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Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02792699
Recruitment Status : Completed
First Posted : June 7, 2016
Results First Posted : October 23, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Rheumatoid
Interventions Drug: ABP 798
Drug: Rituximab (US)
Drug: Rituximab (EU)
Enrollment 311
Recruitment Details

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.

Pre-assignment Details 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).
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description 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. 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. 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.
Period Title: Overall Study
Started 104 104 103
Received First Infusion of First Dose [1] 104 104 103
Received Second Infusion of First Dose [2] 102 103 99
Received First Infusion of Second Dose [3] 97 99 95
Received Second Infusion of Second Dose [4] 97 99 93
Completed 95 94 93
Not Completed 9 10 10
Reason Not Completed
Adverse Event             1             2             4
Withdrawal by Subject             4             4             3
Lost to Follow-up             0             1             2
Physician Decision             2             0             0
Dissatisfaction with Treatment Efficacy             1             3             1
Other             1             0             0
[1]
Day 1
[2]
Day 15 (week 2)
[3]
Week 24
[4]
Week 26
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798 Total
Hide Arm/Group Description 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 104 104 103 311
Hide Baseline Analysis Population Description
The full analysis set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 104 participants 103 participants 311 participants
54.6  (10.70) 56.8  (11.34) 56.4  (10.66) 55.9  (10.91)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 103 participants 311 participants
< 65 years
87
  83.7%
74
  71.2%
78
  75.7%
239
  76.8%
≥ 65 years
17
  16.3%
30
  28.8%
25
  24.3%
72
  23.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 103 participants 311 participants
Female
90
  86.5%
91
  87.5%
83
  80.6%
264
  84.9%
Male
14
  13.5%
13
  12.5%
20
  19.4%
47
  15.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 103 participants 311 participants
Hispanic or Latino
8
   7.7%
10
   9.6%
11
  10.7%
29
   9.3%
Not Hispanic or Latino
96
  92.3%
94
  90.4%
92
  89.3%
282
  90.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 103 participants 311 participants
White
97
  93.3%
99
  95.2%
91
  88.3%
287
  92.3%
Black or African American
5
   4.8%
3
   2.9%
10
   9.7%
18
   5.8%
Asian
0
   0.0%
2
   1.9%
1
   1.0%
3
   1.0%
American Indian or Alaska Native
2
   1.9%
0
   0.0%
0
   0.0%
2
   0.6%
Native Hawaiian or other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
0
   0.0%
0
   0.0%
1
   1.0%
1
   0.3%
Geographic Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 103 participants 311 participants
North America
38
  36.5%
40
  38.5%
39
  37.9%
117
  37.6%
Eastern Europe
59
  56.7%
58
  55.8%
59
  57.3%
176
  56.6%
Western Europe
7
   6.7%
6
   5.8%
5
   4.9%
18
   5.8%
Duration of RA  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 104 participants 103 participants 311 participants
11.37  (7.400) 11.69  (7.945) 12.48  (9.186) 11.84  (8.194)
Disease Activity Score 28 – C-Reactive Protein (DAS28[CRP])   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 103 participants 102 participants 103 participants 308 participants
6.09  (1.035) 5.84  (1.006) 6.03  (0.997) 5.99  (1.015)
[1]
Measure Description:

