Proof of Concept Study to Evaluate the Efficacy and Safet... | NCT02843659

ID	Type	Description	Link
2016-000101-37	EudraCT Number

Status Module

Label	Type	Description	Intervention Names
BMS-931699	Experimental	Subcutaneous weekly injection + daily oral placebo tablets	Drug: BMS-931699 Drug: Placebo
BMS-986142	Experimental	Daily oral tablets + subcutaneous placebo (weekly) injection	Drug: BMS-986142 Drug: Placebo
Placebo	Placebo Comparator	Weekly subcutaneous placebo injection +daily oral placebo tablets	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BMS-931699	Drug	Specified dose on specified days	BMS-931699	lulizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in ESSDAI	The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening	At baseline and week 12

Secondary Outcomes

Measure	Description	Time Frame
Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8	The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening

Eligibility Module

Eligibility Criteria

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

Inclusion Criteria:

Subjects diagnosed or classified as having moderate to severe primary Sjögren's Syndrome based on the 2016 ACR-EULAR Sjögren's Syndrome Classification Criteria for at least 16 weeks prior to screening
ESSDAI ≥ 5 including disease activity (any score > 0) in at least one of the following domains: Glandular, Articular, Hematological, Biological, Lymphadenopathy
Positive anti-SS-A/Ro and/or anti-SS-B/La autoantibody
Unstimulated whole saliva secretion > 0.01 ml/min
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug and must not be pregnant or breastfeeding. Male and female subjects must be willing to adhere to protocol-mandated highly effective contraception for the duration of the study and for the protocol-specified follow up period. Hormone-based contraceptive methods are not permitted

Exclusion Criteria:

Secondary Sjögren's syndrome or the presence of any other systemic autoimmune disease (eg, RA, SLE, multiple sclerosis, vasculitis)
Very severe primary Sjögren's syndrome or severe complications of primary Sjögren's syndrome at the time of the screening visit
Active systemic or latent bacterial (including tuberculosis), viral or fungal infection, evidence of current or chronic Hepatitis B or C infection, or HIV infection
Any significant concurrent medical condition at the time of screening or baseline visit
Use of methotrexate, cyclophosphamide, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil (MMF) or leflunomide within 12 weeks of screening visit
Previous treatment with biologics therapies either marketed or in development within 6 months prior to screening visit
Treatment started or an unstable dose of hydroxychloroquine within 8 weeks of screening visit
Oral corticosteroids > 10 mg/day within 14 days of dosing (Day 1), corticosteroid therapy ≥ 1 mg/kg during the 4 weeks preceding enrollment, or intravenous, intramuscular or intra-articular corticosteroids within 4 weeks of screening visit

Other protocol defined inclusion/exclusion criteria could apply

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
St Joseph Heritage Healthcare		Fullerton	California	92835	United States
Local Institution

Label	URL
BMS Clinical Trial Patient Recruiting	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
FG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Feb 13, 2017	Jul 24, 2018

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Mean Change From Baseline in ESSDAI

The ESSDAI is a clinical index that measures Sjogren's syndrome disease activity. A physician scores the disease activity level of twelve organ-specific domains in 3 or 4 levels according to their severity. For example, for no disease activity the domain score equals 0 and for high disease activity the domain score equals 3 or 4. Each domain is assigned a weight between 1 and 6, and the domain score is multiplied by the domain weight. The sum of the weighted domain scores is the overall score, which can range from 0 to 123. A higher score indicates more disease activity. Change from baseline was computed as the value at Week 24 minus the baseline value. A negative value in change from baseline indicates an improvement and a positive value indicates worsening

The study was terminated and data is not reported for privacy reasons

Posted

At baseline and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants	OG0000 OG0010 OG0020

Secondary

Mean Change From Baseline in ESSDAI Scores at Week 4 and Week 8

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4 and week 8

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Secondary

Mean Change From Baseline in ESSPRI Score at Week 4, Week 8, and Week 12.

ESSPRI, also known as EULAR Sjogren's Syndrome Patient Reported Index, measures subjective symptoms of dryness, pain and fatigue. It uses 0-10 numerical scales, one for each domain. The weight of the domains is identical, and the final score is the mean score of the 3 domains.

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Proportion of Subjects With a > = 3 Point Improvement From Baseline in ESSDAI at Week 12

The study was terminated and data is not reported for privacy reasons

Posted

At week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Secondary

Proportion of Subjects With Both >= 3 Points Improvement in ESSDAI and >= 1 Point Improvement in ESSPRI From Baseline at Week 12

The study was terminated and data is not reported for privacy reasons

Posted

At week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Secondary

Proportions of Subjects With >=1 Point of Improvement From Baseline in ESSPRI

The study was terminated and data is not reported for privacy reasons

Posted

At week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change in Baseline in ESSPRI Individual Component of Dryness

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change in Baseline in ESSPRI Individual Component of Fatigue

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change in Baseline in ESSPRI Individual Component of Pain

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change From Baseline in Unstimulated Salivary Flow Rate

Serum and saliva biomarkers (collected from samples obtained during unstimulated and stimulated salivary flow assessments) were measured to determine the potential PD effect of BMS-931699 and BMS-986142 on disease-related protein analytes. These assessments included, but were not limited to, the detection of cytokines and other protein analytes by immunoassays and/or mass spectrometry proteomic profiling.

