Trial Outcomes & Findings for Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab (NCT NCT02792699)
NCT ID: NCT02792699
Last Updated: 2020-10-06
Results Overview
Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUCinf was estimated using the linear trapezoidal rule.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
311 participants
Primary outcome timeframe
Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.
Results posted on
2020-10-06
Participant Flow
This study was conducted at 57 centers in Bulgaria, Estonia, Germany, Hungary, Poland, and the United States (US). Eligible participants were men and women aged 18 to 80 years, inclusive, with a diagnosis of rheumatoid arthritis (RA) for at least 6 months.
Participants were randomized in a 1:1:1 ratio to 1 of 3 groups, stratified by geographic region (North America vs Eastern Europe vs Western Europe), seropositivity (rheumatoid factor \[RF\]-positive and/or cyclic citrullinated peptide \[CCP\]-positive vs RF-negative and CCP-negative), and number of prior biologic therapies used for RA (1 vs \> 1).
Participant milestones
| Measure |
ABP 798 / ABP 798
Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Rituximab (EU) / Rituximab (EU)
Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Rituximab (US) / ABP 798
Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
|---|---|---|---|
|
Overall Study
STARTED
|
104
|
104
|
103
|
|
Overall Study
Received First Infusion of First Dose
|
104
|
104
|
103
|
|
Overall Study
Received Second Infusion of First Dose
|
102
|
103
|
99
|
|
Overall Study
Received First Infusion of Second Dose
|
97
|
99
|
95
|
|
Overall Study
Received Second Infusion of Second Dose
|
97
|
99
|
93
|
|
Overall Study
COMPLETED
|
95
|
94
|
93
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
10
|
Reasons for withdrawal
| Measure |
ABP 798 / ABP 798
Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Rituximab (EU) / Rituximab (EU)
Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Rituximab (US) / ABP 798
Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
0
|
|
Overall Study
Dissatisfaction with Treatment Efficacy
|
1
|
3
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
Baseline Characteristics
Full analysis set with available data
Baseline characteristics by cohort
| Measure |
ABP 798 / ABP 798
n=104 Participants
Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Rituximab (EU) / Rituximab (EU)
n=104 Participants
Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Rituximab (US) / ABP 798
n=103 Participants
Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Total
n=311 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 10.70 • n=104 Participants
|
56.8 years
STANDARD_DEVIATION 11.34 • n=104 Participants
|
56.4 years
STANDARD_DEVIATION 10.66 • n=103 Participants
|
55.9 years
STANDARD_DEVIATION 10.91 • n=311 Participants
|
|
Age, Customized
< 65 years
|
87 Participants
n=104 Participants
|
74 Participants
n=104 Participants
|
78 Participants
n=103 Participants
|
239 Participants
n=311 Participants
|
|
Age, Customized
≥ 65 years
|
17 Participants
n=104 Participants
|
30 Participants
n=104 Participants
|
25 Participants
n=103 Participants
|
72 Participants
n=311 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=104 Participants
|
91 Participants
n=104 Participants
|
83 Participants
n=103 Participants
|
264 Participants
n=311 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=104 Participants
|
13 Participants
n=104 Participants
|
20 Participants
n=103 Participants
|
47 Participants
n=311 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=104 Participants
|
10 Participants
n=104 Participants
|
11 Participants
n=103 Participants
|
29 Participants
n=311 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=104 Participants
|
94 Participants
n=104 Participants
|
92 Participants
n=103 Participants
|
282 Participants
n=311 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=104 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=311 Participants
|
|
Race/Ethnicity, Customized
White
|
97 Participants
n=104 Participants
|
99 Participants
n=104 Participants
|
91 Participants
n=103 Participants
|
287 Participants
n=311 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=104 Participants
|
3 Participants
n=104 Participants
|
10 Participants
n=103 Participants
|
18 Participants
