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Trial record 1 of 1 for:    IM101-603
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A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome

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ClinicalTrials.gov Identifier: NCT02915159
Recruitment Status : Active, not recruiting
First Posted : September 26, 2016
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Sjogrens Disease Biological: Abatacept Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 253 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome
Actual Study Start Date : December 6, 2016
Actual Primary Completion Date : August 7, 2018
Estimated Study Completion Date : January 14, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
Experimental: Abatacept
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 Names:
  • Orencia
  • BMS-188667

Placebo Comparator: Placebo
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 Names:
  • Orencia
  • BMS-188667

Other: Placebo



Primary Outcome Measures :
  1. Change from baseline in EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) [ Time Frame: Day 1 to Day 169 ]

Secondary Outcome Measures :
  1. Change from baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) [ Time Frame: Day 1 to Day 169 ]
  2. Mean change from baseline in the stimulated whole salivary flow among subjects with stimulated whole salivary flow of at least 0.1 mL/min at both screening and baseline [ Time Frame: Day 1 to Day 169 ]
  3. Proportion of subjects with a least one positive immunogenicity response as measured by anti-abatacept antibody testing [ Time Frame: Up to 1 year ]
  4. Proportion of subjects with adverse events (AEs) [ Time Frame: Day 1 to 168 days after the last dose of study drug ]
  5. Proportion of subjects with serious adverse events (SAEs) [ Time Frame: Day 1 to 168 days after the last dose of study drug ]
  6. Proportion of subjects with AEs leading to discontinuation [ Time Frame: Day 1 to 168 days after the last dose of study drug ]
  7. Proportion of Deaths [ Time Frame: Day 1 to 56 days after the last dose of study drug ]
  8. Proportion of subjects with laboratory abnormalities [ Time Frame: Day 1 to 56 days after the last dose of study drug ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915159


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Locations
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United States, California
St. Jude Hospital Yorba Linda
Fullerton, California, United States, 92835
Riverside Medical Clinic
Riverside, California, United States, 92506
United States, Colorado
Colorado Arthritis Associates
Lakewood, Colorado, United States, 80228
United States, Georgia
North Georgia Rheumatology Group
Lawrenceville, Georgia, United States, 30046
United States, Idaho
Intermountain Research Center Inc.
Boise, Idaho, United States, 83702
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01605
United States, Minnesota
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States, 55121
United States, New York
Northwell Health
Great Neck, New York, United States, 11021
United States, North Carolina
Local Institution
Charlotte, North Carolina, United States, 28203
Joint and Muscle Medical Care and Research Institute (JMMCRI)
Charlotte, North Carolina, United States, 28204
Duke Clinical Research Unit, Duke Univ Med Ctr, Duke South
Durham, North Carolina, United States, 27710
United States, Oklahoma
Health Research Of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
East Penn Rheumatology
Bethlehem, Pennsylvania, United States, 18015
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635-8406
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Scott Zashin Inc.
Dallas, Texas, United States, 75231
Argentina
Organizacion Medica De Investigacion S.A. (Omi)
Capital Federal, Buenos Aires, Argentina, 1015
Local Institution
Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
Instituto de Asistencia Reumatologica Integral
San Fernando, Buenos Aires, Argentina, 1646
Local Institution
Buenos Aires, Argentina, 1428
Consultorios Medicos Dr. Catalan Pellet
Caba, Argentina, 1111
Instituto Reumatologico Strusberg
Cordoba, Argentina, 5000
Australia, Queensland
Local Institution
Maroochydore, Queensland, Australia, 4558
Australia, South Australia
Local Institution
Woodville, South Australia, Australia, 5011
Australia, Victoria
Local Institution
Camberwell, Victoria, Australia, 3124
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Brazil
Local Institution
Savaldor, Bahia, Brazil, 40150-150
Local Institution
Vitoria, ES, Brazil, 29055-450
Local Institution
Porto Alegre, RIO Grande DO SUL, Brazil, 90480-000
Local Institution
Sao Paulo, Brazil, 04032-060
Czechia
Revmatologie s.r.o.
Brno, Czechia, 638 00
France
Local Institution
Bordeaux, France, 33075
Local Institution
Le Kremlin Bicetre Cedex, France, 94275
Local Institution
Marseille, France, 13003
Local Institution
Marseille, France, 13008
Local Institution
Montpellier Cedex 5, France, 34295
Local Institution
Paris Cedex 10, France, 75475
Local Institution
Strasbourg, France, 67098
Germany
Medizinische Universitaetsklinik Freiburg
Freiburg, Germany, 79106
Med Hochschule Hannover
Hannover, Germany, 30625
Krankenhaus St. Josef
Wuppertal, Germany, 42105
Italy
Local Institution
Milano, Italy, 20122
Ospedale Santa Maria Della Misericordia
Udine, Italy, 33100
Japan
Local Institution
Nagoya-shi, Aichi, Japan, 4578511
Local Institution
Kitakyushu-shi, Fukuoka, Japan, 8078555
Local Institution
Sapporo-shi, Hokkaido, Japan, 0608648
Local Institution
Nishinomiya-shi, Hyogo, Japan, 6638501
Local Institution
Tsukuba-shi, Ibaraki, Japan, 3050005
Local Institution
Kamigyo-ku, Kyoto, Japan, 602-8566
Local Institution
Sendai-shi, Miyagi, Japan, 9808574
Local Institution
Nagasaki-shi, Nagasaki, Japan, 8528501
Local Institution
Kurashiki-shi, Okayama, Japan, 7108522
Local Institution
Hamamatsu-shi, Shizuoka, Japan, 4313192
Local Institution
Chuo-ku, Tokyo, Japan, 1048560
Local Institution
Itabashi-ku, Tokyo, Japan, 1738610
Local Institution
Meguro-ku, Tokyo, Japan, 1538515
Local Institution
Shinjuku-Ku, Tokyo, Japan, 1608582
Korea, Republic of
Local Institution
Daegu, Korea, Republic of, 42472
Local Institution
Gwangju, Korea, Republic of, 61469
Local Institution
Seoul, Korea, Republic of, 06591
Mexico
Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia
Leon, Guanajuato, Mexico, 37000
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo LEON, Mexico, 64460
Local Institution
Distrito Federal, Mexico, 14080
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
San Luis Potosi, Mexico, 78213
Puerto Rico
Local Institution
San Juan, Puerto Rico, 00909
Local Institution
San Juan, Puerto Rico, 00918
Sweden
Local Institution
Solna, Sweden, 171 64
Local Institution
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02915159     History of Changes
Other Study ID Numbers: IM101-603
2016-001948-19 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Sjogren's Syndrome
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents