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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

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 : Completed
First Posted : September 26, 2016
Results First Posted : January 2, 2020
Last Update Posted : March 19, 2020
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 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
Actual Study Completion Date : July 23, 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
  • Bristol-Myers Squibb (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
  • Bristol-Myers Squibb (BMS)-188667

Other: Placebo



Primary Outcome Measures :
  1. Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) [ Time Frame: Day 169 ]

    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



Secondary Outcome Measures :
  1. Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI) [ Time Frame: Day 169 ]

    The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.

    Total Score Range (0 = Best outcome and 10 = Worst Outcome)

    The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.


  2. Change From Baseline in the Stimulated Whole Salivary Flow [ Time Frame: Day 169 ]
    The mean change from baseline in the stimulated whole salivary flow at Day 169

  3. Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.

    DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.

    (sqrt = Square root, ln = natural log)

    Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity


  4. Change From Baseline of DAS28-CRP: Tender Swollen Joint Count of at Least 3 [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.

    DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.

    (sqrt = Square root, ln = natural log)

    Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity


  5. Change From Baseline of DAS28-CRP: Tender Swollen Joints Count Less Than 3 [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The disease activity score DAS28-CRP is a continuous variable which is a composite of 4 variables: the 28 tender joint count (tender28), the 28 swollen joint count (swollen28), CRP and participant assessment of disease activity measure on a visual analogue scale (VAS) of 100mm.

    DAS28-CRP = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.36 * ln(hsCRP+1) + 0.014 * VAS + 0.96.

    (sqrt = Square root, ln = natural log)

    Positive Scores = Increased Disease Activity Negative Scores = Reduced Disease Activity


  6. Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    Tender Joint: Count 1-28 Swollen Joint: Count 1-28

    Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted


  7. Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    CRP: measured lab value

    Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP


  8. Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    Assesment of Disease Activity: 0-100 scale [100=Most severe]

    Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity


  9. Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3 [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    Tender Joint: Count 1-28 Swollen Joint: Count 1-28

    Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted


  10. Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3 [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    CRP: measured lab value

    Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP


  11. Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3 [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    Assesment of Disease Activity: 0-100 scale [100=Most severe]

    Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity


  12. Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    Tender Joint: Count 1-28 Swollen Joint: Count 1-28

    Negative Scores = Reduced number of joints impacted Positive Scores = Increased number of joints impacted


  13. Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    CRP: measured lab value

    Positive Number = Increased level of CRP Negative Number = Reduced Level of CRP


  14. Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3 [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The mean change from baseline at all measured time points up to Day 169 in the individual components of DAS28-CRP.

    Assesment of Disease Activity: 0-100 scale [100=Most severe]

    Positive Numbers = Increased Disease Activity Negative Numbers = Decreased Diseased activity


  15. Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]
    Proportion of participants who achieve a minimally clinically important change (of at least 3 points) in the ESSDAI at all measured time points up to Day 169.

  16. Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]
    Proportion of participants who achieve a minimally clinically important change (of at least 5 points) in the ESSDAI at all measured time points up to Day 169.

  17. Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]
    Proportion of participants who achieve a minimally clinically important change (of at least 1 point) in the ESSPRI at all measured time points up to Day 169.

  18. Change From Baseline at All Measured Time Points in the ESSDAI [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    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


  19. Change From Baseline at All Measured Time Points in the ESSPRI [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.

    Total Score Range (0 = Best outcome and 10 = Worst Outcome)

    The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.


  20. Change From Baseline in Components of ESSDAI [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169 ]

    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 for activity level) 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, Low = Low Disease Activity, Moderate = Moderate Disease Activity, High = High Disease Activity)


  21. Change From Baseline in ESSPRI Components [ Time Frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169 ]

    The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components.

    Total Score Range (0 = Best outcome and 10 = Worst Outcome)

    The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.


  22. Change From Baseline in Schirmer's Test [ Time Frame: Day 85, Day 169 ]

    The Mean change from baseline in Schirmer's Test at all measured time points up to day 169

    The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.


  23. Change From Baseline in the Ocular Staining Score (OSS) [ Time Frame: Day 85, Day 169 ]

    The Mean change from baseline in OSS at all measured time points up to day 169

    Score of 0 = No Staining Score of 12 = diffuse staining

    The total score will be calculated as the sum of the score for these parameters for each eye.

    Medial Nasal Bulbar Conjunctiva (MNBC) [score scale: 0 - 3], Corneal (CORN) Staining of Punctate Epithelial Erosions (PEE) [score scale: 0 - 3], Lateral Temporal Bulbar Conjunctiva (LTBC) [score scale: 0 - 3], Patches of Confluent Staining (CONF) [score scale: 0 - 1], PEE observed in the pupil region, i.e. central 4mm diameter portion of the cornea (PUPL) [score scale: 0 - 1], one of more filaments seen anywhere on the cornea (FILA) [score scale: 0 - 1]


  24. Change From Baseline in Tear Break-up Time [ Time Frame: Day 85, Day 169 ]

    The Mean change from baseline in Tear Break-up Time at all measured time points up to day 169

    The CRF collects the time in seconds to first appearance of a random dry spot on the corneal surface for 3 repetitions in each eye. The average time will calculated for each eye averaging the 3 measurements for each eye separately. In case only 2 measurements are available, the average of the 2 measurements will be calculated. In case there is only 1 measurement, that measurement will be used for the analysis.


