Sjogrens DiseasePhase 3NCT02915159
A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome
A Phase 3 study testing Abatacept in people with Sjogrens Disease, run by Bristol-Myers Squibb at 71 sites in 13 countries.
Trial summary
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogrens Disease
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 71 sitesin 13 countries
- Study dates
- 6 Dec 2016to 23 Jul 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
71 sites in 13 countries.
71 sites in 13 countries
United States19 sites
Johns Hopkins University
Baltimore, Maryland, 21224
East Penn Rheumatology
Bethlehem, Pennsylvania, 18015
Intermountain Research Center Inc.
Boise, Idaho, 83702
Local Institution
Charlotte, North Carolina, 28203
Joint and Muscle Medical Care and Research Institute (JMMCRI)
Charlotte, North Carolina, 28204
Metroplex Clinical Research Center
Dallas, Texas, 75231
Scott Zashin Inc.
Dallas, Texas, 75231
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635-8406
Duke Clinical Research Unit, Duke Univ Med Ctr, Duke South
Durham, North Carolina, 27710
St. Paul Rheumatology, P.A.
Eagan, Minnesota, 55121
St. Jude Hospital Yorba Linda
Fullerton, California, 92835
Northwell Health
Great Neck, New York, 11021
West Tennessee Research Institute
Jackson, Tennessee, 38305
Colorado Arthritis Associates
Lakewood, Colorado, 80228
North Georgia Rheumatology Group
Lawrenceville, Georgia, 30046
Health Research Of Oklahoma
Oklahoma City, Oklahoma, 73103
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Riverside Medical Clinic
Riverside, California, 92506
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605
Japan14 sites
Local Institution
Chuo-ku, Tokyo, 1048560
Local Institution
Hamamatsu, Shizuoka, 4313192
Local Institution
Kamigyō-ku, Kyoto, 602-8566
Local Institution
Kitakyushu-shi, Fukuoka, 8078555
Local Institution
Kurashiki-shi, Okayama-ken, 7108522
Local Institution
Meguro-ku, Tokyo, 1538515
Local Institution
Nagasaki, Nagasaki, 8528501
Local Institution
Nagoya, Aichi-ken, 4578511
Local Institution
Nishinomiya-shi, Hyōgo, 6638501
Local Institution
Sapporo, Hokkaido, 0608648
Local Institution
Sendai, Miyagi, 9808574
Local Institution
Shinjuku-Ku, Tokyo, 1608582
Local Institution
tabashi City, Tokyo, 1738610
Local Institution
Tsukuba, Ibaraki, 3050005
France7 sites
Local Institution
Bordeaux, 33075
Local Institution
Le Kremlin-Bicêtre, 94275
Hopital Europeen
Marseille, 13003
Local Institution
Marseille, 13008
Hopital Lapeyronie
Montpellier, 34295
Local Institution
Paris, 75475
Local Institution
Strasbourg, 67098
Argentina6 sites
Local Institution
Buenos Aires, 1428
Consultorios Medicos Dr. Catalan Pellet
CABA, 1111
Organizacion Medica De Investigacion S.A. (Omi)
Capital Federal, Buenos Aires, 1015
Local Institution
Ciudad Autonoma Beunos Aires, Buenos Aires, 1431
Instituto Reumatologico Strusberg
Córdoba, 5000
Instituto de Asistencia Reumatologica Integral
San Fernando, Buenos Aires, 1646
Australia4 sites
Local Institution
Camberwell, Victoria, 3124
Local Institution
Maroochydore, Queensland, 4558
Local Institution
Nedlands, Western Australia, 6009
Local Institution
Woodville, South Australia, 5011
Brazil4 sites
Local Institution
Porto Alegre, Rio Grande do Sul, 90480-000
Local Institution
São Paulo, 04032-060
Local Institution
Savaldor, Estado de Bahia, 40150-150
Local Institution
Vitória, Espírito Santo, 29055-450
Mexico4 sites
Local Institution
Distrito Federal, 14080
Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia
León, Guanajuato, 37000
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 64460
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
San Luis Potosí City, 78213
Germany3 sites
Medizinische Universitaetsklinik Freiburg
Freiburg im Breisgau, 79106
Med Hochschule Hannover
Hanover, 30625
Krankenhaus St. Josef
Wuppertal, 42105
South Korea3 sites
Local Institution
Daegu, 42472
Local Institution
Gwangju, 61469
Local Institution
Seoul, 06591
Italy2 sites
Local Institution
Milan, 20122
Ospedale Santa Maria Della Misericordia
Udine, 33100
Puerto Rico2 sites
Local Institution
San Juan, 00909
Local Institution
San Juan, 00918
About this study
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
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.
