Diabetes Mellitus, Type 1
Conditions
Brief summary
The primary purpose of this study is to determine if golimumab can preserve beta-cell function in children and young adults with newly diagnosed Type 1 Diabetes (T1D).
Interventions
BIOLOGICALGolimumab
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.
BIOLOGICALPlacebo
Matching Placebo to golimumab.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52 | Baseline and Week 52 | Change from baseline in glycosylated HbA1c at Week 52 was reported. |
| Hypoglycemic Event Rates | Up to Week 52 | 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. |
| Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Baseline, Weeks 12, 26, 38, 52, 78 and 104 | 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. |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) | 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. |
| Percentage of Participants With Serious Adverse Events | Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) | 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. |
| Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day | Baseline and Week 52 | Change from baseline in daily insulin use at Week 52 was reported. |
| Active Treatment Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52 | Up to Week 52 | Percentage of participants with study agent injection site reactions up to Week 52 were reported. |
| Serum Golimumab Concentrations | 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 | Serum samples were collected for the measurement of golimumab concentrations. |
| Number of Participants With Antibodies to Golimumab | Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) | Number of participants with antibodies to golimumab were reported. |
| Titers of Antibodies to Golimumab | Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) | Titers of antibodies to golimumab were evaluated. |
| Percentage of Participants With Severe Infections Through Week 52 and Week 104 | Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period) | Participants having 1 or more severe infections were evaluated and reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 28 |
| 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. | 56 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active Treatment Period: Week 0-52 | Lost to Follow-up | 1 | 1 |
| Active Treatment Period: Week 0-52 | Non-compliance with study drug | 1 | 0 |
| Active Treatment Period: Week 0-52 | Withdrawal by Subject | 1 | 5 |
| Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 | Lost to Follow-up | 1 | 1 |
| Off-therapy FU:Wk 52-104 & OLE: Wk 0-60 | Other | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo | Golimumab | Total |
|---|---|---|---|
| Age, Continuous | 13.5 years STANDARD_DEVIATION 4.01 | 13.3 years STANDARD_DEVIATION 3.73 | 13.4 years STANDARD_DEVIATION 3.8 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 13 Participants | 27 Participants | 40 Participants |
| Age, Customized Adults (18-64 years) | 7 Participants | 9 Participants | 16 Participants |
| Age, Customized Children (2-11 years) | 8 Participants | 20 Participants | 28 Participants |
| Age, Customized From 65 to 84 years | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 51 Participants | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 5 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 46 Participants | 72 Participants |
| Sex: Female, Male Female | 10 Participants | 25 Participants | 35 Participants |
| Sex: Female, Male Male | 18 Participants | 31 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 56 | 0 / 25 | 0 / 49 | 0 / 5 |
| other Total, other adverse events | 21 / 28 | 45 / 56 | 14 / 25 | 26 / 49 | 3 / 5 |
| serious Total, serious adverse events | 1 / 28 | 1 / 56 | 1 / 25 | 4 / 49 | 1 / 5 |
Outcome results
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.
Time frame: Week 52
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | 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 | 0.43 picomoles per milliliter (pmol/mL) | Standard Deviation 0.388 |
| Golimumab | 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 | 0.64 picomoles per milliliter (pmol/mL) | Standard Deviation 0.423 |
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.
Time frame: Baseline and Week 52
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52 | 0.61 HbA1C percent (%) | Standard Deviation 1.368 |
| Golimumab | Active Treatment Period: Change From Baseline in Glycosylated Haemoglobin (HbA1c) at Week 52 | 0.35 HbA1C percent (%) | Standard Deviation 1.851 |
p-value: =0.80295% CI: [-0.81, 0.63]Mixed Models Analysis
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.
Time frame: Baseline and Week 52
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day | 0.239 units/kilogram/day | Standard Deviation 0.2225 |
| Golimumab | Active Treatment Period: Change From Baseline in Insulin Use in Units Per Kilogram Body Weight Per Day | 0.057 units/kilogram/day | Standard Deviation 0.285 |
p-value: =0.000495% CI: [-0.28, -0.08]Mixed Models Analysis
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.
Time frame: Baseline, Weeks 12, 26, 38, 52, 78 and 104
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 104 | 0.25 pmol/mL | Standard Deviation 0.273 |
| Placebo | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 52 | 0.43 pmol/mL | Standard Deviation 0.388 |
| Placebo | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Baseline | 0.88 pmol/mL | Standard Deviation 0.634 |
| Placebo | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 26 | 0.55 pmol/mL | Standard Deviation 0.424 |
| Placebo | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 38 | 0.53 pmol/mL | Standard Deviation 0.423 |
| Placebo | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 78 | 0.31 pmol/mL | Standard Deviation 0.264 |
| Placebo | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 12 | 0.62 pmol/mL | Standard Deviation 0.426 |
| Golimumab | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 52 | 0.64 pmol/mL | Standard Deviation 0.423 |
| Golimumab | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 12 | 0.78 pmol/mL | Standard Deviation 0.355 |
| Golimumab | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 38 | 0.73 pmol/mL | Standard Deviation 0.424 |
| Golimumab | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 26 | 0.76 pmol/mL | Standard Deviation 0.38 |
| Golimumab | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 104 | 0.35 pmol/mL | Standard Deviation 0.36 |
| Golimumab | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Week 78 | 0.45 pmol/mL | Standard Deviation 0.385 |
| Golimumab | Active Treatment Period: C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 4 Hour Mixed Meal Tolerance Test (MMTT) Over Time | Baseline | 0.78 pmol/mL | Standard Deviation 0.396 |
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.
Time frame: Up to Week 52
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Active Treatment Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52 | 28.6 percentage of participants |
| Golimumab | Active Treatment Period: Percentage of Participants With Study Agent Injection Site Reactions Up to Week 52 | 23.2 percentage of participants |
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.
Time frame: Up to Week 52
Population: FAS which had all randomized participants who took at least one dose (complete or partial) of study agent.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Hypoglycemic Event Rates | 43.36 events per patient-year |
| Golimumab | Hypoglycemic Event Rates | 39.01 events per patient-year |
Comparison: Hypoglycemia rate was analyzed by using a Poisson regression model with the number of hypoglycemia events through Week 52 as the response, treatment and gender as fixed factors, age and baseline HbA1c as covariates, and the duration of study participation through week 52 in logarithm as an offset variable.p-value: =0.003695% CI: [0.838, 0.966]Poisson regression model
Secondary
Number of Participants With Antibodies to Golimumab
Number of participants with antibodies to golimumab were reported.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
Population: PK Analysis Set included all participants with appropriate samples (had 1 or more samples) obtained after their first study agent administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Antibodies to Golimumab | Up to Week 52 | 30 Participants |
| Placebo | Number of Participants With Antibodies to Golimumab | Up to Week 104 | 37 Participants |
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.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Serious Adverse Events | Up to Week 52 | 3.6 percentage participants |
| Placebo | Percentage of Participants With Serious Adverse Events | Up to Week 104 | 7.1 percentage participants |
| Golimumab | Percentage of Participants With Serious Adverse Events | Up to Week 52 | 1.8 percentage participants |
| Golimumab | Percentage of Participants With Serious Adverse Events | Up to Week 104 | 8.9 percentage participants |
Secondary
Percentage of Participants With Severe Infections Through Week 52 and Week 104
Participants having 1 or more severe infections were evaluated and reported.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Severe Infections Through Week 52 and Week 104 | Up to Week 104 | 67.9 percentage of participants |
| Placebo | Percentage of Participants With Severe Infections Through Week 52 and Week 104 | Up to Week 52 | 60.7 percentage of participants |
| Golimumab | Percentage of Participants With Severe Infections Through Week 52 and Week 104 | Up to Week 52 | 71.4 percentage of participants |
| Golimumab | Percentage of Participants With Severe Infections Through Week 52 and Week 104 | Up to Week 104 | 75.0 percentage of participants |
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.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Up to Week 52 | 82.1 percentage of participants |
| Placebo | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Up to Week 104 | 89.3 percentage of participants |
| Golimumab | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Up to Week 52 | 91.1 percentage of participants |
| Golimumab | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability | Up to Week 104 | 96.4 percentage of participants |
Secondary
Serum Golimumab Concentrations
Serum samples were collected for the measurement of golimumab concentrations.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Serum Golimumab Concentrations | Week 0 | 0.00 micrograms per milliliter (mcg/mL) | Standard Deviation 0 |
| Placebo | Serum Golimumab Concentrations | Week 2 | 4.64 micrograms per milliliter (mcg/mL) | Standard Deviation 1.506 |
| Placebo | Serum Golimumab Concentrations | Week 4 | 6.85 micrograms per milliliter (mcg/mL) | Standard Deviation 2.168 |
| Placebo | Serum Golimumab Concentrations | Week 8 | 4.67 micrograms per milliliter (mcg/mL) | Standard Deviation 1.93 |
| Placebo | Serum Golimumab Concentrations | Week 12 | 3.74 micrograms per milliliter (mcg/mL) | Standard Deviation 2.032 |
| Placebo | Serum Golimumab Concentrations | Week 26 | 3.37 micrograms per milliliter (mcg/mL) | Standard Deviation 2.011 |
| Placebo | Serum Golimumab Concentrations | Week 33 | 4.41 micrograms per milliliter (mcg/mL) | Standard Deviation 2.825 |
| Placebo | Serum Golimumab Concentrations | Week 38 | 3.06 micrograms per milliliter (mcg/mL) | Standard Deviation 2.127 |
| Placebo | Serum Golimumab Concentrations | Week 45 | 4.44 micrograms per milliliter (mcg/mL) | Standard Deviation 2.828 |
| Placebo | Serum Golimumab Concentrations | Week 52 | 2.89 micrograms per milliliter (mcg/mL) | Standard Deviation 2.022 |
| Placebo | Serum Golimumab Concentrations | Week 78 | 0.00 micrograms per milliliter (mcg/mL) | Standard Deviation 0.007 |
| Placebo | Serum Golimumab Concentrations | Week 104 | 0.00 micrograms per milliliter (mcg/mL) | Standard Deviation 0 |
Secondary
Titers of Antibodies to Golimumab
Titers of antibodies to golimumab were evaluated.
Time frame: Up to Week 52 (Active treatment period), Up to Week 104 (Active treatment + Off therapy follow-up period)
Population: 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.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Titers of Antibodies to Golimumab | Up to Week 52 | — |
| Unknown | Titers of Antibodies to Golimumab | Up to Week 104 | — |