A Study of SIMPONI® to Arrest Beta-cell Loss in Type 1 Di... | NCT02846545

NCT02846545

ID	Type	Description	Link
CNTO148DML2001	Other Identifier	Janssen Research & Development, LLC
2021-000189-13	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1: Golimumab	Experimental	Participants will receive subcutaneous (SC) golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may enter in an open-label (OL) extension period to receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area).	Biological: Golimumab
Group 2: Placebo	Placebo Comparator	Participants will receive a matching placebo to golimumab.	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Golimumab	Biological	Participants will receive subcutaneous golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area) in an OL extension period.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52	MMTT-Stimulated 4-Hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.	Week 52

Secondary Outcomes

Measure	Description	Time Frame
Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day	Change from baseline in daily insulin use at Week 52 was reported.	Baseline and Week 52
Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Double-blind Period:

Be positive for at least 1 of the following diabetes-related autoantibodies obtained at study screening: Glutamic acid decarboxylase (GAD-65), islet antigen 2 (IA-2), zinc transporter 8 (ZnT8), Islet Cell Cytoplasmic Autoantibodies (ICA), or Insulin (if obtained within 10 days of the onset of exogenous insulin therapy)
Have a peak stimulated C-peptide level greater than or equal to (>=) 0.2 picomole per milliliter (pmol/mL) following a 4-hour Mixed-meal Tolerance Test (MMTT) obtained at study screening
Be medically stable on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population
Females of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) test at screening and a negative urine pregnancy test at the Week 0 visit
Participants (or their legally acceptable representatives) are willing and able to adhere to requirements, prohibitions, and restrictions specified in this protocol

Open-Label Extension Period:

- Participants must meet the responder criteria based on C-peptide area under the concentration-time curve (AUC) and insulin dose-adjusted HbA1c (IDAAC) remission score

Exclusion Criteria:

Double-blind Period:

Has a history of significant renal, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease or immune suppression or immune deficiency.
Has significant cardiovascular disease, including history of myocardial infarction, congestive heart failure, angina, abnormal electrocardiogram or abnormal stress test
Has active infections, is prone to infections or has chronic, recurrent or opportunistic infectious disease, including but not limited to, chronic renal infection, chronic chest infection (example [eg.], bronchiectasis), sinusitis, recurrent urinary tract infection (eg., recurrent pyelonephritis, chronic cystitis), Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis or an open, draining, or infected non-healing skin wound or ulcer
Has a clinically active infection with Epstein-Barr virus (EBV) or an EBV viral load >=10,000 copies per milliliter (mL) of plasma obtained at study screening. Has a clinically active infection with cytomegalovirus (CMV) or a CMV viral load >= 10,000 copies per milliliter (mL) of plasma obtained at study screening
Current or prior (within 30 days of screening) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including high-dose inhaled, extensive topical, or systemic glucocorticoids
Has another autoimmune disease (eg, rheumatoid arthritis [RA], polyarticular juvenile idiopathic arthritis [pJIA], psoriatic arthritis [PsA], ankylosing spondylitis [AS], multiple sclerosis [MS], systemic lupus erythematosus [SLE], celiac disease [clinically symptomatic and antibody positive, that is, tissue transglutaminase Immunoglobulin A [IgA]) excluding clinically stable autoimmune thyroiditis whether treated or untreated
Has any of the following tuberculosis [TB] screening criteria: A history of latent or active TB prior to screening (including but not limited to a positive QuantiFERON®-TB Gold test), signs or symptoms suggestive of active TB upon medical history and/or physical examination, recent close contact with a person with known or suspected active TB
Has known allergies, intolerance and/or hypersensitivity to human immunoglobulin proteins, golimumab or any of its components or its excipients

Open-Label Extension Period:

Participants having reported clinically significant AEs or serious adverse events (SAEs) deemed to be related to the study agent during the double blind period (for example. severe infections or hypersensitivity reactions), precluding renewed exposure to golimumab
Participants who discontinued study agent administration prior to Week 52 or who have completed the Week 104 visit of the double-blind period or discontinued early from study](streamdown:incomplete-link)

