US (26); CA (2); PE (3); AU (3); PR (1); IL (4); CZ (1); JP (24); ME (9); BR (7); CO (6); CN (22); AR (4); IN (6); HK (1)