Arthritis, RheumatoidPhase 3NCT02937701
Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab
A Phase 3 study testing ABP 710 and Infliximab in people with Arthritis, Rheumatoid, run by Amgen at 73 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- ABP 710 and Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 73 sitesin 9 countries
- Study dates
- 10 Oct 2016to 13 Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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).
Show all 28Show fewer
- 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.
Trial locations and contacts
73 sites in 9 countries.
73 sites in 9 countries
United States26 sites
Research Site
Aventura, Florida, 33180
Research Site
Carrollton, Texas, 75007-1601
Research Site
Charleston, South Carolina, 29406-9333
Research Site
Charlotte, North Carolina, 28210
Research Site
Covina, California, 91722
Research Site
Dallas, Texas, 75231
Research Site
Flowood, Mississippi, 39232
Research Site
Grand Blanc, Michigan, 48439
Research Site
Hemet, California, 92543-4403
Research Site
Houston, Texas, 77429-5890
Research Site
Huntsville, Alabama, 35801
Research Site
League City, Texas, 77573
Research Site
Lexington, Kentucky, 40504
Research Site
Memphis, Tennessee, 38119
Research Site
Miami Lakes, Florida, 33014
Research Site
Omaha, Nebraska, 68114
Research Site
Orlando, Florida, 32804
Research Site
Peoria, Arizona, 85381
Research Site
Plano, Texas, 75024
Research Site
Sarasota, Florida, 34239
Research Site
St Louis, Missouri, 63141
Research Site
Tuscaloosa, Alabama, 35406
Research Site
Upland, California, 91786
Research Site
Van Nuys, California, 91405
Research Site
Vero Beach, Florida, 32960
Research Site
Voorhees Township, New Jersey, 08043
Poland18 sites
Research Site
Bialystok, Podlaskie Voivodeship, 15-099
Research Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168
Research Site
Elblag, Warmian-Masurian Voivodeship, 82-300
Research Site
Gdansk, Pomeranian Voivodeship, 80-382
Research Site
Katowice, Silesian Voivodeship, 40-282
Research Site
Krakow, Lesser Poland Voivodeship, 30-033
Research Site
Lodz, Łódź Voivodeship, 91-363
Research Site
Lublin, Lublin Voivodeship, 20-582
Research Site
Poznan, Greater Poland Voivodeship, 60-218
Research Site
Poznan, Greater Poland Voivodeship, 60-529
Research Site
Poznan, Greater Poland Voivodeship, 60-693
Research Site
Poznan, Greater Poland Voivodeship, 61-113
Research Site
Poznan, Greater Poland Voivodeship, 61-397
Research Site
Stalowa Wola, Podkarpackie Voivodeship, 37-450
Research Site
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Research Site
Warsaw, Masovian Voivodeship, 01-192
Research Site
Warsaw, Masovian Voivodeship, 02-691
Research Site
Wroclaw, Lower Silesian Voivodeship, 50-381
Czechia8 sites
Research Site
Brno, Jihormoravsky KRAJ, 602 00
Research Site
Hlučín, Moravian-Silesian Region, 748 01
Research Site
Liberec, Severocesky KRAJ, 460 01
Research Site
Ostrava, Severomoravsky KRAJ, 702 00
Research Site
Pardubice, Vychodocesky KRAJ, 530 02
Research Site
Prague, Prague, 128 50
Research Site
Prague, Prague, 130 00
Research Site
Zlín, Severomoravsky KRAJ, 760 01
Bulgaria6 sites
Research Site
Pleven, 5800
Research Site
Plovdiv, 4002
Research Site
Plovdiv, 4003
Research Site
Sliven, 8800
Research Site
Sofia, Sofia, 1606
Research Site
Varna, 9005
Germany4 sites
Research Site
Bad Doberan, Mecklenburg-Vorpommern, 18209
Research Site
Hamburg, 20095
Research Site
Hildesheim, Lower Saxony, 31134
Research Site
Magdeburg, Saxony-Anhalt, 39120
Hungary4 sites
Research Site
Győr, Győr-Moson-Sopron, 9024
Research Site
Gyula, Bekes County, 5700
Research Site
Szentes, Csongrád megye, 6600
Research Site
Veszprém, Veszprém megye, 8200
Spain3 sites
Research Site
Barcelona, 08028
Research Site
Madrid, 28041
Research Site
Seville, 41010
Australia2 sites
Research Site
Fitzroy, Victoria, 3065
Research Site
Woodville, South Australia, 5011
Canada2 sites
Research Site
Saint Johns, Newfoundland and Labrador, A1A 5E8
Research Site
Victoria, British Columbia, V8V 3M9
About this study
Official title: A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis
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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- ABP 710, Infliximab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP 710Biological
Administered by intravenous infusion
InfliximabBiological
Also called Remicade®
Administered by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| ABP 710 | Experimental | 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.