Contacts/Locations Module

Name	Affiliation	Role
Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33207093	Derived	Quattrin T, Haller MJ, Steck AK, Felner EI, Li Y, Xia Y, Leu JH, Zoka R, Hedrick JA, Rigby MR, Vercruysse F; T1GER Study Investigators. Golimumab and Beta-Cell Function in Youth with New-Onset Type 1 Diabetes. N Engl J Med. 2020 Nov 19;383(21):2007-2017. doi: 10.1056/NEJMoa2006136.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 23, 2019	May 18, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG00028 subjects
FG00156 subjects

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
BG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00013.5± 4.01 BG00113.3± 3.73 BG00213.4± 3.8

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Children (2-11 years)	BG0008 BG00120 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00010 BG00125 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

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

Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) at Week 52

MMTT-Stimulated 4-Hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.

Full Analysis Set (FAS) included all randomized participants who took at least one dose (complete or partial) of study agent. Here 'N' (number of participants analyzed) included all participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

picomoles per milliliter (pmol/mL)

Week 52

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Units	Counts
Participants	OG00025 OG00150

Title

Denominators

Categories

Title	Measurements
	OG0000.43± 0.388(0.388 to ) OG0010.64± 0.423(0.423 to )

Secondary

Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day

Change from baseline in daily insulin use at Week 52 was reported.

FAS included all randomized participants who took at least one dose (complete or partial) of study agent. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

units/kilogram/day

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52

Change from baseline in glycosylated HbA1c at Week 52 was reported.

Posted

Mean

Standard Deviation

HbA1C percent (%)

Baseline and Week 52

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Hypoglycemic Event Rates

A hypoglycemic event was defined as either a biochemically confirmed hypoglycemic episode or a severe hypoglycemic event. The hypoglycemia event rate (number of hypoglycemia episodes per patient-year) was defined as blood glucose levels of less than and equal to (<=) 70, 55, and 35 mg/dL or clinical sequelae consistent with severe hypoglycemia in the absence of a BG reading.

FAS which had all randomized participants who took at least one dose (complete or partial) of study agent.

Posted

Number

events per patient-year

Up to Week 52

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time

MMTT-Stimulated 4-Hour C-peptide AUC is the mean area under the C-peptide level-time curve over the 4-hour period divided by the duration after a mixed-meal tolerance test.

FAS included all randomized participants who took at least one dose (complete or partial) of study agent. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.

Posted

Mean

Standard Deviation

pmol/mL

Baseline, Weeks 12, 26, 38, 52, 78 and 104

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

An adverse event (AE) was defined as any untoward medical occurrence in clinical study subject administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. Treatment emergent AEs were defined as AEs with onset during the treatment phase or that are a consequence of a pre-existing condition that has worsened since baseline.

The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population.

Posted

Number

percentage of participants

Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Percentage of Participants With Serious Adverse Events

An AE was defined as any untoward medical occurrence in clinical study participant administered medicinal product. It could be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. A serious AE was defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious treatment via medicinal product and was medically important.

The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population.

Posted

Number

percentage participants

Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab

Secondary

Percentage of Participants With Severe Infections Through Week 52 and Week 104

Participants having 1 or more severe infections were evaluated and reported.

The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population.

Posted

Number

percentage of participants

Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Active Treatment Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52

Percentage of participants with study agent injection site reactions up to Week 52 were reported.

The safety analysis set included all randomized participants who received at least 1 (partial or complete) dose of study agent, that is, the treated population.

Posted

Number

percentage of participants

Up to Week 52

ID	Title	Description
OG000	Placebo	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week (Wk) 0 through Week 52 to match the active arm. Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up [FU] period).
OG001	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Serum Golimumab Concentrations

Serum samples were collected for the measurement of golimumab concentrations.