n=311 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=104 Participants
|
2 Participants
n=104 Participants
|
1 Participants
n=103 Participants
|
3 Participants
n=311 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
2 Participants
n=104 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=103 Participants
|
2 Participants
n=311 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=104 Participants
|
0 Participants
n=104 Participants
|
0 Participants
n=103 Participants
|
0 Participants
n=311 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=104 Participants
|
0 Participants
n=104 Participants
|
1 Participants
n=103 Participants
|
1 Participants
n=311 Participants
|
|
Geographic Region
North America
|
38 Participants
n=104 Participants
|
40 Participants
n=104 Participants
|
39 Participants
n=103 Participants
|
117 Participants
n=311 Participants
|
|
Geographic Region
Eastern Europe
|
59 Participants
n=104 Participants
|
58 Participants
n=104 Participants
|
59 Participants
n=103 Participants
|
176 Participants
n=311 Participants
|
|
Geographic Region
Western Europe
|
7 Participants
n=104 Participants
|
6 Participants
n=104 Participants
|
5 Participants
n=103 Participants
|
18 Participants
n=311 Participants
|
|
Duration of RA
|
11.37 years
STANDARD_DEVIATION 7.400 • n=104 Participants
|
11.69 years
STANDARD_DEVIATION 7.945 • n=104 Participants
|
12.48 years
STANDARD_DEVIATION 9.186 • n=103 Participants
|
11.84 years
STANDARD_DEVIATION 8.194 • n=311 Participants
|
|
Disease Activity Score 28 - C-Reactive Protein (DAS28[CRP])
|
6.09 scores on a scale
STANDARD_DEVIATION 1.035 • n=103 Participants • Full analysis set with available data
|
5.84 scores on a scale
STANDARD_DEVIATION 1.006 • n=102 Participants • Full analysis set with available data
|
6.03 scores on a scale
STANDARD_DEVIATION 0.997 • n=103 Participants • Full analysis set with available data
|
5.99 scores on a scale
STANDARD_DEVIATION 1.015 • n=308 Participants • Full analysis set with available data
|
|
Seropositivity
RF positive and/or CCP positive
|
86 Participants
n=104 Participants
|
88 Participants
n=104 Participants
|
89 Participants
n=103 Participants
|
263 Participants
n=311 Participants
|
|
Seropositivity
RF negative and CCP negative
|
18 Participants
n=104 Participants
|
16 Participants
n=104 Participants
|
14 Participants
n=103 Participants
|
48 Participants
n=311 Participants
|
|
Prior Biologic Use for RA
One
|
62 Participants
n=104 Participants
|
61 Participants
n=104 Participants
|
63 Participants
n=103 Participants
|
186 Participants
n=311 Participants
|
|
Prior Biologic Use for RA
More than one
|
42 Participants
n=104 Participants
|
43 Participants
n=104 Participants
|
40 Participants
n=103 Participants
|
125 Participants
n=311 Participants
|
PRIMARY outcome
Timeframe: Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUCinf data. Participants with unreliable terminal elimination rate constant values were excluded.
Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUCinf was estimated using the linear trapezoidal rule.
Outcome measures
| Measure |
ABP 798
n=94 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=96 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=94 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose
|
149398 h*µg/mL
Geometric Coefficient of Variation 36.2
|
172463 h*µg/mL
Geometric Coefficient of Variation 32.9
|
158529 h*µg/mL
Geometric Coefficient of Variation 34.9
|
—
|
PRIMARY outcome
Timeframe: Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Cmax data on day 15.
Maximum observed concentration following the second infusion of the first dose (day 15). Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=96 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=97 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=93 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Maximum Observed Drug Concentration (Cmax) After the Second Infusion of the First Dose
|
361 µg/mL
Geometric Coefficient of Variation 23.5
|
394 µg/mL
Geometric Coefficient of Variation 22.0
|
372 µg/mL
Geometric Coefficient of Variation 24.7
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUC0-14day data.
Area under the serum concentration-time curve from time 0 on day 1 prior to the first infusion of the first dose to 14 days postdose. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUC0-14day was estimated using the linear trapezoidal rule.
