A Phase 3 interventional study of ABP 501 and Adalimumab in Arthritis, Rheumatoid, sponsored by Amgen. Completed at 11 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-13.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the effectiveness and safety of ABP 501 against adalimumab (HUMIRA®) in adults with moderate to severe rheumatoid arthritis (RA) who have an inadequate response to methotrexate (MTX).
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 526 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other Inclusion/Exclusion criteria may apply
Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Biological: ABP 501
Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Biological: Adalimumab
Solution for subcutaneous injection in pre-filled syringe
Also known as: AMJEVITA™, Adalimumab-atto
Solution for subcutaneous injection in pre-filled syringe
Also known as: HUMIRA®
Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
Time frame: Baseline and Week 24
Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)
The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * C-reactive protein (CRP) level * Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable). The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity. A repeated measures analysis with the DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and the baseline DAS28-CRP measurement as predictors in the model was performed.
Time frame: Baseline and weeks 2, 4, 8, 12, 18, and 24
Percentage of Participants With an ACR20 Response at Week 2 and Week 8
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
Time frame: Baseline, week 2 and week 8
Percentage of Participants With an ACR50 Response at Week 24
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
Time frame: Baseline and week 24
Percentage of Participants With an ACR70 Response at Week 24
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 70% improvement in tender joint count; * ≥ 70% improvement in swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
Time frame: Baseline and Week 24
Number of Participants With Adverse Events
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: * fatal * life threatening (places the subject at immediate risk of death) * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
Time frame: From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.
Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab
Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay). Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.
Time frame: Up to week 26
This study was conducted at 92 centers in 12 countries in Europe, North America and Latin America. The first participant enrolled on 24 October 2013 and the last participant enrolled on 26 May 2014.
| Milestone | ABP 501 | Adalimumab |
|---|---|---|
| Started | 264 | 262 |
| Completed | 243 | 251 |
| Not completed | 21 | 11 |
| Withdrew: Withdrawal by subject | 11 | 6 |
| Withdrew: Adverse event | 7 | 3 |
| Withdrew: Lost to follow-up | 2 | 2 |
| Withdrew: Protocol violation | 1 | 0 |
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
| percentage of participants | ABP 501 | Adalimumab |
|---|---|---|
| Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24 | 74.6 | 72.4 |
The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: * The number of swollen and tender joints assessed using the 28-joint count; * C-reactive protein (CRP) level * Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable). The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity. A repeated measures analysis with the DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and the baseline DAS28-CRP measurement as predictors in the model was performed.
| units on a scale | ABP 501 | Adalimumab |
|---|---|---|
| Week 2 (n = 254, 252) | -1.01 ± 0.891 | -0.96 ± 0.890 |
| Week 4 (n = 255, 254) | -1.45 ± 1.048 | -1.42 ± 0.979 |
| Week 8 (n = 247, 255) | -1.79 ± 1.075 | -1.70 ± 1.093 |
| Week 12 (n = 245, 250) | -2.04 ± 1.112 | -1.93 ± 1.171 |
| Week 18 (n = 244, 250) | -2.30 ± 1.184 | -2.17 ± 1.189 |
| Week 24 (n = 243, 250) | -2.32 ± 1.237 | -2.32 ± 1.209 |
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
| percentage of participants | ABP 501 | Adalimumab |
|---|---|---|
| Week 2 (n = 254, 257) | 35.4 | 24.5 |
| Week 8 (n = 260, 261) | 63.5 | 62.5 |
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
| percentage of participants | ABP 501 | Adalimumab |
|---|---|---|
| Percentage of Participants With an ACR50 Response at Week 24 | 49.2 | 52.0 |
A participant was a responder if the following 3 criteria for improvement from Baseline were met: * ≥ 70% improvement in tender joint count; * ≥ 70% improvement in swollen joint count; and * ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient's assessment of pain (measured on a 100 mm visual analog scale \[VAS\]); * Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); * Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); * Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]); * C-Reactive Protein level.
| percentage of participants | ABP 501 | Adalimumab |
|---|---|---|
| Percentage of Participants With an ACR70 Response at Week 24 | 26.0 | 22.9 |
Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: * fatal * life threatening (places the subject at immediate risk of death) * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event.