PK Analysis Set included all participants who received at least 1 golimumab injection and had sufficient PK samples for analysis. Here 'n' (number analyzed) included all participants who were analyzed at specified timepoints.

Posted

Mean

Standard Deviation

micrograms per milliliter (mcg/mL)

Preinjection: Week 0, Week 2, Week 4, Week 8, Week 12, and Week 26, Week 33, Week 38 (preinjection),Week 45 and Week 52 (preinjection), for active treatment period; Weeks 78 and 104 for Off-therapy follow-up period

ID	Title	Description
OG000	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Number of Participants With Antibodies to Golimumab

Number of participants with antibodies to golimumab were reported.

PK Analysis Set included all participants with appropriate samples (had 1 or more samples) obtained after their first study agent administration.

Posted

Count of Participants

Participants

Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

ID	Title	Description
OG000	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Secondary

Titers of Antibodies to Golimumab

Titers of antibodies to golimumab were evaluated.

PK Analysis Set included all the participants who were antibody positive, the peak titers for them were evaluated. Data was not collected and analyzed for this outcome measure due to change in planned analysis.

Posted

Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)

ID	Title	Description
OG000	Golimumab	Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Active Treatment Period: Placebo (Week 0 - 52)	Participants in the active treatment period received a subcutaneous (SC) injection of placebo every 2 weeks (q2w) from Week 0 through Week 52 to match the active arm.	28	1	28	21	28
EG001	Active Treatment Period: Golimumab (Week 0 - 52)	Participants in the active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52.	56	1	56	45	56
EG002	Off-therapy Follow Up Period: Placebo (Week 52 - 104)	Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up period).	25	1	25	14	25
EG003	Off-therapy Period: Golimumab (Week 52 - 104)	Following the 52-week active treatment period, participants were monitored for an additional 52 weeks for safety (off-therapy follow-up period) and did not receive the study drug during this period (off-therapy follow-up period).	49	4	49	26	49
EG004	OLE Period: Golimumab (OLE Week 0-60 After Active Treatment Period)	Following the active treatment period, participants were assessed for response at Week 52 and and those who were responders and still in the off-therapy follow-up period were offered the option to enter the open-label extension (OLE) period. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in the off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.	5	1	5	3	5