Outcome measures
| Measure |
ABP 798
n=98 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=97 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=93 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Predose on Day 1 to 14 Days Postdose (AUC0-14day)
|
41445 h*µg/mL
Geometric Coefficient of Variation 28.8
|
45161 h*µg/mL
Geometric Coefficient of Variation 24.7
|
43291 h*µg/mL
Geometric Coefficient of Variation 29.6
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hour postdose, and at days 29, 57, and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUC0-12wk data.
Area under the serum concentration-time curve from time 0 on day 1 prior to the first infusion of the first dose to week 12. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method. AUC0-12wk was estimated using the linear trapezoidal rule.
Outcome measures
| Measure |
ABP 798
n=99 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=100 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=96 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Area Under the Serum Concentration-time Curve From Predose on Day 1 to Week 12 (AUC0-12wk)
|
146369 h*µg/mL
Geometric Coefficient of Variation 34.3
|
166995 h*µg/mL
Geometric Coefficient of Variation 30.5
|
155240 h*µg/mL
Geometric Coefficient of Variation 33.7
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Cmax data.
Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=103 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=103 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=99 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Maximum Observed Drug Concentration (Cmax) After the First Infusion of the First Dose
|
298 µg/mL
Geometric Coefficient of Variation 26.1
|
321 µg/mL
Geometric Coefficient of Variation 21.2
|
304 µg/mL
Geometric Coefficient of Variation 25.5
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Tmax data at each time point.
Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=103 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=103 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=99 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Time of Maximum Observed Drug Concentration (Tmax) After the First and Second Infusions of the First Dose
After First Infusion (Day 1)
|
4.50 hours
Interval 4.35 to 7.18
|
4.67 hours
Interval 4.38 to 7.3
|
4.68 hours
Interval 4.38 to 7.5
|
—
|
|
Time of Maximum Observed Drug Concentration (Tmax) After the First and Second Infusions of the First Dose
After Second Infusion (Day 15)
|
3.57 hours
Interval 3.42 to 6.03
|
3.67 hours
Interval 3.4 to 5.5
|
4.12 hours
Interval 3.42 to 6.55
|
—
|
SECONDARY outcome
Timeframe: Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available Clast data.
Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=101 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=103 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=98 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Last Measurable Serum Concentration After the Second Infusion up to Week 12 (Clast)
|
5.95 µg/mL
Geometric Coefficient of Variation 154
|
8.52 µg/mL
Geometric Coefficient of Variation 145
|
6.76 µg/mL
Geometric Coefficient of Variation 143
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available T1/2 data.
Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=96 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=98 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=96 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Terminal Elimination Half-life (t1/2)
|
335.62 hours
Geometric Coefficient of Variation 38
|
375.26 hours
Geometric Coefficient of Variation 32
|
334.57 hours
Geometric Coefficient of Variation 40
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57 and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available λz data.
Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=101 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=103 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=98 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz)
|
0.00205 1/h
Geometric Coefficient of Variation 38.61018
|
0.00187 1/h
Geometric Coefficient of Variation 33.44044
|
0.00205 1/h
Geometric Coefficient of Variation 40.15779
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available CL data.
Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=94 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=96 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=94 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Clearance (CL)
|
0.01339 L/h
Geometric Coefficient of Variation 36.22558
|
0.01160 L/h
Geometric Coefficient of Variation 32.94524
|
0.01262 L/h
Geometric Coefficient of Variation 34.93316
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available MRT data.
Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=94 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=96 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=94 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Mean Residence Time (MRT)
|
549 hours
Geometric Coefficient of Variation 26.7
|
592 hours
Geometric Coefficient of Variation 26.5
|
557 hours
Geometric Coefficient of Variation 26.8
|
—
|
SECONDARY outcome
Timeframe: Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available AUC%extrap data.
