Arthritis, Rheumatoid
Conditions
Brief summary
The main purpose of the study was to compare rheumatoid arthritis symptom improvement in participants who were given ABP 710 to those who were given infliximab, 22 weeks after starting treatment.
Interventions
BIOLOGICALABP 710
Administered by intravenous infusion
BIOLOGICALInfliximab
Administered by intravenous infusion
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subject (man or woman) is ≥ 18 and ≤ 80 years old. * Subject is diagnosed with rheumatoid arthritis (RA) as determined by meeting the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism classification criteria for RA. * Subject has RA duration of at least 3 months. * Subject has active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints (based on 66/68 joint count excluding distal interphalangeal joints) at screening and baseline and at least 1 of the following at screening: * erythrocyte sedimentation rate ≥ 28 mm/hr * serum C-reactive protein \> 1.0 mg/dL * Subject has a positive rheumatoid factor or anti-cyclic citrullinated peptide at screening. * Subject has taken methotrexate (MTX) for ≥ 12 consecutive weeks and is on a stable dose of oral or subcutaneous MTX 7.5 to 25 mg/week for ≥ 8 weeks before receiving the investigational product and is willing to remain on a stable dose throughout the study. * For a subject on nonsteroidal anti-inflammatory drugs (NSAIDs) or low potency analgesics such as tramadol, Soma Compounds, Fioricet, or Fiorinal, the dose should be stable for ≥ 2 weeks before screening. * For a subject on oral corticosteroids (≤ 10 mg prednisone or equivalent), the dose should be stable for ≥ 4 weeks before screening. * Subject has no known history of active tuberculosis. * Subject has a negative test for tuberculosis during screening defined as either: * negative purified protein derivative (PPD) defined as \< 5 mm of induration at 48 to 72 hours after test is placed OR * negative Quantiferon test * Subject with a positive PPD and a history of Bacillus Calmette-Guérin vaccination is allowed with a negative Quantiferon test. * Subject with a positive PPD test (without a history of Bacillus Calmette-Guérin vaccination) or a subject with a positive or indeterminate Quantiferon test is allowed if they have all of the following: * no symptoms of tuberculosis according to the worksheet provided by the sponsor, Amgen Inc. * documented history of adequate prophylaxis initiation before receiving investigational product in accordance with local recommendations * no known exposure to a case of active tuberculosis after most recent prophylaxis
Exclusion criteria
* Subject has a history of prosthetic or native joint infection. * Subject has an active infection or history of infections as follows: * any active infection for which systemic anti-infectives were used within 28 days before first dose of investigational product * a serious infection, defined as requiring hospitalization or intravenous (IV) anti-infective(s) within 8 weeks before the first dose of investigational product * recurrent or chronic infections or other active infection that, in the opinion of the investigator, might cause this study to be detrimental to the subject * Subject has a positive blood test for human immunodeficiency virus (HIV). * Subject has a positive hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody result at screening. * Subject has uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate or severe heart failure (New York Heart Association Class III/IV), renal disease, liver disease, or hypertension. * Subject had a malignancy within 5 years EXCEPT for treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma. * Subject has a history of neurologic symptoms suggestive of central or peripheral nervous system demyelinating disease. * Subject has a major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome. * Subject has a concurrent medical condition that, in the opinion of the investigator, could cause this study to be detrimental to the subject. * Subject has laboratory abnormalities at screening, including any of the following: * hemoglobin \< 9 g/dL * platelet count \< 100 000/mm³ * white blood cell count \< 3 000/mm³ * aspartate aminotransferase and/or alanine aminotransferase ≥ 2.0 x the upper limit of normal * creatinine clearance \< 50 mL/min (Cockroft-Gault formula) * any other laboratory abnormality, that, in the opinion of the investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results. * Subject has used commercially available or investigational biologic therapies for RA as follows: * anakinra, etanercept within 1 month before the first dose of investigational product * abatacept, tocilizumab, adalimumab, golimumab, certolizumab within 3 months before the first dose of investigational product * other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) before the first dose of investigational product * rituximab within 9 months before the investigational product along with evidence of incomplete B cell recovery * Subject has received live vaccines within 28 days before the first dose of investigational product or plans to receive live vaccines during the course of the study. * Subject has previously received Remicade® (infliximab) or a biosimilar of infliximab. * Woman who is pregnant or breast feeding, or plans to become pregnant while enrolled in the study and for 6 months after the last dose of investigational product. * Women of childbearing potential (ie, neither surgically sterile nor postmenopausal) and do not agree to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera® \[medroxyprogesterone\] injections, or contraceptive implants) while on study and for 6 months after the last dose of investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22 | Baseline and week 22 | The primary efficacy endpoint was the response difference (RD) of 20% improvement in ACR core set measurements (ACR20) at week 22. 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an ACR20 Response After Week 22 | Baseline and weeks 30, 34, 38, 46, and 50 | 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. |
| Percentage of Participants With an ACR50 Response Through Week 22 | Baseline and weeks 2, 6, 14, and 22 | 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. |
| Percentage of Participants With an ACR50 Response After Week 22 | Baseline and weeks 30, 34, 38, 46, and 50 | 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. |
| Percentage of Participants With an ACR20 Response Through Week 14 | Baseline and weeks 2, 6, and 14 | 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. |
| Percentage of Participants With an ACR70 Response After Week 22 | Baseline and weeks 30, 34, 38, 46, and 50 | 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. |
| Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Baseline and weeks 2, 6, 14, and 22 | 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. |
| Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Baseline and weeks 30, 34, 38, 46, and 50 | 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. |
| Percentage of Participants With an ACR70 Response Through Week 22 | Baseline and weeks 2, 6, 14, and 22 | 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. |
Countries
Australia, Bulgaria, Canada, Czechia, Germany, Hungary, Poland, Spain, United States
Participant flow
Recruitment details
This study was conducted at 75 centers in Australia, Bulgaria, Canada, Czech Republic, Germany, Hungary, Poland, Spain, and the United States.
Pre-assignment details
Participants were randomized in a 1:1 ratio to receive ABP 710 or infliximab, stratified by geographic region and prior biologic use. At week 22 participants initially randomized to infliximab were re-randomized in a 1:1 ratio to continue infliximab or switch to ABP 710. Participants initially randomized to ABP 710 continued receiving ABP 710.
Participants by arm
| Arm | Count |
|---|---|
| ABP 710 Participants randomized to receive a 3 mg/kg intravenous (IV) infusion of ABP 710 on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22. | 279 |
| Infliximab Participants randomized to receive 3 mg/kg IV infusion of infliximab on day 1, at weeks 2 and 6, and every 8 weeks thereafter until week 22. | 279 |
| Total | 558 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Day 1 to Week 22 | Adverse Event | 11 | 14 | 0 | 0 | 0 |
| Day 1 to Week 22 | Death | 1 | 1 | 0 | 0 | 0 |
| Day 1 to Week 22 | Dissatisfied With Treatment Efficacy | 5 | 9 | 0 | 0 | 0 |
| Day 1 to Week 22 | Lost to Follow-up | 1 | 1 | 0 | 0 | 0 |
| Day 1 to Week 22 | Other | 1 | 0 | 0 | 0 | 0 |
| Day 1 to Week 22 | Physician Decision | 2 | 0 | 0 | 0 | 0 |
| Day 1 to Week 22 | Protocol Specified Criteria | 7 | 7 | 0 | 0 | 0 |
| Day 1 to Week 22 | Protocol Violation | 1 | 1 | 0 | 0 | 0 |
| Day 1 to Week 22 | Withdrawal by Subject | 6 | 6 | 0 | 0 | 0 |
| Week 22 to Week 50 | Adverse Event | 0 | 0 | 10 | 3 | 3 |
| Week 22 to Week 50 | Dissatisfied with Treatment Efficacy | 0 | 0 | 10 | 3 | 2 |
| Week 22 to Week 50 | Lost to Follow-up | 0 | 0 | 2 | 0 | 1 |
| Week 22 to Week 50 | Other | 0 | 0 | 0 | 0 | 1 |
| Week 22 to Week 50 | Physician Decision | 0 | 0 | 2 | 0 | 1 |
| Week 22 to Week 50 | Withdrawal by Subject | 0 | 0 | 8 | 2 | 1 |
Baseline characteristics
| Characteristic | ABP 710 | Infliximab | Total |
|---|---|---|---|
| Age, Continuous | 55.0 years STANDARD_DEVIATION 11.72 | 54.8 years STANDARD_DEVIATION 11.42 | 54.9 years STANDARD_DEVIATION 11.56 |
| Age, Customized < 65 years | 217 Participants | 217 Participants | 434 Participants |
| Age, Customized ≥ 65 years | 62 Participants | 62 Participants | 124 Participants |
| C-reactive Protein (CRP) Concentration | 14.26 mg/L STANDARD_DEVIATION 20.171 | 14.64 mg/L STANDARD_DEVIATION 23.117 | 14.45 mg/L STANDARD_DEVIATION 21.675 |
| Disability Index of the Health Assessment Questionnaire (HAQ-DI) | 1.44 units on a scale STANDARD_DEVIATION 0.584 | 1.42 units on a scale STANDARD_DEVIATION 0.617 | 1.43 units on a scale STANDARD_DEVIATION 0.601 |
| Duration of Rheumatoid Arthritis (RA) | 8.72 years STANDARD_DEVIATION 7.914 | 8.34 years STANDARD_DEVIATION 7.604 | 8.53 years STANDARD_DEVIATION 7.756 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 13 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 261 Participants | 266 Participants | 527 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Geographic Region Asia Pacific | 5 Participants | 4 Participants | 9 Participants |
| Geographic Region Europe | 220 Participants | 222 Participants | 442 Participants |
| Geographic Region North America | 54 Participants | 53 Participants | 107 Participants |
| Investigator's Global Health Assessment | 64.5 mm STANDARD_DEVIATION 15.88 | 64.1 mm STANDARD_DEVIATION 15.76 | 64.3 mm STANDARD_DEVIATION 15.81 |
| Patient Global Health Assessment | 65.4 mm STANDARD_DEVIATION 18.13 | 64.1 mm STANDARD_DEVIATION 20.03 | 64.7 mm STANDARD_DEVIATION 19.1 |
| Patient's Assessment of Disease-related Pain | 63.5 mm STANDARD_DEVIATION 20.3 | 61.5 mm STANDARD_DEVIATION 21.65 | 62.5 mm STANDARD_DEVIATION 20.99 |
| Prior Biologic Use for Rheumatoid Arthritis No | 202 Participants | 198 Participants | 400 Participants |
| Prior Biologic Use for Rheumatoid Arthritis Yes | 77 Participants | 81 Participants | 158 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 12 Participants | 12 Participants | 24 Participants |
| Race/Ethnicity, Customized White | 265 Participants | 267 Participants | 532 Participants |
| Sex: Female, Male Female | 214 Participants | 223 Participants | 437 Participants |
| Sex: Female, Male Male | 65 Participants | 56 Participants | 121 Participants |
| Swollen joint Count | 14.595 joints STANDARD_DEVIATION 8.0507 | 14.730 joints STANDARD_DEVIATION 8.8315 | 14.663 joints STANDARD_DEVIATION 8.4428 |
| Tender Joint Count | 23.109 joints STANDARD_DEVIATION 12.1648 | 23.764 joints STANDARD_DEVIATION 13.38 | 23.436 joints STANDARD_DEVIATION 12.7796 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 278 | 1 / 278 | 0 / 241 | 0 / 121 | 0 / 119 |
| other Total, other adverse events | 48 / 278 | 32 / 278 | 52 / 241 | 28 / 121 | 30 / 119 |
| serious Total, serious adverse events | 9 / 278 | 14 / 278 | 15 / 241 | 4 / 121 | 1 / 119 |
Outcome results
Primary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22
The primary efficacy endpoint was the response difference (RD) of 20% improvement in ACR core set measurements (ACR20) at week 22. 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 week 22
Population: Intent-to-treat population; Participants with missing data at week 22 were counted as non-responders
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABP 710 | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22 | 68.1 percentage of participants |
| Infliximab | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22 | 59.1 percentage of participants |
Comparison: For the primary analysis of ACR20, the response difference (RD) was estimated by the Mantel-Haenszel (MH) estimate and the 90% confidence intervals (CIs) of RD were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use for RA).90% CI: [2.67, 15.96]
Comparison: A sensitivity analysis with the RD estimate and CIs for RD of ACR20 estimated using a generalized linear model with geographic region and prior biologic use for RA as covariates was also conducted.90% CI: [2.67, 15.92]
Comparison: A post-hoc analysis was conducted to adjust for the impact of random imbalance in baseline demographic and disease characteristics between the 2 treatment groups. The MH estimate of RD and corresponding CIs were estimated using a nonparametric analysis of covariance method with stratification factors geographic region and prior biologic use, and adjustment for baseline covariates (ACR core set, age, use of oral corticosteroid, use of NSAID, body mass index categories, and methotrexate dose).90% CI: [0.748, 13.62]
Secondary
Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22
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 30, 34, 38, 46, and 50
Population: Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22) and with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 30 | -2.07 units on a scale | Standard Deviation 1.278 |
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 46 | -2.11 units on a scale | Standard Deviation 1.381 |
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 34 | -2.32 units on a scale | Standard Deviation 1.306 |
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 38 | -2.20 units on a scale | Standard Deviation 1.277 |
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 50 | -2.45 units on a scale | Standard Deviation 1.365 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 50 | -2.49 units on a scale | Standard Deviation 1.276 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 38 | -2.27 units on a scale | Standard Deviation 1.301 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 46 | -2.27 units on a scale | Standard Deviation 1.387 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 34 | -2.46 units on a scale | Standard Deviation 1.372 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 30 | -2.25 units on a scale | Standard Deviation 1.379 |
| Infliximab / ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 38 | -2.32 units on a scale | Standard Deviation 1.4 |
| Infliximab / ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 30 | -2.22 units on a scale | Standard Deviation 1.266 |
| Infliximab / ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 46 | -2.26 units on a scale | Standard Deviation 1.44 |
| Infliximab / ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 50 | -2.64 units on a scale | Standard Deviation 1.328 |
| Infliximab / ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22 | Week 34 | -2.45 units on a scale | Standard Deviation 1.309 |
Comparison: Week 30 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.08, 0.4]
Comparison: Week 30 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.27, 0.28]
Comparison: Week 34 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.12, 0.35]
Comparison: Week 34 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.3, 0.24]
Comparison: Week 38 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.18, 0.3]
Comparison: Week 38 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.36, 0.2]
Comparison: Week 46 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.14, 0.37]
Comparison: Week 46 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.34, 0.25]
Comparison: Week 50 difference between means (ABP 710/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.24, 0.24]
Comparison: Week 50 difference between means (Infliximab/ABP 710 minus Infliximab/Infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.47, 0.08]
Secondary
Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22
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 2, 6, 14, and 22
Population: Intent-to-treat population with available data at each time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Week 6 | -1.82 units on a scale | Standard Deviation 1.222 |
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Week 14 | -1.95 units on a scale | Standard Deviation 1.218 |
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Week 22 | -2.06 units on a scale | Standard Deviation 1.29 |
| ABP 710 | Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Week 2 | -1.36 units on a scale | Standard Deviation 0.991 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Week 22 | -2.06 units on a scale | Standard Deviation 1.296 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Week 14 | -1.91 units on a scale | Standard Deviation 1.289 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Week 2 | -1.29 units on a scale | Standard Deviation 1.006 |
| Infliximab | Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22 | Week 6 | -1.82 units on a scale | Standard Deviation 1.203 |
Comparison: Week 2 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.2, 0.007]
Comparison: Week 6 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.17, 0.16]
Comparison: Week 14 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.21, 0.14]
Comparison: Week 22 difference between means (ABP 710 minus infliximab) and 90% CIs for difference between means were based on ANCOVA model with the DAS28-CRP change from baseline as the response and adjusted for the baseline DAS28-CRP measurement and the actual stratification factors: geographic region and prior biologic use for RA.90% CI: [-0.2, 0.17]
Secondary
Percentage of Participants With an ACR20 Response After Week 22
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 30, 34, 38, 46, and 50
Population: Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 46 | 61.9 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 38 | 70.5 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 30 | 69.7 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 34 | 74.6 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 50 | 67.6 percentage of participants |
| Infliximab | Percentage of Participants With an ACR20 Response After Week 22 | Week 38 | 69.4 percentage of participants |
| Infliximab | Percentage of Participants With an ACR20 Response After Week 22 | Week 30 | 66.9 percentage of participants |
| Infliximab | Percentage of Participants With an ACR20 Response After Week 22 | Week 34 | 71.1 percentage of participants |
| Infliximab | Percentage of Participants With an ACR20 Response After Week 22 | Week 46 | 65.3 percentage of participants |
| Infliximab | Percentage of Participants With an ACR20 Response After Week 22 | Week 50 | 72.7 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 50 | 70.6 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 46 | 66.4 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 30 | 74.8 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 38 | 72.3 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR20 Response After Week 22 | Week 34 | 74.8 percentage of participants |
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-5.26, 11.73]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-1.18, 17.97]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-4.61, 11.7]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-5.4, 13.4]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-7.34, 9.4]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-6.86, 12.34]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-12.27, 5.17]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-8.89, 11.08]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-13.24, 3.29]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-11.01, 8.04]
Secondary
Percentage of Participants With an ACR20 Response Through Week 14
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 2, 6, and 14
Population: Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABP 710 | Percentage of Participants With an ACR20 Response Through Week 14 | Week 6 | 64.9 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR20 Response Through Week 14 | Week 14 | 66.3 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR20 Response Through Week 14 | Week 2 | 46.2 percentage of participants |
| Infliximab | Percentage of Participants With an ACR20 Response Through Week 14 | Week 2 | 38.0 percentage of participants |
| Infliximab | Percentage of Participants With an ACR20 Response Through Week 14 | Week 6 | 59.9 percentage of participants |
| Infliximab | Percentage of Participants With an ACR20 Response Through Week 14 | Week 14 | 60.2 percentage of participants |
Comparison: The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [1.15, 14.81]
Comparison: The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-1.8, 11.64]
Comparison: The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-0.51, 12.87]
Secondary
Percentage of Participants With an ACR50 Response After Week 22
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 30, 34, 38, 46, and 50
Population: Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 30 | 43.0 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 46 | 43.9 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 38 | 48.0 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 50 | 49.2 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 34 | 52.5 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response After Week 22 | Week 38 | 47.1 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response After Week 22 | Week 30 | 44.6 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response After Week 22 | Week 34 | 46.3 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response After Week 22 | Week 46 | 44.6 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response After Week 22 | Week 50 | 54.5 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 50 | 57.1 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 46 | 50.4 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 30 | 47.1 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 38 | 49.6 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR50 Response After Week 22 | Week 34 | 56.3 percentage of participants |
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-10.4, 7.62]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-7.28, 13.67]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-2.62, 15.48]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [0.12, 21.03]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-8.54, 9.59]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-7.62, 13.39]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-10.11, 7.93]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-4.44, 16.54]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-14.39, 3.71]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-7.51, 13.37]
Secondary
Percentage of Participants With an ACR50 Response Through Week 22
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 2, 6, 14, and 22
Population: Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABP 710 | Percentage of Participants With an ACR50 Response Through Week 22 | Week 2 | 17.2 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR50 Response Through Week 22 | Week 6 | 30.1 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR50 Response Through Week 22 | Week 14 | 39.4 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR50 Response Through Week 22 | Week 22 | 43.0 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response Through Week 22 | Week 22 | 36.2 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response Through Week 22 | Week 2 | 12.5 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response Through Week 22 | Week 14 | 36.9 percentage of participants |
| Infliximab | Percentage of Participants With an ACR50 Response Through Week 22 | Week 6 | 28.3 percentage of participants |
Comparison: The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-0.56, 9.38]
Comparison: The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-4.71, 7.94]
Comparison: The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-4.45, 9.03]
Comparison: The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [0.27, 13.83]
Secondary
Percentage of Participants With an ACR70 Response After Week 22
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 30, 34, 38, 46, and 50
Population: Participants re-randomized at week 22 (includes participants initially randomized to ABP 710 who continued treatment with ABP 710 at week 22); participants with missing data at a given visit were counted as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 30 | 26.6 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 38 | 29.1 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 50 | 34.0 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 46 | 29.5 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 34 | 29.5 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response After Week 22 | Week 34 | 28.1 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response After Week 22 | Week 30 | 26.4 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response After Week 22 | Week 38 | 29.8 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response After Week 22 | Week 46 | 29.8 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response After Week 22 | Week 50 | 32.2 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 30 | 26.1 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 50 | 43.7 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 46 | 37.0 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 38 | 32.8 percentage of participants |
| Infliximab / ABP 710 | Percentage of Participants With an ACR70 Response After Week 22 | Week 34 | 35.3 percentage of participants |
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-8.12, 8.02]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 30 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-9.39, 9.28]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-7, 9.51]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 34 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-2.39, 17.22]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-9.03, 7.59]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 38 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-6.41, 13.14]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-8.98, 7.66]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 46 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-2.13, 17.68]
Comparison: The response difference (ABP 710/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-6.81, 10.29]
Comparison: The response difference (Infliximab/ABP 710 minus Infliximab/Infliximab) at week 50 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [1.74, 22.04]
Secondary
Percentage of Participants With an ACR70 Response Through Week 22
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 2, 6, 14, and 22
Population: Intent-to-treat population; participants with missing data at a given visit were counted as non-responders.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ABP 710 | Percentage of Participants With an ACR70 Response Through Week 22 | Week 2 | 3.9 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR70 Response Through Week 22 | Week 6 | 14.3 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR70 Response Through Week 22 | Week 14 | 21.9 percentage of participants |
| ABP 710 | Percentage of Participants With an ACR70 Response Through Week 22 | Week 22 | 24.0 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response Through Week 22 | Week 22 | 19.7 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response Through Week 22 | Week 2 | 6.5 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response Through Week 22 | Week 14 | 16.1 percentage of participants |
| Infliximab | Percentage of Participants With an ACR70 Response Through Week 22 | Week 6 | 16.5 percentage of participants |
Comparison: The response difference at week 2 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-5.84, 0.83]
Comparison: The response difference at week 6 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-7.47, 2.64]
Comparison: The response difference at week 14 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-0.01, 10.91]
Comparison: The response difference at week 22 was estimated by the Mantel-Haenszel estimate; 90% confidence intervals were estimated from the stratified Newcombe confidence limits, adjusting for actual stratification factors (geographic region and prior biologic use).90% CI: [-1.21, 10.34]