Clinical trial NCT02937701: Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Rheumatoid
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-10-19
Enrollment: 558
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 22
timeFrame: Baseline and week 22
Secondary outcomes:
measure: Percentage of Participants With an ACR20 Response Through Week 14
timeFrame: Baseline and weeks 2, 6, and 14
measure: Percentage of Participants With an ACR20 Response After Week 22
timeFrame: Baseline and weeks 30, 34, 38, 46, and 50
measure: Percentage of Participants With an ACR50 Response Through Week 22
timeFrame: Baseline and weeks 2, 6, 14, and 22
measure: Percentage of Participants With an ACR50 Response After Week 22
timeFrame: Baseline and weeks 30, 34, 38, 46, and 50
measure: Percentage of Participants With an ACR70 Response Through Week 22
timeFrame: Baseline and weeks 2, 6, 14, and 22
measure: Percentage of Participants With an ACR70 Response After Week 22
timeFrame: Baseline and weeks 30, 34, 38, 46, and 50
measure: Change From Baseline in Disease Activity Score 28 (DAS28) Through Week 22
timeFrame: Baseline and weeks 2, 6, 14, and 22
measure: Change From Baseline in Disease Activity Score 28 (DAS28) After Week 22
timeFrame: Baseline and weeks 30, 34, 38, 46, and 50
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Research Site
state: Alabama
city: Peoria
country: United States
facility: Research Site
state: Arizona
city: Covina
country: United States
facility: Research Site
state: California
city: Hemet
country: United States
facility: Research Site
state: California
city: Upland
country: United States
facility: Research Site
state: California
city: Van Nuys
country: United States
facility: Research Site
state: California
city: Aventura
country: United States
facility: Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Sarasota
country: United States
facility: Research Site
state: Florida
city: Vero Beach
country: United States
facility: Research Site
state: Florida
city: Lexington
country: United States
facility: Research Site
state: Kentucky
city: Grand Blanc
country: United States
facility: Research Site
state: Michigan
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Voorhees
country: United States
facility: Research Site
state: New Jersey
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charleston
country: United States
facility: Research Site
state: South Carolina
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Carrollton
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: League City
country: United States
facility: Research Site
state: Texas
city: Plano
country: United States
facility: Research Site
state: Texas
city: Woodville
country: Australia
facility: Research Site
state: South Australia
city: Fitzroy
country: Australia
facility: Research Site
state: Victoria
city: Sofia
country: Bulgaria
facility: Research Site
state: Sofiya
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sliven
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Saint Johns
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Brno
country: Czechia
facility: Research Site
state: Jihormoravsky KRAJ
city: Hlučín
country: Czechia
facility: Research Site
state: Moravskoslezsky
city: Praha 2
country: Czechia
facility: Research Site
state: Praha
city: Praha 3
country: Czechia
facility: Research Site
state: Praha
city: Liberec
country: Czechia
facility: Research Site
state: Severocesky KRAJ
city: Ostrava
country: Czechia
facility: Research Site
state: Severomoravsky KRAJ
city: Zlín
country: Czechia
facility: Research Site
state: Severomoravsky KRAJ
city: Pardubice
country: Czechia
facility: Research Site
state: Vychodocesky KRAJ
city: Bad Doberan
country: Germany
facility: Research Site
state: Mecklenburg-vorpommern
city: Hildesheim
country: Germany
facility: Research Site
state: Niedersachsen
city: Magdeburg
country: Germany
facility: Research Site
state: Sachsen-anhalt
city: Hamburg
country: Germany
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
state: Bekes
city: Szentes
country: Hungary
facility: Research Site
state: Csongrad
city: Győr
country: Hungary
facility: Research Site
state: Gyor-moson-sopron
city: Veszprém
country: Hungary
facility: Research Site
state: Veszprem
city: Wroclaw
country: Poland
facility: Research Site
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Research Site
state: Kujawsko-pomorskie
city: Toruń
country: Poland
facility: Research Site
state: Kujawsko-pomorskie
city: Łódź
country: Poland
facility: Research Site
state: Lodzkie
city: Lublin
country: Poland
facility: Research Site
state: Lubelskie
city: Kraków
country: Poland
facility: Research Site
state: Malopolskie
city: Warszawa
country: Poland
facility: Research Site
state: Mazowieckie
city: Warszawa
country: Poland
facility: Research Site
state: Mazowieckie
city: Stalowa Wola
country: Poland
facility: Research Site
state: Podkarpackie
city: Białystok
country: Poland
facility: Research Site
state: Podlaskie
city: Gdańsk
country: Poland
facility: Research Site
state: Pomorskie
city: Katowice
country: Poland
facility: Research Site
state: Slaskie
city: Elbląg
country: Poland
facility: Research Site
state: Warminsko-mazurskie
city: Poznan
country: Poland
facility: Research Site
state: Wielkopolskie
city: Poznań
country: Poland
facility: Research Site
state: Wielkopolskie
city: Poznań
country: Poland
facility: Research Site
state: Wielkopolskie
city: Poznań
country: Poland
facility: Research Site
state: Wielkopolskie
city: Poznań
country: Poland
facility: Research Site
state: Wielkopolskie
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.