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 visual analog scale. 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.
[2]
Measure Analysis Population Description: Full analysis set with available data
Seropositivity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 103 participants 311 participants
RF positive and/or CCP positive
86
  82.7%
88
  84.6%
89
  86.4%
263
  84.6%
RF negative and CCP negative
18
  17.3%
16
  15.4%
14
  13.6%
48
  15.4%
[1]
Measure Description: Seropositivity defined as rheumatoid factor [RF]-positive and/or cyclic citrullinated peptide [CCP]-positive vs RF-negative and CCP-negative).
Prior Biologic Use for RA  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 104 participants 103 participants 311 participants
One
62
  59.6%
61
  58.7%
63
  61.2%
186
  59.8%
More than one
42
  40.4%
43
  41.3%
40
  38.8%
125
  40.2%
1.Primary Outcome
Title Area Under the Serum Concentration-time Curve From Time 0 to Infinity (AUCinf) After the Second Infusion of the First Dose
Hide Description 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.
Time Frame Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 94 96 94
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
149398
(36.2%)
172463
(32.9%)
158529
(34.9%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric LS Mean
Estimated Value 152371.4
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rituximab (US)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 159236.0
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rituximab (EU)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 172213.2
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9569
Confidence Interval (2-Sided) 90%
0.8870 to 1.0323
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (EU)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.8848
Confidence Interval (2-Sided) 90%
0.8204 to 0.9542
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Rituximab (EU), Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUCinf was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9246
Confidence Interval (2-Sided) 90%
0.8575 to 0.9970
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Observed Drug Concentration (Cmax) After the Second Infusion of the First Dose
Hide Description 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.
Time Frame Day 15, pre-dose, end of infusion, and 3, 6, 24, and 48 hours, and 2, 6, and 10 weeks postdose.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 96 97 93
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
361
(23.5%)
394
(22.0%)
372
(24.7%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric LS Mean
Estimated Value 368.43
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rituximab (US)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 374.44
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rituximab (EU)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 393.29
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [US]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9840
Confidence Interval (2-Sided) 90%
0.9356 to 1.0348
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (EU)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9368
Confidence Interval (2-Sided) 90%
0.8912 to 0.9848
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Rituximab (EU), Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9521
Confidence Interval (2-Sided) 90%
0.9055 to 1.0010
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Area Under the Serum Concentration-time Curve From Predose on Day 1 to 14 Days Postdose (AUC0-14day)
Hide Description 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.
Time Frame Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 98 97 93
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
41445
(28.8%)
45161
(24.7%)
43291
(29.6%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric LS Mean
Estimated Value 42203.8
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rituximab (US)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 43378.8
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rituximab (EU)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 44925.3
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9729
Confidence Interval (2-Sided) 90%
0.9174 to 1.0318
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (EU)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9394
Confidence Interval (2-Sided) 90%
0.8863 to 0.9958
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Rituximab (EU), Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUC0-14day was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9656
Confidence Interval (2-Sided) 90%
0.9104 to 1.0240
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Area Under the Serum Concentration-time Curve From Predose on Day 1 to Week 12 (AUC0-12wk)
Hide Description 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.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 99 100 96
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*µg/mL
146369
(34.3%)
166995
(30.5%)
155240
(33.7%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric LS Mean
Estimated Value 149590.5
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rituximab (US)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 155778.7
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rituximab (EU)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 166811.0
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance (ANCOVA) model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [US]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9603
Confidence Interval (2-Sided) 90%
0.8950 to 1.0303
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (EU)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an analysis of covariance ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [EU]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.8968
Confidence Interval (2-Sided) 90%
0.8363 to 0.9616
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Rituximab (EU), Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for AUC0-12wk was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9339
Confidence Interval (2-Sided) 90%
0.8707 to 1.0016
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Maximum Observed Drug Concentration (Cmax) After the First Infusion of the First Dose
Hide Description Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame Day 1, predose, at end of infusion, 3, 6, 24, and 48 hours postdose and day 15, predose.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 103 103 99
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
298
(26.1%)
321
(21.2%)
304
(25.5%)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric LS Mean
Estimated Value 304.04
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rituximab (US)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 305.80
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Rituximab (EU)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Geometric Mean
Estimated Value 320.87
Estimation Comments Estimated using an analysis of covariance model adjusted for weight and geographic region.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [US]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9942
Confidence Interval (2-Sided) 90%
0.9461 to 1.0448
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (EU)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (ABP 798) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9475
Confidence Interval (2-Sided) 90%
0.9021 to 0.9953
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Rituximab (EU), Rituximab (US)
Comments The geometric mean ratio (GMR) and confidence interval (CI) was estimated from an ANCOVA model adjusted for weight and geographic region. The GMR was obtained by exponentiating the difference of the means on the natural log scale. The CI was obtained by exponentiating the CI for the difference between the means on the log scale.
Type of Statistical Test Equivalence
Comments PK similarity between the test (rituximab [US]) and reference (rituximab [EU]) for Cmax was demonstrated if the 90% CI for the GMR following the second infusion of the first dose was within the bioequivalence criteria of 0.8 to 1.25.
Method of Estimation Estimation Parameter Geometric Mean Ratio
Estimated Value 0.9531
Confidence Interval (2-Sided) 90%
0.9070 to 1.0015
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Time of Maximum Observed Drug Concentration (Tmax) After the First and Second Infusions of the First Dose
Hide Description Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 103 103 99
Median (Inter-Quartile Range)
Unit of Measure: hours
After First Infusion (Day 1) Number Analyzed 103 participants 103 participants 99 participants
4.50
(4.35 to 7.18)
4.67
(4.38 to 7.30)
4.68
(4.38 to 7.50)
After Second Infusion (Day 15) Number Analyzed 96 participants 97 participants 93 participants
3.57
(3.42 to 6.03)
3.67
(3.40 to 5.50)
4.12
(3.42 to 6.55)
7.Secondary Outcome
Title Last Measurable Serum Concentration After the Second Infusion up to Week 12 (Clast)
Hide Description Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 101 103 98
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
5.95
(154%)
8.52
(145%)
6.76
(143%)
8.Secondary Outcome
Title Terminal Elimination Half-life (t1/2)
Hide Description Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 96 98 96
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
335.62
(38%)
375.26
(32%)
334.57
(40%)
9.Secondary Outcome
Title Terminal Elimination Rate Constant (λz)
Hide Description Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 101 103 98
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: 1/h
0.00205
(38.61018%)
0.00187
(33.44044%)
0.00205
(40.15779%)
10.Secondary Outcome
Title Clearance (CL)
Hide Description Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 94 96 94
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: L/h
0.01339
(36.22558%)
0.01160
(32.94524%)
0.01262
(34.93316%)
11.Secondary Outcome
Title Mean Residence Time (MRT)
Hide Description Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 94 96 94
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
549
(26.7%)
592
(26.5%)
557
(26.8%)
12.Secondary Outcome
Title Percent of AUC Extrapolation (AUC%Extrap)
Hide Description Percent of AUC extrapolated to infinity in AUCinf. Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame Day 15, predose, end of infusion, 3, 6, 24, and 48 hours postdose, and at days 29, 57, and 85 (week 12).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 101 103 98
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: percent extrapolation
1.91
(161%)
2.62
(146%)
2.06
(148%)
13.Secondary Outcome
Title AUC0-12 wk/AUCinf
Hide Description Concentrations of ABP-798 and rituximab were quantified using a validated electrochemiluminescent method.
Time Frame 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).
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 96 98 96
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ratio
0.97
(3%)
0.96
(4%)
0.97
(3%)
14.Secondary Outcome
Title Change From Baseline in Disease Activity Score 28-CRP at Week 24
Hide Description

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.

Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with observed data conducted using a repeated measures analysis in which data from all assessed postbaseline time points were included.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US) Rituximab (US + EU)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US or EU formulation) on days 1 and 15 (dose 1) by intravenous infusion.
Overall Number of Participants Analyzed 104 104 103 207
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.006  (0.1313) -2.116  (0.1339) -1.936  (0.1349) -2.026  (0.1039)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (US + EU)
Comments If PK similarity was established between rituximab (US) and rituximab (EU), the 2 rituximab arms were to be combined into a single reference group for the primary assessment of clinical equivalence of DAS28-CRP change from baseline at week 24 using a repeated measures analysis with DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and baseline DAS28-CRP as predictors, and unstructured covariance matrix in the model.
Type of Statistical Test Equivalence
Comments Clinical equivalence was tested by comparing the 2-sided 90% CI of the change from baseline at week 24 of DAS28-CRP between ABP 798 and rituximab with an equivalence margin of (-0.6, 0.6).
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.020
Confidence Interval (2-Sided) 90%
-0.225 to 0.264
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (US)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.070
Confidence Interval (2-Sided) 90%
-0.353 to 0.213
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (EU)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.110
Confidence Interval (2-Sided) 90%
-0.171 to 0.392
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline in Disease Activity Score 28-CRP at Weeks 8, 12, 40, and 48
Hide Description

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.

Time Frame Baseline and weeks 8, 12, 40, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with observed data
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 104 104 103
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 8 Number Analyzed 98 participants 94 participants 96 participants
-1.674  (0.1259) -1.738  (0.1335) -1.527  (0.1330)
Week 12 Number Analyzed 95 participants 98 participants 95 participants
-1.746  (0.1302) -2.248  (0.1357) -2.016  (0.1367)
Week 40 Number Analyzed 93 participants 93 participants 92 participants
-2.038  (0.1440) -2.293  (0.1494) -2.198  (0.1489)
Week 48 Number Analyzed 86 participants 83 participants 89 participants
-2.243  (0.1473) -2.505  (0.1553) -2.323  (0.1486)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.064
Confidence Interval (2-Sided) 90%
-0.203 to 0.330
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of change from baseline at week 8, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.147
Confidence Interval (2-Sided) 90%
-0.411 to 0.117
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.502
Confidence Interval (2-Sided) 90%
0.233 to 0.772
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of change from baseline at week 12, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.270
Confidence Interval (2-Sided) 90%
0.000 to 0.539
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.255
Confidence Interval (2-Sided) 90%
-0.040 to 0.550
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of change from baseline at week 40, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.160
Confidence Interval (2-Sided) 90%
-0.135 to 0.455
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.262
Confidence Interval (2-Sided) 90%
-0.040 to 0.564
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of change from baseline at week 48, based on an ANCOVA model adjusted for baseline DAS28-CRP and the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.080
Confidence Interval (2-Sided) 90%
-0.216 to 0.376
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants With an ACR20 Response
Hide Description

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.
Time Frame Baseline and Weeks 8, 12, 24, 40, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with observed data
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 104 104 103
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 Number Analyzed 101 participants 100 participants 97 participants
56.4 60.0 54.6
Week 12 Number Analyzed 102 participants 101 participants 98 participants
67.6 73.3 63.3
Week 24 Number Analyzed 99 participants 102 participants 95 participants
70.7 66.7 64.2
Week 40 Number Analyzed 93 participants 95 participants 91 participants
68.8 73.7 68.1
Week 48 Number Analyzed 87 participants 84 participants 88 participants
63.2 79.8 75.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.9339
Confidence Interval (2-Sided) 90%
0.7696 to 1.1332
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0360
Confidence Interval (2-Sided) 90%
-0.1495 to 0.0775
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0392
Confidence Interval (2-Sided) 90%
0.8436 to 1.2801
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0246
Confidence Interval (2-Sided) 90%
-0.0910 to 0.1402
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.8780
Confidence Interval (2-Sided) 90%
0.7573 to 1.0179
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0794
Confidence Interval (2-Sided) 90%
-0.1834 to 0.0247
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0426
Confidence Interval (2-Sided) 90%
0.8770 to 1.2394
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0348
Confidence Interval (2-Sided) 90%
-0.0758 to 0.1454
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0102
Confidence Interval (2-Sided) 90%
0.8743 to 1.1671
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0199
Confidence Interval (2-Sided) 90%
-0.0835 to 0.1234
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0793
Confidence Interval (2-Sided) 90%
0.9244 to 1.2601
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0561
Confidence Interval (2-Sided) 90%
-0.0493 to 0.1615
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.8848
Confidence Interval (2-Sided) 90%
0.7759 to 1.0091
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0776
Confidence Interval (2-Sided) 90%
-0.1789 to 0.0237
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.9982
Confidence Interval (2-Sided) 90%
0.8585 to 1.1605
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0008
Confidence Interval (2-Sided) 90%
-0.1038 to 0.1054
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.7862
Confidence Interval (2-Sided) 90%
0.6722 to 0.9196
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.2004
Confidence Interval (2-Sided) 90%
-0.3066 to -0.0941
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.8804
Confidence Interval (2-Sided) 90%
0.7587 to 1.0215
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.1037
Confidence Interval (2-Sided) 90%
-0.2066 to -0.0007
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With an ACR50 Response
Hide Description

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.
Time Frame Baseline and Weeks 8, 12, 24, 40, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with observed data
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 104 104 103
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 Number Analyzed 101 participants 99 participants 97 participants
26.7 29.3 24.7
Week 12 Number Analyzed 102 participants 101 participants 98 participants
36.3 47.5 32.7
Week 24 Number Analyzed 98 participants 102 participants 96 participants
39.8 39.2 38.5
Week 40 Number Analyzed 94 participants 95 participants 92 participants
48.9 57.9 45.7
Week 48 Number Analyzed 86 participants 84 participants 88 participants
51.2 58.3 48.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.9256
Confidence Interval (2-Sided) 90%
0.6400 to 1.3388
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0181
Confidence Interval (2-Sided) 90%
-0.1209 to 0.0847
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0868
Confidence Interval (2-Sided) 90%
0.7328 to 1.6119
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0201
Confidence Interval (2-Sided) 90%
-0.0803 to 0.1205
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.7095
Confidence Interval (2-Sided) 90%
0.5387 to 0.9346
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.1109
Confidence Interval (2-Sided) 90%
-0.2231 to 0.0013
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0882
Confidence Interval (2-Sided) 90%
0.7829 to 1.5127
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0441
Confidence Interval (2-Sided) 90%
-0.0626 to 0.1508
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.9612
Confidence Interval (2-Sided) 90%
0.7273 to 1.2705
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0020
Confidence Interval (2-Sided) 90%
-0.1081 to 0.1122
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0029
Confidence Interval (2-Sided) 90%
0.7560 to 1.3305
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0039
Confidence Interval (2-Sided) 90%
-0.1056 to 0.1135
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.8373
Confidence Interval (2-Sided) 90%
0.6797 to 1.0316
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0863
Confidence Interval (2-Sided) 90%
-0.2029 to 0.0302
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1191
Confidence Interval (2-Sided) 90%
0.8780 to 1.4264
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0288
Confidence Interval (2-Sided) 90%
-0.0827 to 0.1402
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.8376
Confidence Interval (2-Sided) 90%
0.6807 to 1.0307
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0781
Confidence Interval (2-Sided) 90%
-0.2014 to 0.0452
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0548
Confidence Interval (2-Sided) 90%
0.8351 to 1.3321
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0141
Confidence Interval (2-Sided) 90%
-0.1021 to 0.1303
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With an ACR70 Response
Hide Description

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.
Time Frame Baseline and Weeks 8, 12, 24, 40, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with observed data
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 104 104 103
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 Number Analyzed 101 participants 100 participants 97 participants
6.9 12.0 9.3
Week 12 Number Analyzed 101 participants 101 participants 98 participants
12.9 19.8 16.3
Week 24 Number Analyzed 99 participants 102 participants 96 participants
19.2 19.6 16.7
Week 40 Number Analyzed 94 participants 94 participants 92 participants
27.7 27.7 22.8
Week 48 Number Analyzed 87 participants 84 participants 89 participants
28.7 39.3 24.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.5926
Confidence Interval (2-Sided) 90%
0.2818 to 1.2462
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0574
Confidence Interval (2-Sided) 90%
-0.1285 to 0.0136
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.7476
Confidence Interval (2-Sided) 90%
0.3383 to 1.6519
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0327
Confidence Interval (2-Sided) 90%
-0.0962 to 0.0308
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.6346
Confidence Interval (2-Sided) 90%
0.3704 to 1.0872
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0569
Confidence Interval (2-Sided) 90%
-0.1448 to 0.0310
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.7857
Confidence Interval (2-Sided) 90%
0.4450 to 1.3874
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0417
Confidence Interval (2-Sided) 90%
-1237 to 0.0403
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.9254
Confidence Interval (2-Sided) 90%
0.5772 to 1.4838
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0156
Confidence Interval (2-Sided) 90%
-0.0780 to 0.1092
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1120
Confidence Interval (2-Sided) 90%
0.6722 to 1.8398
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0244
Confidence Interval (2-Sided) 90%
-0.0630 to 0.1119
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.9798
Confidence Interval (2-Sided) 90%
0.6675 to 1.4384
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0375
Confidence Interval (2-Sided) 90%
-0.0707 to 0.1456
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1831
Confidence Interval (2-Sided) 90%
0.7833 to 1.7870
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0752
Confidence Interval (2-Sided) 90%
-0.0297 to 0.1802
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.7027
Confidence Interval (2-Sided) 90%
0.4930 to 1.0017
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Risk difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0908
Confidence Interval (2-Sided) 90%
-0.2110 to 0.0294
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk ratio (ABP 798/ABP 798 versus Rituximab [US]/ABP 798]) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.1449
Confidence Interval (2-Sided) 90%
0.7601 to 1.7246
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Risk difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on a generalized linear model adjusted for the stratification factors geographic region, seropositivity, and number of prior biologic therapies used for RA as covariates.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0277
Confidence Interval (2-Sided) 90%
-0.0804 to 0.1357
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Hybrid ACR
Hide Description 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).
Time Frame Baseline and weeks 8, 12, 24, 40, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set with observed data
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 104 104 103
Least Squares Mean (Standard Error)
Unit of Measure: percent improvement
Week 8 Number Analyzed 94 participants 95 participants 92 participants
32.631  (2.7287) 34.630  (2.8058) 32.086  (2.8628)
Week 12 Number Analyzed 98 participants 101 participants 94 participants
36.604  (2.8910) 44.828  (2.9412) 38.664  (3.0360)
Week 24 Number Analyzed 94 participants 100 participants 93 participants
39.269  (3.1660) 40.589  (3.1781) 38.539  (3.2436)
Week 40 Number Analyzed 91 participants 94 participants 89 participants
41.042  (3.1508) 43.250  (3.1916) 41.078  (3.2459)
Week 48 Number Analyzed 85 participants 84 participants 87 participants
41.917  (3.3878) 48.546  (3.4870) 45.013  (3.3942)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.999
Confidence Interval (2-Sided) 90%
-7.673 to 3.675
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 8, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.544
Confidence Interval (2-Sided) 90%
-5.185 to 6.274
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -8.224
Confidence Interval (2-Sided) 90%
-14.102 to -2.346
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 12, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.060
Confidence Interval (2-Sided) 90%
-8.052 to 3.933
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.320
Confidence Interval (2-Sided) 90%
-7.620 to 4.979
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 24, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 0.730
Confidence Interval (2-Sided) 90%
-5.691 to 7.150
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -2.207
Confidence Interval (2-Sided) 90%
-8.562 to 1.417
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 40, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -0.036
Confidence Interval (2-Sided) 90%
-6.497 to 6.424
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (EU) / Rituximab (EU)
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [EU]/Rituximab [EU]) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.629
Confidence Interval (2-Sided) 90%
-13.455 to 0.197
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection ABP 798 / ABP 798, Rituximab (US) / ABP 798
Comments Analysis of the LS mean difference (ABP 798/ABP 798 - Rituximab [US]/ABP 798) at week 48, based on an ANCOVA model adjusted for the stratification variables geographic region, seropositivity, and number of prior biologic therapies used for RA.
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.096
Confidence Interval (2-Sided) 90%
-9.883 to 3.691
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants With Complete Depletion in CD19+ Cell Count on Day 3
Hide Description 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).
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 97 96 97
Measure Type: Number
Unit of Measure: percentage of participants
94.8 96.9 92.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (EU)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0245
Confidence Interval (2-Sided) 90%
-0.1083 to 0.0593
Estimation Comments Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ABP 798, Rituximab (US)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0187
Confidence Interval (2-Sided) 90%
-0.0610 to 0.0984
Estimation Comments Based on a generalized linear model adjusted for geographic region, seropositivity and prior biologic use as covariates in the model.
21.Secondary Outcome
Title Duration of Complete Depletion in CD19+ Cell Count
Hide Description 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.
Time Frame CD19+ cell count was assessed at baseline, days 2, 3, weeks 4, 24, and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set participants who had a CD19+ complete depletion for at least one postdose time point.
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 95 99 98
Median (90% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(377.0 to NA)
NA [1] 
(338.0 to NA)
[1]
Could not be estimated due to the low number of events
22.Secondary Outcome
Title Number of Participants With Adverse Events After the First Dose
Hide Description

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.
Time Frame From day 1 until the first infusion of the second dose (week 24)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 infusion of study drug (safety analysis set)
Arm/Group Title ABP 798 Rituximab (EU) Rituximab (US)
Hide Arm/Group Description:
Participants received 1000 mg ABP 798 by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (EU formulation) by intravenous infusion on days 1 and 15 (dose 1).
Participants received 1000 mg rituximab (US formulation) by intravenous infusion on days 1 and 15 (dose 1).
Overall Number of Participants Analyzed 104 104 103
Measure Type: Count of Participants
Unit of Measure: Participants
Any adverse event
52
  50.0%
44
  42.3%
44
  42.7%
Any grade ≥ 3 adverse event
4
   3.8%
6
   5.8%
4
   3.9%
Any fatal adverse event
0
   0.0%
0
   0.0%
0
   0.0%
Any serious adverse event
4
   3.8%
5
   4.8%
5
   4.9%
Any AE leading to discontinuation of drug/study
3
   2.9%
1
   1.0%
4
   3.9%
Any AE leading to infusion delayed/ not given
6
   5.8%
6
   5.8%
7
   6.8%
Any adverse event of interest
19
  18.3%
11
  10.6%
18
  17.5%
23.Secondary Outcome
Title Number of Participants Who Developed Anti-drug Antibodies
Hide Description

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.

Time Frame Day 1 through the end of study (48 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with a binding negative or no result at baseline and an available postbaseline result
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 97 94 97
Measure Type: Count of Participants
Unit of Measure: Participants
Binding antibody positive
14
  14.4%
13
  13.8%
20
  20.6%
Neutralizing antibody positive
8
   8.2%
4
   4.3%
10
  10.3%
24.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Findings
Hide Description Clinically significant clinical laboratory findings were defined as laboratory results that were ≥ Grade 3, based on the CTCAE version 4.03.
Time Frame Day 1 through the end of study (48 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 infusion of study drug (safety analysis set)
Arm/Group Title ABP 798 / ABP 798 Rituximab (EU) / Rituximab (EU) Rituximab (US) / ABP 798
Hide Arm/Group Description:
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.
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.