- Conditions
- Sjogrens Disease
- Being tested
- Abatacept, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptBiological
Also called Orencia, Bristol-Myers Squibb (BMS)-188667
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Biological: Abatacept; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 169
Secondary outcomes (40)
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)
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.
Measured: Day 169
Change From Baseline in the Stimulated Whole Salivary Flow
The mean change from baseline in the stimulated whole salivary flow at Day 169
Measured: Day 169
Change From Baseline of DAS28-C-reactive Peptide (CRP): In The Full Population
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
Measured: 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
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
Measured: 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
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the Joint Component of DAS28-CRP: In the Full Population
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the CRP Component of DAS28-CRP: In the Full Population
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: In the Full Population
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joints of at Least 3
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joints of at Least 3
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joints of at Least 3
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the Joint Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the CRP Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in the Assessment of Disease Activity Component of DAS28-CRP: Tender Swollen Joint Count Less Than 3
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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 3 Points
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.
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Participants Who Achieve Minimally Clinically Important Change in ESSDAI in at Least 5 Points
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.
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Participants Who Achieve Minimally Clinically Important Change in ESSPRI in at Least 1 Point
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.
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline at All Measured Time Points in the 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
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline at All Measured Time Points in the ESSPRI
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.
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in Components of 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 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)
Measured: Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
Change From Baseline in ESSPRI Components
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.
Measured: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in Schirmer's Test
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.
Measured: Day 85, Day 169
Change From Baseline in the Ocular Staining Score (OSS)
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]
Measured: Day 85, Day 169
Change From Baseline in Tear Break-up Time
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.
Measured: Day 85, Day 169
Change From Baseline in Unstimulated Salivary Flow
The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Day 169.
Measured: Day 85, Day 169
Change From Baseline in Stimulated Salivary Flow
The mean change from baseline in Stimulated whole salivary flow at all measured time points up to Day 169.
Measured: Day 85, Day 169
Change From Baseline in Numeric Rating Scale for Mouth Dryness
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
Measured: Day 1, 29, 57, 85, 113, 141, 169
Change From Baseline in Numeric Rating Scale for Eye Dryness
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
Measured: Day 1, 29, 57, 85, 113, 141, 169
Change From Baseline in Participant Assessment of Disease Activity
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
Measured: Day 29, 57, 85, 113, 141, 169
Change From Baseline in Physician Global Assessment of Disease Activity
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
Measured: Day 29, 57, 85, 113, 141, 169
Change From Baseline in Patient Fatigue
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
Measured: Day 29, 57, 85, 113, 141, 169
Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)
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
Measured: Day 85, Day 169
Change From Baseline in 36-item Short Form Health Survey (SF-36)
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
Measured: Day 85, Day 169
Geometric Mean of Trough Concentration (Cmin) of Abatacept
Geometric mean of trough concentration (Cmin) of abatacept at all measured time points.
Measured: Day 29, 85, 113, 141, 169
Percentage of Participants With a Positive Antibody Response
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).
Measured: Day 85 db, day 169 db, post treatment day 85
Summary of Adverse Events: Double Blind Period
Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
Measured: 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.
Laboratory Marked Abnormalities: Double Blind Period
Laboratory values meeting the marked abnormality criteria
Measured: Day 1 up to first dose of OL abatacept or up to 56 post last dose in double -blind for those not in OL.
Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period
Percentage of participants with at least one positive immunogenicity response On Day 365 (end of Open label treatment period) and day 85 post open label follow up period.
Measured: Day 365, post open label treatment day 85
Summary of Adverse Events: Cumulative Abatacept Period
Percentage of participants with adverse events, deaths, serious adverse events and adverse events leading to discontinuation
Measured: Day 365 and 3 months of follow up approximately 450 Days
Laboratory Marked Abnormalities: Cumulative Abatacept Period
Laboratory values meeting the marked abnormality criteria
Measured: Day 365 and 3 months of follow up approximately 450 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start6 Dec 2016
- Primary completion7 Aug 2018
- Study completion23 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sjogrens DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915159
- Sponsor's protocol ID
- IM101-603
- Other IDs
- 2016-001948-19, 2016
- Status last verified
- Jul 2020
- First submitted
- 23 Sep 2016
- Last updated
- 10 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02915159
- Acronym / sponsor ID
- IM101-603
- Conditions
- Sjogrens Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 23 Jul 2019 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 2 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abatacept | Experimental | Biological: AbataceptAbatacept 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 |
| Placebo | Placebo comparator | Biological: Abatacept, Other: PlaceboPlacebo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptAlso: Orencia, Bristol-Myers Squibb (BMS)-188667 | Biological | Abatacept, Placebo |
| Placebo | Other | Placebo |
Primary outcome
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
40 secondary outcomes
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Inde (ESSPRI)
Time frame: Day 169
Change From Baseline in the Stimulated Whole Salivary Flow
Time frame: Day 169
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change From Baseline in Components of ESSDAI
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141 and Day 169
Change From Baseline in ESSPRI Components
Time frame: Day 29, Day 57, Day 85, Day 113, Day 141, Day 169
Change From Baseline in Schirmer's Test
Time frame: Day 85, Day 169
Change From Baseline in the Ocular Staining Score (OSS)
Time frame: Day 85, Day 169
Change From Baseline in Tear Break-up Time
Time frame: Day 85, Day 169
Change From Baseline in Unstimulated Salivary Flow
Time frame: Day 85, Day 169
Change From Baseline in Stimulated Salivary Flow
Time frame: Day 85, Day 169
Change From Baseline in Numeric Rating Scale for Mouth Dryness
Time frame: Day 1, 29, 57, 85, 113, 141, 169
Change From Baseline in Numeric Rating Scale for Eye Dryness
Time frame: Day 1, 29, 57, 85, 113, 141, 169
Change From Baseline in Participant Assessment of Disease Activity
Time frame: Day 29, 57, 85, 113, 141, 169
Change From Baseline in Physician Global Assessment of Disease Activity
Time frame: Day 29, 57, 85, 113, 141, 169
Change From Baseline in Patient Fatigue
Time frame: Day 29, 57, 85, 113, 141, 169
Change From Baseline in Female Sexual Function Using the Female Sexual Function Index (FSFI)
Time frame: Day 85, Day 169
Change From Baseline in 36-item Short Form Health Survey (SF-36)
Time frame: Day 85, Day 169
Geometric Mean of Trough Concentration (Cmin) of Abatacept
Time frame: Day 29, 85, 113, 141, 169
Percentage of Participants With a Positive Antibody Response
Time frame: Day 85 db, day 169 db, post treatment day 85
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.
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.
Percentage of Participants With a Positive Antibody Response in the Cumulative Abatacept Period
Time frame: Day 365, post open label treatment day 85
Summary of Adverse Events: Cumulative Abatacept Period
Time frame: Day 365 and 3 months of follow up approximately 450 Days
Laboratory Marked Abnormalities: Cumulative Abatacept Period
Time frame: Day 365 and 3 months of follow up approximately 450 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
71 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Abatacept in people with Sjogrens Disease, run by Bristol-Myers Squibb at 71 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 71 sites in United States, Japan, France, Argentina, Australia and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI) (time frame: Day 169). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.