Percent of AUC extrapolated to infinity in AUCinf. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=101 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=103 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=98 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Percent of AUC Extrapolation (AUC%Extrap)
|
1.91 percent extrapolation
Geometric Coefficient of Variation 161
|
2.62 percent extrapolation
Geometric Coefficient of Variation 146
|
2.06 percent extrapolation
Geometric Coefficient of Variation 148
|
—
|
SECONDARY outcome
Timeframe: Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose; day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).Population: The pharmacokinetic (PK) parameter analysis set (randomized participants who received the full protocol-specified infusion on day 1 and had an evaluable ABP 798 or rituximab serum concentration-time profile) with available data.
Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Outcome measures
| Measure |
ABP 798
n=96 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=98 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=96 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
AUC0-12 wk/AUCinf
|
0.97 ratio
Geometric Coefficient of Variation 3
|
0.96 ratio
Geometric Coefficient of Variation 4
|
0.97 ratio
Geometric Coefficient of Variation 3
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set with observed data conducted using a repeated measures analysis in which data from all assessed postbaseline time points were included.
The DAS28 measures the severity of disease at a specific time and is derived from the following variables: * 28 tender joint count * 28 swollen joint count * C-reactive protein (CRP) * Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Outcome measures
| Measure |
ABP 798
n=104 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=104 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=103 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
n=207 Participants
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28-CRP at Week 24
|
-2.006 units on a scale
Standard Error 0.1313
|
-2.116 units on a scale
Standard Error 0.1339
|
-1.936 units on a scale
Standard Error 0.1349
|
-2.026 units on a scale
Standard Error 0.1039
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 12, 40, and 48Population: Full analysis set with observed data
The DAS28 measures the severity of disease at a specific time and is derived from the following variables: * 28 tender joint count * 28 swollen joint count * C-reactive protein (CRP) * Patient's global health assessment measured on a 100 mm VAS, where 0 mm = no RA activity and 100 mm = worst RA activity imaginable. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.
Outcome measures
| Measure |
ABP 798
n=104 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=104 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=103 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Change From Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48
Week 8
|
-1.674 units on a scale
Standard Error 0.1259
|
-1.738 units on a scale
Standard Error 0.1335
|
-1.527 units on a scale
Standard Error 0.1330
|
—
|
|
Change From Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48
Week 12
|
-1.746 units on a scale
Standard Error 0.1302
|
-2.248 units on a scale
Standard Error 0.1357
|
-2.016 units on a scale
Standard Error 0.1367
|
—
|
|
Change From Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48
Week 40
|
-2.038 units on a scale
Standard Error 0.1440
|
-2.293 units on a scale
Standard Error 0.1494
|
-2.198 units on a scale
Standard Error 0.1489
|
—
|
|
Change From Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48
Week 48
|
-2.243 units on a scale
Standard Error 0.1473
|
-2.505 units on a scale
Standard Error 0.1553
|
-2.323 units on a scale
Standard Error 0.1486
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8, 12, 24, 40, and 48Population: Full analysis set with observed data
A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 20% improvement in 68 tender joint count; * ≥ 20% improvement in 66 swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global health assessment (measured on a 100 mm VAS); * Investigator's global health assessment (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein concentration.
Outcome measures
| Measure |
ABP 798
n=104 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=104 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=103 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR20 Response
Week 12
|
67.6 percentage of participants
|
73.3 percentage of participants
|
63.3 percentage of participants
|
—
|
|
Percentage of Participants With an ACR20 Response
Week 24
|
70.7 percentage of participants
|
66.7 percentage of participants
|
64.2 percentage of participants
|
—
|
|
Percentage of Participants With an ACR20 Response
Week 48
|
63.2 percentage of participants
|
79.8 percentage of participants
|
75.0 percentage of participants
|
—
|
|
Percentage of Participants With an ACR20 Response
Week 8
|
56.4 percentage of participants
|
60.0 percentage of participants
|
54.6 percentage of participants
|
—
|
|
Percentage of Participants With an ACR20 Response
Week 40
|
68.8 percentage of participants
|
73.7 percentage of participants
|
68.1 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8, 12, 24, 40, and 48Population: Full analysis set with observed data
A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 50% improvement in 68 tender joint count; * ≥ 50% improvement in 66 swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global health assessment (measured on a 100 mm VAS); * Investigator's global health assessment (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein concentration.