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diplopia	Eye disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0011 events1 affected56 at risk EG0020 events0 affected25 at risk EG0030 events0 affected49 at risk EG0040 events0 affected5 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003
Diabetic Ketoacidosis	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected56 at risk EG0021 events1 affected25 at risk EG003
Seizure	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0012 events2 affected56 at risk EG0020 events0 affected25 at risk EG0031 events1 affected49 at risk EG0040 events0 affected5 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0014 events3 affected56 at risk EG0020 events0 affected25 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0013 events3 affected56 at risk EG0020 events0 affected25 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0003 events3 affected28 at risk EG0013 events3 affected56 at risk EG0020 events0 affected25 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected28 at risk EG0015 events5 affected56 at risk EG0020 events0 affected25 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0017 events5 affected56 at risk EG0021 events1 affected25 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0015 events5 affected56 at risk EG0020 events0 affected25 at risk EG003
Fatigue	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected28 at risk EG0013 events3 affected56 at risk EG0020 events0 affected25 at risk EG003
Injection Site Erythema	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0004 events3 affected28 at risk EG00136 events9 affected56 at risk EG0020 events0 affected25 at risk EG003
Injection Site Pain	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG00111 events6 affected56 at risk EG0020 events0 affected25 at risk EG003
Injection Site Swelling	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG00114 events4 affected56 at risk EG0020 events0 affected25 at risk EG003
Injection Site Urticaria	General disorders	MedDRA 23.0	Non-systematic Assessment	EG00013 events3 affected28 at risk EG0014 events2 affected56 at risk EG0020 events0 affected25 at risk EG003
Pyrexia	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected28 at risk EG0015 events4 affected56 at risk EG0020 events0 affected25 at risk EG003
Seasonal Allergy	Immune system disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0016 events6 affected56 at risk EG0021 events1 affected25 at risk EG003
Bronchitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0013 events3 affected56 at risk EG0021 events1 affected25 at risk EG003
Ear Infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected28 at risk EG0010 events0 affected56 at risk EG0022 events2 affected25 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0016 events5 affected56 at risk EG0020 events0 affected25 at risk EG003
Influenza	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0016 events6 affected56 at risk EG0022 events2 affected25 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0008 events5 affected28 at risk EG00116 events10 affected56 at risk EG0024 events3 affected25 at risk EG003
Otitis Media	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0003 events2 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003
Pharyngitis Streptococcal	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0014 events3 affected56 at risk EG0020 events0 affected25 at risk EG003
Sinusitis	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0015 events4 affected56 at risk EG0020 events0 affected25 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG00011 events9 affected28 at risk EG00131 events17 affected56 at risk EG0024 events4 affected25 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0004 events2 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003
Limb Injury	Injury, poisoning and procedural complications	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0013 events3 affected56 at risk EG0020 events0 affected25 at risk EG003
Glycosylated Haemoglobin Increased	Investigations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 23.0	Non-systematic Assessment	EG00063 events2 affected28 at risk EG001104 events14 affected56 at risk EG00290 events2 affected25 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0014 events3 affected56 at risk EG0020 events0 affected25 at risk EG003
Headache	Nervous system disorders	MedDRA 23.0	Non-systematic Assessment	EG0004 events3 affected28 at risk EG00127 events11 affected56 at risk EG0021 events1 affected25 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0013 events3 affected56 at risk EG0020 events0 affected25 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG00010 events8 affected28 at risk EG00110 events9 affected56 at risk EG0021 events1 affected25 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0006 events4 affected28 at risk EG0019 events5 affected56 at risk EG0021 events1 affected25 at risk EG003
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0001 events1 affected28 at risk EG0018 events8 affected56 at risk EG0020 events0 affected25 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 23.0	Non-systematic Assessment	EG0002 events2 affected28 at risk EG0011 events1 affected56 at risk EG0021 events1 affected25 at risk EG003
Viral Infection	Infections and infestations	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003
Medical device site pain	General disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003
Throat tightness	Respiratory, thoracic and mediastinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 23.0	Non-systematic Assessment	EG0000 events0 affected28 at risk EG0010 events0 affected56 at risk EG0020 events0 affected25 at risk EG003

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
C529000	golimumab

Participants in active treatment period weighing less than (<) 45 kilograms (kg) received an induction dose of golimumab 60 milligrams/ meter square (mg/m^2) SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 4 and q2w through Week 52. Participants weighing greater than and equal to (>=45) kg received an induction dose of golimumab 100 mg SC injection at Weeks 0 and 2 followed by a maintenance dose of golimumab 50 mg SC injection at Week 4 and q2w through Week 52. Following 52-week active treatment period, participants were monitored for an additional 52 weeks for safety and did not receive study drug during this period (off-therapy follow-up period). Participants were assessed for response at Week 52 and those who were responders and still in the off-therapy follow-up period were offered option to enter open-label extension (OLE) period after active treatment period, if eligibility criteria were met. Participants weighing <45 kg received a maintenance dose of golimumab 30 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. Participants weighing >=45 kg received maintenance dose of golimumab 50 mg/m^2 SC injection at Week 0 and q2w thereafter through OLE Week 52. After OLE Week 52, participants were followed up for safety up to OLE Week 60. Non-responders at Week 52 continued in off-therapy follow-up period in which they were monitored for safety for additional 52 weeks and did not receive study drug.

EG0040 events0 affected5 at risk

EG0041 events1 affected5 at risk

EG0040 events0 affected5 at risk

EG0041 events1 affected5 at risk

EG0040 events0 affected5 at risk

EG0049 events2 affected5 at risk

EG0040 events0 affected5 at risk

EG0041 events1 affected5 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Little Rock	Arkansas		United States