Trial record 1 of 4 for:
ABP710 | Amgen [Exact]
Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab
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ClinicalTrials.gov Identifier: NCT02937701 |
Recruitment Status :
Completed
First Posted : October 19, 2016
Results First Posted : August 28, 2019
Last Update Posted : August 28, 2019
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Arthritis, Rheumatoid |
Interventions |
Biological: ABP 710 Biological: Infliximab |
Enrollment | 558 |
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. |
Arm/Group Title | ABP 710 | Infliximab | ABP 710 / ABP 710 | Infliximab / Infliximab | Infliximab / ABP 710 |
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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. | 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. | At week 22 participants initially randomized to ABP 710 continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46. | At week 22 participants initially randomized to infliximab were re-randomized to continue receiving 3 mg/kg infliximab every 8 weeks through week 46. | At week 22 participants initially randomized to infliximab were re-randomized to receive 3 mg/kg ABP 710 every 8 weeks through week 46. |
Period Title: Day 1 to Week 22 | |||||
Started | 279 | 279 | 0 | 0 | 0 |
Received Treatment | 278 | 278 | 0 | 0 | 0 |
Completed | 244 | 240 | 0 | 0 | 0 |
Not Completed | 35 | 39 | 0 | 0 | 0 |
Reason Not Completed | |||||
Adverse Event | 11 | 14 | 0 | 0 | 0 |
Protocol Specified Criteria | 7 | 7 | 0 | 0 | 0 |
Dissatisfied With Treatment Efficacy | 5 | 9 | 0 | 0 | 0 |
Withdrawal by Subject | 6 | 6 | 0 | 0 | 0 |
Death | 1 | 1 | 0 | 0 | 0 |
Protocol Violation | 1 | 1 | 0 | 0 | 0 |
Lost to Follow-up | 1 | 1 | 0 | 0 | 0 |
Physician Decision | 2 | 0 | 0 | 0 | 0 |
Other | 1 | 0 | 0 | 0 | 0 |
Period Title: Week 22 to Week 50 | |||||
Started | 0 | 0 | 244 | 121 | 119 |
Completed | 0 | 0 | 212 | 113 | 110 |
Not Completed | 0 | 0 | 32 | 8 | 9 |
Reason Not Completed | |||||
Adverse Event | 0 | 0 | 10 | 3 | 3 |
Dissatisfied with Treatment Efficacy | 0 | 0 | 10 | 3 | 2 |
Withdrawal by Subject | 0 | 0 | 8 | 2 | 1 |
Lost to Follow-up | 0 | 0 | 2 | 0 | 1 |
Physician Decision | 0 | 0 | 2 | 0 | 1 |
Other | 0 | 0 | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | ABP 710 | Infliximab | Total | |
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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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 279 | 279 | 558 | |
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The intent-to-treat analysis set included all randomized participants
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
55.0 (11.72) | 54.8 (11.42) | 54.9 (11.56) | ||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
< 65 years |
217 77.8%
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217 77.8%
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434 77.8%
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≥ 65 years |
62 22.2%
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62 22.2%
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124 22.2%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
Female |
214 76.7%
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223 79.9%
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437 78.3%
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Male |
65 23.3%
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56 20.1%
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121 21.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
Hispanic or Latino |
18 6.5%
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13 4.7%
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31 5.6%
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Not Hispanic or Latino |
261 93.5%
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266 95.3%
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527 94.4%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
White |
265 95.0%
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267 95.7%
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532 95.3%
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Black or African American |
12 4.3%
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12 4.3%
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24 4.3%
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Asian |
2 0.7%
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0 0.0%
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2 0.4%
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Geographic Region
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
Asia Pacific |
5 1.8%
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4 1.4%
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9 1.6%
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Europe |
220 78.9%
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222 79.6%
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442 79.2%
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North America |
54 19.4%
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53 19.0%
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107 19.2%
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Prior Biologic Use for Rheumatoid Arthritis
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
Yes |
77 27.6%
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81 29.0%
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158 28.3%
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No |
202 72.4%
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198 71.0%
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400 71.7%
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Duration of Rheumatoid Arthritis (RA)
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
8.72 (7.914) | 8.34 (7.604) | 8.53 (7.756) | ||
Swollen joint Count
[1] Mean (Standard Deviation) Unit of measure: Joints |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
14.595 (8.0507) | 14.730 (8.8315) | 14.663 (8.4428) | ||
[1]
Measure Description: A total of 66 joints were scored for presence or absence of swelling.
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Tender Joint Count
[1] Mean (Standard Deviation) Unit of measure: Joints |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
23.109 (12.1648) | 23.764 (13.3800) | 23.436 (12.7796) | ||
[1]
Measure Description: A total of 68 joints were scored for presence or absence of tenderness.
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Patient Global Health Assessment
[1] [2] Mean (Standard Deviation) Unit of measure: Mm |
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Number Analyzed | 278 participants | 278 participants | 556 participants | |
65.4 (18.13) | 64.1 (20.03) | 64.7 (19.10) | ||
[1]
Measure Description: The participant's overall assessment of their disease activity in the past week assessed on a 100 mm visual analog scale (VAS), where 0 mm = No RA activity at all and 100 mm = Worst RA activity imaginable.
[2]
Measure Analysis Population Description: Participants with available data
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Investigator's Global Health Assessment
[1] [2] Mean (Standard Deviation) Unit of measure: Mm |
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Number Analyzed | 278 participants | 278 participants | 556 participants | |
64.5 (15.88) | 64.1 (15.76) | 64.3 (15.81) | ||
[1]
Measure Description: The investigator's assessment of the participant's current disease activity assessed on a 100 mm VAS where 0 mm = no activity at all (symptom-free and no arthritis symptoms) and 100 mm = worst activity imaginable (maximum arthritis disease activity).
[2]
Measure Analysis Population Description: Participants with available data
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Patient's Assessment of Disease-related Pain
[1] Mean (Standard Deviation) Unit of measure: Mm |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
63.5 (20.30) | 61.5 (21.65) | 62.5 (20.99) | ||
[1]
Measure Description: The participant's assessment of their current level of pain assessed on a 100 mm horizontal VAS, where 0 mm = no pain at all and 100 mm = worst pain imaginable.
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Disability Index of the Health Assessment Questionnaire (HAQ-DI)
[1] [2] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 278 participants | 278 participants | 556 participants | |
1.44 (0.584) | 1.42 (0.617) | 1.43 (0.601) | ||
[1]
Measure Description: The HAQ-DI is a patient-reported questionnaire consisting of 20 questions in eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
[2]
Measure Analysis Population Description: Participants with available data
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C-reactive Protein (CRP) Concentration
[1] Mean (Standard Deviation) Unit of measure: mg/L |
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Number Analyzed | 279 participants | 279 participants | 558 participants | |
14.26 (20.171) | 14.64 (23.117) | 14.45 (21.675) | ||
[1]
Measure Description: C-reactive protein (CRP) is a protein found in blood. CRP levels rise in response to inflammation.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Amgen Inc. |
Phone: | 866-572-6436 |
EMail: | medinfo@amgen.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Amgen |
ClinicalTrials.gov Identifier: | NCT02937701 |
Other Study ID Numbers: |
20140111 2014-004704-29 ( EudraCT Number ) |
First Submitted: | August 30, 2016 |
First Posted: | October 19, 2016 |
Results First Submitted: | August 8, 2019 |
Results First Posted: | August 28, 2019 |
Last Update Posted: | August 28, 2019 |