  25. Change From Baseline in Unstimulated Salivary Flow [ Time Frame: Day 85, Day 169 ]
    The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.

  26. Change From Baseline in Stimulated Salivary Flow [ Time Frame: Day 85, Day 169 ]
    The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.

  27. Change From Baseline in Numeric Rating Scale for Mouth Dryness [ Time Frame: Day 1, 29, 57, 85, 113, 141, 169 ]

    The mean change from baseline in participant symptoms using the Numeric Rating Scale (NRS) for mouth dryness at all measured time points up to Day 169.

    The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness


  28. Change From Baseline in Numeric Rating Scale for Eye Dryness [ Time Frame: Day 1, 29, 57, 85, 113, 141, 169 ]

    The mean change from baseline in patient symptoms using the Numeric Rating Scale (NRS) for eye dryness at all measured time points up to Day 169.

    The oral and ocular dryness are each assessed by the patients with numeric rating scales from 0 to 10 with 0 representing no dryness and 10 representing maximal dryness


  29. Change From Baseline in Participant Assessment of Disease Activity [ Time Frame: Day 29, 57, 85, 113, 141, 169 ]

    The participant global assessment of disease activity are assessed with visual analog scales. The participant marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.

    In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:

    Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) * 100mm

    A negative score = participant assessment of disease activity has improved

    A positive score = participant assessment of disease activity has worsened


  30. Change From Baseline in Physician Global Assessment of Disease Activity [ Time Frame: Day 29, 57, 85, 113, 141, 169 ]

    The physician global assessment of disease activity are assessed with visual analog scales. The physician marks a vertical line through a horizontal line, where the beginning of the horizontal line represents the best situation, and the end of the horizontal line represents the very worst situation. The CRF collects the distance in millimeters from the start of the scale that is marked as well as the length of the scale in millimeters.

    In cases that the length of the scale is in less or more than 100 millimeters, then the participants measurement will be rescaled to the equivalent of 100 millimeters using the formula below:

    Rescale Measurement in mm = (measurement as reported on CRF in mm/length of the line on CRF in mm) * 100mm

    A negative score = physician assessment of disease activity has improved

    A positive score = physician assessment of disease activity has worsened


  31. Change From Baseline in Patient Fatigue [ Time Frame: Day 29, 57, 85, 113, 141, 169 ]

    The mean change from baseline in patient fatigue using Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue assessment of disease activity at all measured time points up to Day 169.

    PROMIS Fatigue instruments 10 Questions ranging from a score 0 to 40. Sum of the values gives you the raw sum. The raw is inputted into this formula to give you the raw score:

    Raw Score = (Raw sum*number of items on the short form)/(Number of items that were actually answered)

    Raw score is translated to a T-Score using a table. T-Score is used as the final score.

    The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. The standardized T-score is reported as the final score for each participant.

    A negative T Score = Better Prognosis A positive T Score = Worse prognosis


  32. Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI) [ Time Frame: Day 85, Day 169 ]

    For the FSFI, is a 19 item instrument used for assessing key dimensions of female sexual function over the past 4 weeks with 6 domains being analyzed. The specific domains (desire, arousal, lubrication, orgasm, satisfaction, and pain) analyzed in the FSFI are scored on a scale ranging from 0 to 5, with higher scores indicating better performance. Domain scores are calculated by summing the scores of the individual questions that make up the domain and multiplying the sum by the factor in the table below. The full scale score is the sum of the six domain scores.

    Full Scale Score range: 2.0(minimum score) - 36.0 (maximum score)

    Negative Score = Reduced functioning Positive Score = Improved functioning


  33. Change From Baseline in 36-item Short Form Health Survey (SF-36) [ Time Frame: Day 85, Day 169 ]

    The SF-36 determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health.

    Scores on each item are summed and averaged (range: 0=worst to 100=best). Increases from baseline indicate improvement


  34. Geometric Mean of Trough Concentration (Cmin) of Abatacept [ Time Frame: Day 29, 85, 113, 141, 169 ]
    Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.

  35. Percentage of Participants With a Positive Antibody Response [ Time Frame: Day 85 db, day 169 db, post treatment day 85 ]
    Percentage of participants with at least one positive immunogenicity response up to Day 169 and during 3 months follow up (for participants who discontinue during the 6-months double-blind).

  36. Summary of Adverse Events: Double Blind Period [ Time Frame: Day 1 up to first dose of Open Label Treatment Period (OLTP) abatacept or up to 56 post last dose in double -blind for those not in OL. ]
    Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation

  37. Laboratory Marked Abnormalities: Double Blind Period [ Time Frame: Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL. ]
    Laboratory values meeting the marked abnormality criteria



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.


Layout table for eligibility information
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:

  • 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)

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


Locations
Show Show 71 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Statistical Analysis Plan  [PDF] June 17, 2019
Study Protocol  [PDF] August 25, 2016


Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02915159    
Other Study ID Numbers: IM101-603
2016-001948-19 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: March 19, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
Layout table for 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