At week 22 participants continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46. Receives: Biological: ABP 710 |
| Infliximab | Active comparator | Participants randomized to receive a 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 were re-randomized in a 1:1 ratio to either continue receiving 3 mg/kg infliximab every 8 weeks or transition to receive 3 mg/kg ABP 710 every 8 weeks through week 46. Receives: Biological: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and week 22
Secondary outcomes (8)
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.
Measured: Baseline and weeks 2, 6, and 14
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.
Measured: Baseline and weeks 30, 34, 38, 46, and 50
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.
Measured: Baseline and weeks 2, 6, 14, and 22
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.
Measured: Baseline and weeks 30, 34, 38, 46, and 50
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.
Measured: Baseline and weeks 2, 6, 14, and 22
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.
Measured: Baseline and weeks 30, 34, 38, 46, and 50
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.
Measured: Baseline and weeks 2, 6, 14, and 22
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.
Measured: Baseline and weeks 30, 34, 38, 46, and 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start10 Oct 2016
- Primary completion16 Apr 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937701
- Sponsor's protocol ID
- 20140111
- Other IDs
- 2014-004704-29, 2014
- Status last verified
- Aug 2019
- First submitted
- 30 Aug 2016
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Genovese MC, Sanchez-Burson J, Oh M, Balazs E, Neal J, Everding A, Hala T, Wojciechowski R, Fanjiang G, Cohen S. Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 Mar 26;22(1):60. doi: 10.1186/s13075-020-2142-1.
PubMed 32216829
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Phase 3 Study to Assess the Efficacy and Safety of ABP 710 Compared to Infliximab in Subjects With Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02937701
- Acronym / sponsor ID
- 20140111
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 16 Apr 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABP 710 | Experimental | Biological: ABP 710Participants 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. At week 22 participants continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46. |
| Infliximab | Active comparator | Biological: InfliximabParticipants randomized to receive a 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 were re-randomized in a 1:1 ratio to either continue receiving 3 mg/kg infliximab every 8 weeks or transition to receive 3 mg/kg ABP 710 every 8 weeks through week 46. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
- Subject has a positive rheumatoid factor or anti-cyclic citrullinated peptide at screening.
Key exclusion criteria (28 listed)
- Subject has a history of prosthetic or native joint infection.
- Subject has an active infection or history of infections as follows:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABP 710Administered by intravenous infusion | Biological | ABP 710 |
| InfliximabAlso: Remicade®Administered by intravenous infusion | Biological | Infliximab |
Primary outcome
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22
Time frame: 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.
8 secondary outcomes
Percentage of Participants With an ACR20 Response Through Week 14
Time frame: Baseline and weeks 2, 6, and 14
Percentage of Participants With an ACR20 Response After Week 22
Time frame: Baseline and weeks 30, 34, 38, 46, and 50
Percentage of Participants With an ACR50 Response Through Week 22
Time frame: Baseline and weeks 2, 6, 14, and 22
Percentage of Participants With an ACR50 Response After Week 22
Time frame: Baseline and weeks 30, 34, 38, 46, and 50
Percentage of Participants With an ACR70 Response Through Week 22
Time frame: Baseline and weeks 2, 6, 14, and 22
Percentage of Participants With an ACR70 Response After Week 22
Time frame: Baseline and weeks 30, 34, 38, 46, and 50
Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22
Time frame: Baseline and weeks 2, 6, 14, and 22
Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22
Time frame: Baseline and weeks 30, 34, 38, 46, and 50
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32216829Genovese MC, Sanchez-Burson J, Oh M, Balazs E, Neal J, Everding A, Hala T, Wojciechowski R, Fanjiang G, Cohen S. Comparative clinical efficacy and safety of the proposed biosimilar ABP 710 with infliximab reference product in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 Mar 26;22(1):60. doi: 10.1186/s13075-020-2142-1.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
73 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABP 710 and Infliximab in people with Arthritis, Rheumatoid, run by Amgen at 73 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in United States, Poland, Czechia, Bulgaria, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22 (time frame: Baseline and week 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02937701, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.