Outcome measures
| Measure |
ABP 798
n=104 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=104 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=103 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR50 Response
Week 24
|
39.8 percentage of participants
|
39.2 percentage of participants
|
38.5 percentage of participants
|
—
|
|
Percentage of Participants With an ACR50 Response
Week 8
|
26.7 percentage of participants
|
29.3 percentage of participants
|
24.7 percentage of participants
|
—
|
|
Percentage of Participants With an ACR50 Response
Week 12
|
36.3 percentage of participants
|
47.5 percentage of participants
|
32.7 percentage of participants
|
—
|
|
Percentage of Participants With an ACR50 Response
Week 40
|
48.9 percentage of participants
|
57.9 percentage of participants
|
45.7 percentage of participants
|
—
|
|
Percentage of Participants With an ACR50 Response
Week 48
|
51.2 percentage of participants
|
58.3 percentage of participants
|
48.9 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Weeks 8, 12, 24, 40, and 48Population: Full analysis set with observed data
A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: * ≥ 70% improvement in 68 tender joint count; * ≥ 70% improvement in 66 swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of disease-related pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global health assessment (measured on a 100 mm VAS); * Investigator's global health assessment (measured on a 100 mm VAS); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-reactive protein concentration.
Outcome measures
| Measure |
ABP 798
n=104 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=104 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=103 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Percentage of Participants With an ACR70 Response
Week 8
|
6.9 percentage of participants
|
12.0 percentage of participants
|
9.3 percentage of participants
|
—
|
|
Percentage of Participants With an ACR70 Response
Week 12
|
12.9 percentage of participants
|
19.8 percentage of participants
|
16.3 percentage of participants
|
—
|
|
Percentage of Participants With an ACR70 Response
Week 24
|
19.2 percentage of participants
|
19.6 percentage of participants
|
16.7 percentage of participants
|
—
|
|
Percentage of Participants With an ACR70 Response
Week 40
|
27.7 percentage of participants
|
27.7 percentage of participants
|
22.8 percentage of participants
|
—
|
|
Percentage of Participants With an ACR70 Response
Week 48
|
28.7 percentage of participants
|
39.3 percentage of participants
|
24.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and weeks 8, 12, 24, 40, and 48Population: Full analysis set with observed data
The hybrid ACR combines the ACR 20/50/70 response with the mean percent change in all 7 ACR core components, thus providing a percent improvement from baseline on a continuous scale. For each participant, the mean percent improvement from baseline across the 7 ACR core set measures (tender joint count, swollen joint count, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, disability index of the HAQ, and CRP) was calculated (a positive change indicates improvement, and the maximum worst change is limited to -100%) and the ACR20, ACR50, and ACR70 response is determined. The hybrid ACR is determined from a reference table taking into account both ACR response and mean percent improvement in the core set measures. Scores can range from -100% (maximal worsening) to 100% (maximal improvement).
Outcome measures
| Measure |
ABP 798
n=104 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=104 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=103 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Hybrid ACR
Week 8
|
32.631 percent improvement
Standard Error 2.7287
|
34.630 percent improvement
Standard Error 2.8058
|
32.086 percent improvement
Standard Error 2.8628
|
—
|
|
Hybrid ACR
Week 48
|
41.917 percent improvement
Standard Error 3.3878
|
48.546 percent improvement
Standard Error 3.4870
|
45.013 percent improvement
Standard Error 3.3942
|
—
|
|
Hybrid ACR
Week 12
|
36.604 percent improvement
Standard Error 2.8910
|
44.828 percent improvement
Standard Error 2.9412
|
38.664 percent improvement
Standard Error 3.0360
|
—
|
|
Hybrid ACR
Week 24
|
39.269 percent improvement
Standard Error 3.1660
|
40.589 percent improvement
Standard Error 3.1781
|
38.539 percent improvement
Standard Error 3.2436
|
—
|
|
Hybrid ACR
Week 40
|
41.042 percent improvement
Standard Error 3.1508
|
43.250 percent improvement
Standard Error 3.1916
|
41.078 percent improvement
Standard Error 3.2459
|
—
|
SECONDARY outcome
Timeframe: Day 3Population: Full analysis set participants with a day 3 CD19+ cell count; participants with missing CD19+ cell counts at baseline or with CD19+ cell count \< 20 cell/μL at baseline were excluded from the analysis.