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts

Secondary

Mean Change From Baseline in Stimulated Salivary Flow Rate

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts

Secondary

Mean Change From Baseline in Ocular Surface Staining

The test was performed by instillation of fluorescein dye and either lissamine green or Rose bengal dye to stain the cornea and conjunctiva, respectively. After instilling the dye, the ocular surface was examined through a slit lamp (biomicroscope).

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change From Baseline in Schrimer's Test

The test (without anaesthesia) was performed by placing a narrow calibrated filter-paper strip in the inferior cul-de-sac of each eye. Aqueous tear production was measured by the length in millimeters that the strip wets during the 5 minute test period

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change From Baseline in the Tear Break-up Time Test

Determined by instilling fluorescein dye and evaluating the stability of the pre-corneal tear film. After several blinks, the tear film is examined using a broad beam of the slit-lamp (biomicroscope) with a cobalt blue filter. The TBUT, defined as the time in seconds between the subjects's last blink and the first appearance of a random dry spot on the corneal surface, is measured 3 times and the mean value is recorded.

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, and week 12

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts

Secondary

Mean Change From Baseline in Numeric Rating Scale (NRS) for Mouth, Eye and Vaginal Dryness

The Numeric Rating Scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 = No Pain, 1-3 = Mild Pain(nagging, annoying, interfering little with ADLs), 4-6 = Moderate Pain (interferes significantly with ADLs), 7-10 = Severe Pain (disabling; unable to perform ADLs)

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, at week 2, week 4, week 6, week 8, week 10, week 12, and week 18

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change From Baseline in Subject Global Assessment of Disease Activity (SubGDA)

The subjects overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants	OG000

Secondary

Mean Change Form Baseline in Physician Global Assessment of Disease Activity (phyGDA)

The investigator's or physician's overall assessment of disease activity from 0-10 cm VAS scale with 0 being no disease and 10 cm being most severe disease.

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 2, week 4, week 6, week 8, week 10, week 12, and week 18

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change From Baseline in Short Form-36 (SF-36)

First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores. Table 2 lists the items averaged together to create each scale. Items that are left blank(missing data) are not taken into account when calculating the scale scores. Hence, scale scores represent the average for all items in the scale that the respondent answered

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, week 12, and week 18

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Secondary

Mean Change From Baseline in Female Sexual Function Index (FSFI)

The Female Sexual Function Index (FSFI), a 19-item questionnaire, has been developed as a brief, multidimensional self-report instrument for assessing the key dimensions of sexual function in women

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, week 12, and week 18

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Secondary

Mean Change From Baseline in Work Participation and Activity Impairment Questionnaire (WPAI)

Affords calculation of 4 scales to measure the impact of IBD on different domains of impairment in work or other activities: absenteeism, presenteeism (impairment at work), productivity loss (overall work impairment), activity impairment

The study was terminated and data is not reported for privacy reasons

Posted

At baseline, week 4, week 8, week 12, and week 18

ID	Title	Description
OG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
OG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
OG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0021 events1 affected6 at risk
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected7 at risk EG0011 events1 affected5 at risk EG0020 affected6 at risk
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk
Gastroenteritis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Influenza	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Soft tissue infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Injection site haematoma	General disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk
Injection site reaction	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Pain	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Sensation of foreign body	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Alanine aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0022 events1 affected6 at risk
Anticoagulation drug level above therapeutic	General disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Blood pressure increased	Investigations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Gastritis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Vitamin B12 deficiency	Metabolism and nutrition disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected7 at risk EG0010 events0 affected5 at risk EG0020 events0 affected6 at risk
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Depression	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0010 events0 affected5 at risk EG0021 events1 affected6 at risk
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected7 at risk EG0011 events1 affected5 at risk EG0020 events0 affected6 at risk

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Subjects received subcutaneous (SC) injection of placebo matched to 12.5 milligram (mg) lulizumab (BMS-931699) weekly (QW) and oral tablets of placebo matched to 350 mg BMS-986142 once daily (QD) for 12 weeks.	7	0	7	2	7
EG001	Lulizumab (BMS-931699) 12.5mg QW	Subjects received SC injection of 12.5 mg lulizumab (BMS-931699) QW and oral tablets of placebo matched to 350 mg BMS-986142 QD for 12 weeks.	5	0	5	4	5
EG002	BMS-986142 350 mg QD	Subjects received oral tablets of 350 mg BMS-986142 QD and placebo matched to SC injection of 12.5 mg lulizumab (BMS-931699) QW for 12 weeks.	6	1	6	4	6

ID	Term
D001172	Arthritis, Rheumatoid
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D014987	Xerostomia
D012466	Salivary Gland Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D015352	Dry Eye Syndromes
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Title	Description
BG000	BMS-931699/Lulizumab Injection	(12.5mg/vial, 12.5mg/mL) for subcutaneous (SC)
BG001	BMS-986142 50 mg Tablet (Round) or 150 mg Tablet (Oval)	For oral administration, 350 mg
BG002	Placebo	For BMS-986142 50 mg tablet (round) or 150 mg tablet
BG003	Total	Total of all reporting groups