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

NCT02937701 | Completed Phase 3 Results DMC

• 2 other identifiers: 201401112014-004704-29
• Study Type: interventional
• Target: 558
• Locations: 9 countries
• Sites: 73

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and week 22

Secondary Outcomes (8)

• Percentage of Participants With an ACR20 Response Through Week 14

  Baseline and weeks 2, 6, and 14

• Percentage of Participants With an ACR20 Response After Week 22

  Baseline and weeks 30, 34, 38, 46, and 50

• Percentage of Participants With an ACR50 Response Through Week 22

  Baseline and weeks 2, 6, 14, and 22

• Percentage of Participants With an ACR50 Response After Week 22

  Baseline and weeks 30, 34, 38, 46, and 50

• Percentage of Participants With an ACR70 Response Through Week 22

  Baseline and weeks 2, 6, 14, and 22

Study Arms (2)

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.

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.

Biological: Infliximab

Interventions

ABP 710 BIOLOGICAL

Administered by intravenous infusion

ABP 710

Infliximab BIOLOGICAL

Administered by intravenous infusion

Also known as: Remicade®

Infliximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (73)

Research Site

Huntsville, Alabama, 35801, United States

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Tuscaloosa, Alabama, 35406, United States

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Peoria, Arizona, 85381, United States

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Covina, California, 91722, United States

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Hemet, California, 92543-4403, United States

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Upland, California, 91786, United States

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Van Nuys, California, 91405, United States

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Aventura, Florida, 33180, United States

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Miami Lakes, Florida, 33014, United States

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Orlando, Florida, 32804, United States

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Sarasota, Florida, 34239, United States

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Vero Beach, Florida, 32960, United States

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Lexington, Kentucky, 40504, United States

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Grand Blanc, Michigan, 48439, United States

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Flowood, Mississippi, 39232, United States

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St Louis, Missouri, 63141, United States

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Omaha, Nebraska, 68114, United States

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Voorhees Township, New Jersey, 08043, United States

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Charlotte, North Carolina, 28210, United States

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Charleston, South Carolina, 29406-9333, United States

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Memphis, Tennessee, 38119, United States

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Carrollton, Texas, 75007-1601, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77429-5890, United States

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League City, Texas, 77573, United States

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Plano, Texas, 75024, United States

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Woodville, South Australia, 5011, Australia

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Fitzroy, Victoria, 3065, Australia

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Sofia, Sofia, 1606, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Plovdiv, 4003, Bulgaria

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Sliven, 8800, Bulgaria

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Varna, 9005, Bulgaria

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Victoria, British Columbia, V8V 3M9, Canada

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Saint Johns, Newfoundland and Labrador, A1A 5E8, Canada

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Brno, Jihormoravsky KRAJ, 602 00, Czechia

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Hlučín, Moravskoslezský kraj, 748 01, Czechia

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Prague, Prague, 128 50, Czechia

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Prague, Prague, 130 00, Czechia

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Liberec, Severocesky KRAJ, 460 01, Czechia

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Ostrava, Severomoravsky KRAJ, 702 00, Czechia

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Zlín, Severomoravsky KRAJ, 760 01, Czechia

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Pardubice, Vychodocesky KRAJ, 530 02, Czechia

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Hildesheim, Lower Saxony, 31134, Germany

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Bad Doberan, Mecklenburg-Vorpommern, 18209, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Hamburg, 20095, Germany

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Gyula, Bekes County, 5700, Hungary

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Szentes, Csongrád megye, 6600, Hungary

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Győr, Győr-Moson-Sopron, 9024, Hungary

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Veszprém, Veszprém megye, 8200, Hungary

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Poznan, Greater Poland Voivodeship, 60-218, Poland

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Poznan, Greater Poland Voivodeship, 60-529, Poland

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Poznan, Greater Poland Voivodeship, 60-693, Poland

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Poznan, Greater Poland Voivodeship, 61-113, Poland

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Poznan, Greater Poland Voivodeship, 61-397, Poland

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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

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Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

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Krakow, Lesser Poland Voivodeship, 30-033, Poland

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Wroclaw, Lower Silesian Voivodeship, 50-381, Poland

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Lublin, Lublin Voivodeship, 20-582, Poland

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Warsaw, Masovian Voivodeship, 01-192, Poland

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Warsaw, Masovian Voivodeship, 02-691, Poland

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Stalowa Wola, Podkarpackie Voivodeship, 37-450, Poland

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Bialystok, Podlaskie Voivodeship, 15-099, Poland

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Gdansk, Pomeranian Voivodeship, 80-382, Poland

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Katowice, Silesian Voivodeship, 40-282, Poland

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Elblag, Warmian-Masurian Voivodeship, 82-300, Poland

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Lodz, Łódź Voivodeship, 91-363, Poland

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Barcelona, 08028, Spain

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Madrid, 28041, Spain

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Seville, 41010, Spain

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Related Publications (1)

• 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.

  PMID: 32216829 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: October 19, 2016
• Study Start: October 10, 2016
• Primary Completion: April 16, 2018
• Study Completion: August 13, 2018
• Last Updated: August 28, 2019
• Results First Posted: August 28, 2019

Record last verified: 2019-08

Locations

HU (4); CA (2); US (26); DE (4); ES (3); PL (18); BU (6); AU (2); CZ (8)