Study to Assess if ABP710 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Infliximab

NCT ID: NCT02937701

Last Updated: 2019-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-10
• Study Completion Date: 2018-08-13

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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

At week 22 participants continued receiving 3 mg/kg ABP 710 every 8 weeks through week 46.

Group Type: EXPERIMENTAL

ABP 710

Intervention Type: BIOLOGICAL

Administered by intravenous infusion

Infliximab

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.

Group Type: ACTIVE_COMPARATOR

Infliximab

Intervention Type: BIOLOGICAL

Administered by intravenous infusion

Interventions

ABP 710

Administered by intravenous infusion

Intervention Type: BIOLOGICAL

Infliximab

Administered by intravenous infusion

Intervention Type: BIOLOGICAL

Other Intervention Names

Remicade®

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

Locations

Research Site

Huntsville, Alabama, United States

Research Site

Tuscaloosa, Alabama, United States

Research Site

Peoria, Arizona, United States

Research Site

Covina, California, United States

Research Site

Hemet, California, United States

Research Site

Upland, California, United States

Research Site

Van Nuys, California, United States

Research Site

Aventura, Florida, United States

Research Site

Miami Lakes, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Sarasota, Florida, United States

Research Site

Vero Beach, Florida, United States

Research Site

Lexington, Kentucky, United States

Research Site

Grand Blanc, Michigan, United States

Research Site

Flowood, Mississippi, United States

Research Site

St Louis, Missouri, United States

Research Site

Omaha, Nebraska, United States

Research Site

Voorhees Township, New Jersey, United States

Research Site

Charlotte, North Carolina, United States

Research Site

Charleston, South Carolina, United States

Research Site

Memphis, Tennessee, United States

Research Site

Carrollton, Texas, United States

Research Site

Dallas, Texas, United States

Research Site

Houston, Texas, United States

Research Site

League City, Texas, United States

Research Site

Plano, Texas, United States

Research Site

Woodville, South Australia, Australia

Research Site

Fitzroy, Victoria, Australia

Research Site

Sofia, Sofia, Bulgaria

Research Site

Pleven, , Bulgaria

Research Site

Plovdiv, , Bulgaria

Research Site

Plovdiv, , Bulgaria

Research Site

Sliven, , Bulgaria

Research Site

Varna, , Bulgaria

Research Site

Victoria, British Columbia, Canada

Research Site

Saint Johns, Newfoundland and Labrador, Canada

Research Site

Brno, Jihormoravsky KRAJ, Czechia

Research Site

Hlučín, Moravskoslezský kraj, Czechia

Research Site

Prague, Prague, Czechia

Research Site

Prague, Prague, Czechia

Research Site

Liberec, Severocesky KRAJ, Czechia

Research Site

Ostrava, Severomoravsky KRAJ, Czechia

Research Site

Zlín, Severomoravsky KRAJ, Czechia

Research Site

Pardubice, Vychodocesky KRAJ, Czechia

Research Site

Hildesheim, Lower Saxony, Germany

Research Site

Bad Doberan, Mecklenburg-Vorpommern, Germany

Research Site

Magdeburg, Saxony-Anhalt, Germany

Research Site

Hamburg, , Germany

Research Site

Gyula, Bekes County, Hungary

Research Site

Szentes, Csongrád megye, Hungary

Research Site

Győr, Győr-Moson-Sopron, Hungary

Research Site

Veszprém, Veszprém megye, Hungary

Research Site

Poznan, Greater Poland Voivodeship, Poland

Research Site

Poznan, Greater Poland Voivodeship, Poland

Research Site

Poznan, Greater Poland Voivodeship, Poland

Research Site

Poznan, Greater Poland Voivodeship, Poland

Research Site

Poznan, Greater Poland Voivodeship, Poland

Research Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Research Site

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Research Site

Krakow, Lesser Poland Voivodeship, Poland

Research Site

Wroclaw, Lower Silesian Voivodeship, Poland

Research Site

Lublin, Lublin Voivodeship, Poland

Research Site

Warsaw, Masovian Voivodeship, Poland

Research Site

Warsaw, Masovian Voivodeship, Poland

Research Site

Stalowa Wola, Podkarpackie Voivodeship, Poland

Research Site

Bialystok, Podlaskie Voivodeship, Poland

Research Site

Gdansk, Pomeranian Voivodeship, Poland

Research Site

Katowice, Silesian Voivodeship, Poland

Research Site

Elblag, Warmian-Masurian Voivodeship, Poland

Research Site

Lodz, Łódź Voivodeship, Poland

Research Site

Barcelona, , Spain

Research Site

Madrid, , Spain

Research Site

Seville, , Spain

Countries

United States; Australia; Bulgaria; Canada; Czechia; Germany; Hungary; Poland; Spain

References

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.

Reference Type: DERIVED

PMID: 32216829 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

2014-004704-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

20140111

Identifier Type: -

Identifier Source: org_study_id