Complete depletion of cluster of differentiation (CD) 19 positive cells was defined as a CD19+ cell count \< 20 cell/μL (0.02 x 10⁹ cell/L).
Outcome measures
| Measure |
ABP 798
n=97 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=96 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=97 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Depletion in CD19+ Cell Count on Day 3
|
94.8 percentage of participants
|
96.9 percentage of participants
|
92.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: CD19+ cell count was assessed at baseline, days 2, 3, weeks 4, 24, and 48Population: Full analysis set participants who had a CD19+ complete depletion for at least one postdose time point.
Duration of CD19+ B-cell complete depletion was defined as the time from the first incidence of complete depletion of CD19+ cell count (CD19+ cell count \< 20 cells/μL) to when the CD19+ cell count first increased to ≥ 20 cells/μL. Participants whose CD19+ cell count did not increase to ≥ 20 cells/μL were censored at the last CD19+ assessment date.
Outcome measures
| Measure |
ABP 798
n=95 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=99 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=98 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Duration of Complete Depletion in CD19+ Cell Count
|
NA days
Could not be estimated due to the low number of events
|
NA days
Interval 377.0 to
Could not be estimated due to the low number of events
|
NA days
Interval 338.0 to
Could not be estimated due to the low number of events
|
—
|
SECONDARY outcome
Timeframe: From day 1 until the first infusion of the second dose (week 24)Population: All randomized participants who received at least 1 infusion of study drug (safety analysis set)
Adverse events (AEs) were graded by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.03, where Grade 1 = mild AE, Grade 2 = moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE, and Grade 5 = death due to AE. A serious AE (SAE) was defined as an AE that met at least 1 of the following serious criteria: * fatal * life-threatening * required inpatient hospitalization or prolongation of existing hospitalization * resulted in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event. The adverse events of interest prespecified for this study included infusion reactions including hypersensitivity, cardiac disorders, serious infections, progressive multifocal leukoencephalopathy, hematological reactions, hepatitis B reactivation, opportunistic infections, hypogammaglobulinemia, severe mucocutaneous reactions, and gastrointestinal perforation.
Outcome measures
| Measure |
ABP 798
n=104 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=104 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=103 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events After the First Dose
Any adverse event
|
52 Participants
|
44 Participants
|
44 Participants
|
—
|
|
Number of Participants With Adverse Events After the First Dose
Any grade ≥ 3 adverse event
|
4 Participants
|
6 Participants
|
4 Participants
|
—
|
|
Number of Participants With Adverse Events After the First Dose
Any fatal adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Adverse Events After the First Dose
Any serious adverse event
|
4 Participants
|
5 Participants
|
5 Participants
|
—
|
|
Number of Participants With Adverse Events After the First Dose
Any AE leading to discontinuation of drug/study
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Adverse Events After the First Dose
Any AE leading to infusion delayed/ not given
|
6 Participants
|
6 Participants
|
7 Participants
|
—
|
|
Number of Participants With Adverse Events After the First Dose
Any adverse event of interest
|
19 Participants
|
11 Participants
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through the end of study (48 weeks).Population: Participants with a binding negative or no result at baseline and an available postbaseline result
Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect antibodies capable of binding to ABP 798/rituximab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a cell-based assay to determine neutralizing activity against ABP 798/rituximab (Neutralizing Antibody Assay). Developing antibody incidence was defined as participants with a negative or no binding antibody result at baseline and a positive antibody result at any post-baseline time point.
Outcome measures
| Measure |
ABP 798
n=97 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=94 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=97 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Number of Participants Who Developed Anti-drug Antibodies
Binding antibody positive
|
14 Participants
|
13 Participants
|
20 Participants
|
—
|
|
Number of Participants Who Developed Anti-drug Antibodies
Neutralizing antibody positive
|
8 Participants
|
4 Participants
|
10 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 through the end of study (48 weeks).Population: All randomized participants who received at least 1 infusion of study drug (safety analysis set)
Clinically significant clinical laboratory findings were defined as laboratory results that were ≥ Grade 3, based on the CTCAE version 4.03.
Outcome measures
| Measure |
ABP 798
n=104 Participants
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (EU)
n=104 Participants
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US)
n=103 Participants
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Rituximab (US + EU)
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Findings
Hemoglobin - decrease (anemia)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Findings
Lymphocytes - decrease
|
64 Participants
|
54 Participants
|
52 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Findings
Alanine aminotransferase - increase
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Findings
Gamma glutamyl transferase - increase
|
5 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Number of Participants With Clinically Significant Laboratory Findings
Potassium - increase (hyperkalemia)
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
Adverse Events
Weeks 1-24: ABP 798
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Weeks 1-24: Rituximab (EU)
Serious events: 5 serious events
Other events: 15 other events
Deaths: 0 deaths
Weeks 1-24: Rituximab (US)
Serious events: 5 serious events
Other events: 14 other events
Deaths: 0 deaths
Weeks 1-48: ABP 798 / ABP 798
Serious events: 8 serious events
Other events: 38 other events
Deaths: 0 deaths
Weeks 1-48: Rituximab (EU) / Rituximab (EU)
Serious events: 8 serious events
Other events: 22 other events
Deaths: 0 deaths
Weeks 1-48: Rituximab (US) / ABP 798
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Weeks 1-24: ABP 798
n=104 participants at risk
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Weeks 1-24: Rituximab (EU)
n=104 participants at risk
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Weeks 1-24: Rituximab (US)
n=103 participants at risk
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Weeks 1-48: ABP 798 / ABP 798
n=104 participants at risk
Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Weeks 1-48: Rituximab (EU) / Rituximab (EU)
n=104 participants at risk
Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Weeks 1-48: Rituximab (US) / ABP 798
n=103 participants at risk
Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Biliary tract infection
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papilloma of breast
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.96%
1/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Weeks 1-24: ABP 798
n=104 participants at risk
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
|
Weeks 1-24: Rituximab (EU)
n=104 participants at risk
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Weeks 1-24: Rituximab (US)
n=103 participants at risk
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
|
Weeks 1-48: ABP 798 / ABP 798
n=104 participants at risk
Participants received ABP 798 on days 1 and 15 (dose 1) and a second dose of ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Weeks 1-48: Rituximab (EU) / Rituximab (EU)
n=104 participants at risk
Participants received rituximab (EU formulation) on days 1 and 15 (dose 1) and a second dose of rituximab (EU formulation) at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
Weeks 1-48: Rituximab (US) / ABP 798
n=103 participants at risk
Participants received rituximab (US formulation) on days 1 and 15 (dose 1) and transitioned to receive ABP 798 at weeks 24 and 26 (dose 2). Each dose consisted of two 1000 mg intravenous infusions 2 weeks apart.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.8%
4/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
8/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
3/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
2.9%
3/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
7/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
3/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
5/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
4/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.97%
1/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
9/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.8%
6/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
4/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.8%
6/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
7/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.8%
8/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
13/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
9/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.7%
11/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
5.8%
6/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.9%
2/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
3/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.6%
10/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
3/104 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
4/103 • Dose 1: weeks 1 to 24. Doses 1 and 2: weeks 1 to 48.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER