A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome

NCT02915159 | Completed Phase 3 Results DMC

• 2 other identifiers: IM101-6032016-001948-19
• Study Type: interventional
• Target: 250
• Locations: 13 countries
• Sites: 71

Brief Summary

The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.

Conditions

Sjogrens Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)

  The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) Scoring Algorithm. Domain: (Score) Constitutional: (No=0, Low=3, Moderate=6) Lymphadenopathy: (No=0, Low=4, Moderate=8, High=12) Glandular: (No=0, Low=2, Moderate=4) Articular: (No=0, Low=2, Moderate=4, High=6) Cutaneous: (No=0, Low=3, Moderate=6, High=9) Pulmonary: (No=0, Low=5, Moderate=10, High=15) Renal: (No=0, Low=5, Moderate=10, High=15) Muscular: (No=0, Low=6, Moderate=12, High=18) Peripheral Nervous System (PNS): (No=0, Low=5, Moderate=10, High=15) Central Nervous System (CNS): (No=0, Moderate=10, High=15) Haematological: (No=0, Low=2, Moderate=4, High=6) Biological: (No=0, Low=1, Moderate=2) (No = No Disease Activity (DA), Low = Low DA, Moderate = Moderate DA, High = High DA) Overall score, which can range from 0 to 123, a higher score indicates more disease activity

  Day 169

Secondary Outcomes (40)

• Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)

  Day 169

• Change From Baseline in the Stimulated Whole Salivary Flow

  Day 169

• Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population

  Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

• Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3

  Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

• Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3

  Day 29, Day 57, Day 85, Day 113, Day 141, Day 169

Study Arms (2)

Abatacept

EXPERIMENTAL

Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months followed by Open-Label Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months

Biological: Abatacept

Placebo

PLACEBO COMPARATOR

Placebo for Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months followed by Open-Label Abatacept for subcutaneous injection 125mg/mL in 1 mL pre-filled syringe for 6 months

Biological: Abatacept; Other: Placebo

Interventions

Abatacept BIOLOGICAL

Also known as: Orencia, Bristol-Myers Squibb (BMS)-188667

Abatacept; Placebo

Placebo OTHER

Placebo

Eligibility Criteria

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

You may qualify if:

• EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score of at least 5
• Positive anti-SS-A/Ro antibody at screening
• meet the 2016 American College of Rheumatology (ACR) / European League Against Rheumatism Classification Criteria for Sjögren's Syndrome (EULAR SS)

You may not qualify if:

• Secondary Sjögrens syndrome
• Active life-threatening or organ-threatening complications of Sjögren's-syndrome
• Other medical condition associated with sicca syndrome

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (71)

St. Jude Hospital Yorba Linda

Fullerton, California, 92835, United States

Location

Riverside Medical Clinic

Riverside, California, 92506, United States

Location

Colorado Arthritis Associates

Lakewood, Colorado, 80228, United States

Location

North Georgia Rheumatology Group

Lawrenceville, Georgia, 30046, United States

Location

Intermountain Research Center Inc.

Boise, Idaho, 83702, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

St. Paul Rheumatology, P.A.

Eagan, Minnesota, 55121, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Local Institution

Charlotte, North Carolina, 28203, United States

Location

Joint and Muscle Medical Care and Research Institute (JMMCRI)

Charlotte, North Carolina, 28204, United States

Location

Duke Clinical Research Unit, Duke Univ Med Ctr, Duke South

Durham, North Carolina, 27710, United States

Location

Health Research Of Oklahoma

Oklahoma City, Oklahoma, 73103, United States

Location

East Penn Rheumatology

Bethlehem, Pennsylvania, 18015, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635-8406, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, 38305, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Scott Zashin Inc.

Dallas, Texas, 75231, United States

Location

Organizacion Medica De Investigacion S.A. (Omi)

Capital Federal, Buenos Aires, 1015, Argentina

Location

Local Institution

Ciudad Autonoma Beunos Aires, Buenos Aires, 1431, Argentina

Location

Instituto de Asistencia Reumatologica Integral

San Fernando, Buenos Aires, 1646, Argentina

Location

Local Institution

Buenos Aires, 1428, Argentina

Location

Consultorios Medicos Dr. Catalan Pellet

CABA, 1111, Argentina

Location

Instituto Reumatologico Strusberg

Córdoba, 5000, Argentina

Location

Local Institution

Maroochydore, Queensland, 4558, Australia

Location

Local Institution

Woodville, South Australia, 5011, Australia

Location

Local Institution

Camberwell, Victoria, 3124, Australia

Location

Local Institution

Nedlands, Western Australia, 6009, Australia

Location

Local Institution

Vitória, Espírito Santo, 29055-450, Brazil

Location

Local Institution

Savaldor, Estado de Bahia, 40150-150, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 90480-000, Brazil

Location

Local Institution

São Paulo, 04032-060, Brazil

Location

Revmatologie s.r.o.

Brno, 638 00, Czechia

Location

Local Institution

Bordeaux, 33075, France

Location

Local Institution

Le Kremlin-Bicêtre, 94275, France

Location

Hopital Europeen

Marseille, 13003, France

Location

Local Institution

Marseille, 13008, France

Location

Hopital Lapeyronie

Montpellier, 34295, France

Location

Local Institution

Paris, 75475, France

Location

Local Institution

Strasbourg, 67098, France

Location

Medizinische Universitaetsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Med Hochschule Hannover

Hanover, 30625, Germany

Location

Krankenhaus St. Josef

Wuppertal, 42105, Germany

Location

Local Institution

Milan, 20122, Italy

Location

Ospedale Santa Maria Della Misericordia

Udine, 33100, Italy

Location

Local Institution

Nagoya, Aichi-ken, 4578511, Japan

Location

Local Institution

Kitakyushu-shi, Fukuoka, 8078555, Japan

Location

Local Institution

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution

Nishinomiya-shi, Hyōgo, 6638501, Japan

Location

Local Institution

Tsukuba, Ibaraki, 3050005, Japan

Location

Local Institution

Kamigyō-ku, Kyoto, 602-8566, Japan

Location

Local Institution

Sendai, Miyagi, 9808574, Japan

Location

Local Institution

Nagasaki, Nagasaki, 8528501, Japan

Location

Local Institution

Kurashiki-shi, Okayama-ken, 7108522, Japan

Location

Local Institution

Hamamatsu, Shizuoka, 4313192, Japan

Location

Local Institution

Chuo-ku, Tokyo, 1048560, Japan

Location

Local Institution

Itabashi-ku, Tokyo, 1738610, Japan

Location

Local Institution

Meguro-ku, Tokyo, 1538515, Japan

Location

Local Institution

Shinjuku-Ku, Tokyo, 1608582, Japan

Location

Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia

León, Guanajuato, 37000, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution

Distrito Federal, 14080, Mexico

Location

Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

San Luis Potosí City, 78213, Mexico

Location

Local Institution

San Juan, 00909, Puerto Rico

Location

Local Institution

San Juan, 00918, Puerto Rico

Location

Local Institution

Daegu, 42472, South Korea

Location

Local Institution

Gwangju, 61469, South Korea

Location

Local Institution

Seoul, 06591, South Korea

Location

Local Institution

Solna, 171 64, Sweden

Location

Local Institution

Uppsala, 751 85, Sweden

Location

Related Links

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

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

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: LTE60
• 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: September 23, 2016
• First Posted: September 26, 2016
• Study Start: December 6, 2016
• Primary Completion: August 7, 2018
• Study Completion: July 23, 2019
• Last Updated: August 10, 2020
• Results First Posted: January 2, 2020

Record last verified: 2020-07

Locations

SE (2); US (19); ME (4); FR (7); AR (6); JP (14); DE (3); BR (4); CZ (1); IT (2); PR (2); KR (3); AU (4)