ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02915159
Recruitment Status : Active, not recruiting
First Posted : September 26, 2016
Last Update Posted : July 3, 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

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
Estimated Primary Completion Date : August 6, 2018
Estimated Study Completion Date : July 31, 2019

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

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, Learn About Clinical Studies.


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


  Show 72 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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: July 3, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
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