| participants | ABP 501 | Adalimumab |
|---|---|---|
| Any adverse event (AE) | 132 | 143 |
| Adverse event ≥ grade 3 | 9 | 17 |
| Treatment-related adverse event (TRAE) | 50 | 55 |
| Treatment-related adverse event ≥ grade 3 | 3 | 2 |
| Serious adverse event (SAE) | 10 | 13 |
| Treatment-related serious adverse event | 4 | 1 |
| AE leading to discontinuation of study drug | 5 | 2 |
| TRAE leading to discontinuation of study drug | 4 | 1 |
| AE leading to discontinuation from study | 7 | 2 |
| TRAE leading to discontinuation from study | 5 | 0 |
Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay). Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.
| percentage of participants | ABP 501 | Adalimumab |
|---|---|---|
| Developing Binding Antibody | 38.3 | 38.2 |
| Developing Neutralizing Antibody | 9.1 | 11.1 |
Collected over From the time of first treatment but on or within 28 days following the last dose of study treatment; 26 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABP 501 | — | 10/264 (3.8%) | 17/264 (6.4%) |
| Adalimumab | — | 13/262 (5%) | 19/262 (7.3%) |
| Event | ABP 501 | Adalimumab |
|---|---|---|
| SepsisInfections and infestations | 2/264 | 0/262 |
| Acute myocardial infarctionCardiac disorders | 0/264 | 1/262 |
| Cardiac failure congestiveCardiac disorders | 0/264 | 1/262 |
| Myocardial infarctionCardiac disorders | 0/264 | 1/262 |
| Wolff-Parkinson-White syndromeCardiac disorders | 0/264 | 1/262 |
| Large intestinal obstructionGastrointestinal disorders | 0/264 | 1/262 |
| Corneal graft rejectionImmune system disorders | 0/264 | 1/262 |
| Arthritis bacterialInfections and infestations | 0/264 | 1/262 |
| GastroenteritisInfections and infestations | 0/264 | 1/262 |
| Pneumonia fungalInfections and infestations | 0/264 | 1/262 |
| Event | ABP 501 | Adalimumab |
|---|---|---|
| NasopharyngitisInfections and infestations | 17/264 | 19/262 |
The full analysis set (all randomized participants)
| Age, Continuous(years) | ABP 501 | Adalimumab | Total |
|---|---|---|---|
| Mean | 55.4 ± 11.88 | 56.3 ± 11.47 | 55.9 ± 11.67 |
| Age, Customized(participants) | ABP 501 | Adalimumab | Total |
|---|---|---|---|
| < 65 years | 205 | 197 | 402 |
| ≥ 65 years | 59 | 65 | 124 |
| Sex: Female, Male(Participants) | ABP 501 | Adalimumab | Total |
|---|---|---|---|
| Female | 214 | 212 | 426 |
| Male | 50 | 50 | 100 |
| Race/Ethnicity, Customized(participants) | ABP 501 | Adalimumab | Total |
|---|---|---|---|
| White | 251 | 249 | 500 |
| Black or African American | 9 | 12 | 21 |
| Asian | 3 | 0 | 3 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Other | 1 | 1 | 2 |
| Ethnicity(participants) | ABP 501 | Adalimumab | Total |
|---|---|---|---|
| Hispanic or Latino | 33 | 25 | 58 |
| Not Hispanic or Latino | 230 | 236 | 466 |
| Not Allowed to Collect | 1 | 1 | 2 |
| Geographic Region(participants) | ABP 501 | Adalimumab | Total |
|---|---|---|---|
| Eastern Europe | 169 | 168 | 337 |
| Western Europe | 22 | 20 | 42 |
| North America | 72 | 72 | 144 |
| Latin America | 1 | 2 | 3 |
| Prior Biological Use for Rheumatoid Arthritis (RA)(participants) | ABP 501 | Adalimumab | Total |
|---|---|---|---|
| Yes | 71 | 74 | 145 |
| No | 193 | 188 | 381 |
| Duration of RA(years) | ABP 501 | Adalimumab | Total |
|---|---|---|---|
| Mean | 9.41 ± 8.076 | 9.37 ± 8.047 | 9.39 ± 8.054 |
8 further baseline measures are reported on the registry.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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