Trial Outcomes & Findings for A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy (NCT NCT02277444)
NCT ID: NCT02277444
Last Updated: 2025-11-14
Results Overview
Serum golimumab trough concentration at Week 28 was reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
130 participants
Primary outcome timeframe
Week 28
Results posted on
2025-11-14
Participant Flow
Participant milestones
| Measure |
Golimumab
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
|
|---|---|
|
Treatment Period (Week 0-52)
STARTED
|
130
|
|
Treatment Period (Week 0-52)
Treated
|
127
|
|
Treatment Period (Week 0-52)
COMPLETED
|
112
|
|
Treatment Period (Week 0-52)
NOT COMPLETED
|
18
|
|
LTE Period (Week 52 to Week 252)
STARTED
|
112
|
|
LTE Period (Week 52 to Week 252)
COMPLETED
|
69
|
|
LTE Period (Week 52 to Week 252)
NOT COMPLETED
|
43
|
|
ETP Period (Week 252 to Week 420)
STARTED
|
32
|
|
ETP Period (Week 252 to Week 420)
COMPLETED
|
18
|
|
ETP Period (Week 252 to Week 420)
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Golimumab
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
|
|---|---|
|
Treatment Period (Week 0-52)
Adverse Event
|
11
|
|
Treatment Period (Week 0-52)
Withdrawal by Subject
|
3
|
|
Treatment Period (Week 0-52)
Other
|
1
|
|
Treatment Period (Week 0-52)
Enrolled and not Treated
|
3
|
|
LTE Period (Week 52 to Week 252)
Other
|
43
|
|
ETP Period (Week 252 to Week 420)
Adverse Event
|
1
|
|
ETP Period (Week 252 to Week 420)
Physician Decision
|
3
|
|
ETP Period (Week 252 to Week 420)
Withdrawal by Subject
|
2
|
|
ETP Period (Week 252 to Week 420)
Other
|
8
|
Baseline Characteristics
A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
Baseline characteristics by cohort
| Measure |
Golimumab
n=127 Participants
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
|
|---|---|
|
Age, Continuous
|
11.6 years
STANDARD_DEVIATION 3.85 • n=10 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
4 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Other
|
28 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White
|
85 Participants
n=10 Participants
|
|
Region of Enrollment
ARGENTINA
|
18 Participants
n=10 Participants
|
|
Region of Enrollment
BRAZIL
|
16 Participants
n=10 Participants
|
|
Region of Enrollment
CANADA
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
CHILE
|
7 Participants
n=10 Participants
|
|
Region of Enrollment
ISRAEL
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
MEXICO
|
25 Participants
n=10 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
14 Participants
n=10 Participants
|
|
Region of Enrollment
SOUTH AFRICA
|
15 Participants
n=10 Participants
|
|
Region of Enrollment
UNITED STATES
|
23 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 28Population: The pharmacokinetic (PK) analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Serum golimumab trough concentration at Week 28 was reported.
Outcome measures
| Measure |
Golimumab
n=87 Participants
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
|
|---|---|
|
Serum Trough Concentration (C-trough) of Golimumab
|
0.50 micrograms per milliliter (mcg/mL)
Standard Deviation 0.427
|
PRIMARY outcome
Timeframe: Week 28Population: The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.
AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
Outcome measures
| Measure |
Golimumab
n=127 Participants
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
|
|---|---|
|
Bayesian Area Under Curve at Steady State (AUCss) Over an 8-week Dosing Interval at Week 28
|
399 micrograms*day/milliliter (mcg*day/mL)
Interval 387.0 to 424.0
|
SECONDARY outcome
Timeframe: Week 52Population: The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Serum golimumab trough concentration at Week 52 was reported.
Outcome measures
| Measure |
Golimumab
n=95 Participants
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
|
|---|---|
|
Serum Trough Concentration (C-trough) at Week 52
|
0.52 mcg/mL
Standard Deviation 0.475
|
SECONDARY outcome
Timeframe: Week 52Population: The PK analysis set included all treated participants (who received at least 1 infusion) who have sufficient PK samples for analysis.
AUCss was defined as area under the plasma concentration-time curve at steady-state (based on steady-state assessment of trough concentrations or via modeling).
Outcome measures
| Measure |
Golimumab
n=127 Participants
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase. Participants who opted not to enter the LTE completed an additional 8-week safety follow-up visit following the last administration of the study agent. Participants who entered LTE continued to receive 80 mg/m\^2 IV golimumab q8w through Week 244. All participants who completed Week 244 were followed for safety through Week 252. Participants who met the inclusion criteria entered the extended treatment period (ETP) and continued to receive 80 mg/m\^2 IV golimumab q8w from Week 252 to Week 420.
|
|---|---|
|
Baysesian Area Under Curve at Steady State (AUCss) at Week 52
|
421 mcg*day/mL
Interval 402.0 to 446.0
|
Adverse Events
Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w
Serious events: 9 serious events
Other events: 74 other events
Deaths: 1 deaths
LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w
Serious events: 18 serious events
Other events: 57 other events
Deaths: 1 deaths
ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w
n=127 participants at risk
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase.
|
LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w
n=127 participants at risk
Participants who completed Week 52 and entered into the LTE phase, continued to receive 80 mg/m\^2 intravenous golimumab every 8 weeks through Week 244. Those who chose not to enter LTE completed an additional 8-week safety follow-up visit after their final administration of the study agent. All participants who completed Week 244 were monitored for safety through Week 252.
|
ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w
n=32 participants at risk
Participants who met the inclusion criteria entered the ETP and continued receiving 80 mg/m\^2 intravenous golimumab every 8 weeks from Week 252 to Week 420.
|
|---|---|---|---|
|
Cardiac disorders
Myopericarditis
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Eye disorders
Glaucoma
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
General disorders
Calcinosis
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
3.1%
1/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
General disorders
Drug Intolerance
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
General disorders
Ocular Implant Exposure
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
3.1%
1/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
General disorders
Temperature Regulation Disorder
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
3.1%
1/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Cellulitis
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Disseminated Tuberculosis
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Escherichia Infection
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Furuncle
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Herpes Zoster Disseminated
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Infective Exacerbation of Bronchiectasis
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Pneumonia
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Sepsis
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Varicella
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cutaneous T-Cell Lymphoma
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Psychiatric disorders
Generalised Anxiety Disorder
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Psychiatric disorders
Major Depression
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Psychiatric disorders
Suicidal Ideation
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Vascular disorders
Cyanosis
|
0.00%
0/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
Other adverse events
| Measure |
Treatment Period (Week 0 to 52): Golimumab 80 mg/m^2 IV q8w
n=127 participants at risk
Participants received 80 milligrams per meter square (mg/m\^2) golimumab as an intravenous (IV) infusion at Weeks 0, 4, and then every 8 weeks (q8w) till Week 52. Participants also received commercial methotrexate (MTX) weekly through Week 28 at the same body surface area (BSA)-based dosage (10 to 30 mg/m\^2 per week for participants with BSA less than \[\<\] 1.67 meter square \[m\^2\], or minimum of 15 mg/week for participants with BSA greater than or equal to \[\>=\] 1.67 m\^2) as at time of study entry. After Week 28, changes in MTX administration were permitted. Participants who completed Week 52 had the option to enter into the long-term extension (LTE) phase.
|
LTE Period (Week 52 to 252): Golimumab 80 mg/m^2 IV q8w
n=127 participants at risk
Participants who completed Week 52 and entered into the LTE phase, continued to receive 80 mg/m\^2 intravenous golimumab every 8 weeks through Week 244. Those who chose not to enter LTE completed an additional 8-week safety follow-up visit after their final administration of the study agent. All participants who completed Week 244 were monitored for safety through Week 252.
|
ETP (Week 252 to 420): Golimumab 80 mg/m^2 IV q8w
n=32 participants at risk
Participants who met the inclusion criteria entered the ETP and continued receiving 80 mg/m\^2 intravenous golimumab every 8 weeks from Week 252 to Week 420.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
6.3%
8/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
1.6%
2/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Gastrointestinal disorders
Nausea
|
8.7%
11/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
5.5%
7/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
10/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
3.9%
5/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Gastroenteritis
|
4.7%
6/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
9.4%
12/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
3.1%
1/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Nasopharyngitis
|
17.3%
22/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
12.6%
16/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
6.2%
2/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Pharyngitis
|
3.1%
4/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
6.3%
8/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
22.0%
28/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
15.0%
19/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
3.1%
1/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Infections and infestations
Urinary Tract Infection
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
9.4%
12/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Investigations
Alanine Aminotransferase Increased
|
5.5%
7/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.79%
1/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
0.00%
0/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Nervous system disorders
Arthritis
|
3.1%
4/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
5.5%
7/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
9.4%
3/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Musculoskeletal and connective tissue disorders
Juvenile Idiopathic Arthritis
|
11.0%
14/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
14.2%
18/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
6.2%
2/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
|
Nervous system disorders
Headache
|
11.0%
14/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
4.7%
6/127 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
3.1%
1/32 • Treatment Period Arm: All cause mortality (From screening [-6 weeks] up to Week 52), Serious and Other AEs (Week 0 up to Week 52); LTE Period Arm: Week 52 up to Week 252; ETP Arm: Week 252 up to Week 420
All Cause mortality reported for all randomized participants. Serious and other AEs: The full analysis set includes all enrolled participants who received at least 1 infusion.
|
Additional Information
Senior Director Clinical Development
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER