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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02937701
First received: August 30, 2016
Last updated: April 4, 2017
Last verified: March 2017
  Purpose

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 710, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, infliximab, in patients with moderate or severe rheumatoid arthritis (RA).

This study will assess if the investigational medicine is safe and effective in

treating moderate or severe RA compared to the licensed medicine.


Condition Intervention Phase
Arthritis, Rheumatoid
Drug: ABP 710
Drug: Infliximab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 22 [ Time Frame: Week 22 ]

Secondary Outcome Measures:
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 2 [ Time Frame: Week 2 ]
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 6 [ Time Frame: Week 6 ]
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 14 [ Time Frame: Week 14 ]
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 30 [ Time Frame: Week 30 ]
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 34 [ Time Frame: Week 34 ]
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 38 [ Time Frame: Week 38 ]
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) week 46 [ Time Frame: Week 46 ]
  • Response difference measured by 20% improvement in ACR core set measurements (ACR20) at week 50 [ Time Frame: Week 50 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 2 [ Time Frame: Week 2 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 6 [ Time Frame: Week 6 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 14 [ Time Frame: Week 14 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 22 [ Time Frame: Week 22 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 30 [ Time Frame: Week 30 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 34 [ Time Frame: Week 34 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 38 [ Time Frame: Week 38 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 46 [ Time Frame: Week 46 ]
  • Response difference measured by 50% improvement in ACR core set measurements (ACR50) at week 50 [ Time Frame: Week 50 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 2 [ Time Frame: Week 2 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 6 [ Time Frame: Week 6 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 14 [ Time Frame: Week 14 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 22 [ Time Frame: Week 22 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 30 [ Time Frame: Week 30 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 34 [ Time Frame: Week 34 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 38 [ Time Frame: Week 38 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 46 [ Time Frame: Week 46 ]
  • Response difference measured by 70% improvement in ACR core set measurements (ACR70) at week 50 [ Time Frame: Week 50 ]
  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 2 [ Time Frame: Week 2 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 6 [ Time Frame: Week 6 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 14 [ Time Frame: Week 14 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 22 [ Time Frame: Week 22 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 30 [ Time Frame: Week 30 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 34 [ Time Frame: Week 34 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) week 38 [ Time Frame: Week 38 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 46 [ Time Frame: Week 46 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Change in disease activity measured by the disease activity score in 28 joints - C-reactive protein (DAS28-CRP) at week 50 [ Time Frame: Week 50 ]

    The DAS28-CRP is a composite measure of disease activity in RA. It is a continuous

    measure based on 28 Disease Activity Score (DAS) joints from the ACR, the Subject's

    Global Health Assessment score and CRP.


  • Treatment-emergent adverse events, serious adverse events, and adverse events of special interest [ Time Frame: Baseline through Week 50 ]
  • Clinically significant changes in laboratory values and vital signs [ Time Frame: Baseline through Week 50 ]
  • Incidence of antidrug antibodies at baseline [ Time Frame: Baseline ]
  • Incidence of antidrug antibodies at week 2 [ Time Frame: Week 2 ]
  • Incidence of antidrug antibodies at week 6 [ Time Frame: Week 6 ]
  • Incidence of antidrug antibodies at week 14 [ Time Frame: Week 14 ]
  • Incidence of antidrug antibodies at week 22 [ Time Frame: Week 22 ]
  • Incidence of antidrug antibodies at week 30 [ Time Frame: Week 30 ]
  • Incidence of antidrug antibodies at week 34 [ Time Frame: Week 34 ]
  • Incidence of antidrug antibodies at week 38 [ Time Frame: Week 38 ]
  • Incidence of antidrug antibodies week 50 [ Time Frame: Week 50 ]

Other Outcome Measures:
  • Trough serum concentrations of ABP 710 and infliximab at week 2 [ Time Frame: Week 2 ]
  • Trough serum concentrations of ABP 710 and infliximab at week 6 [ Time Frame: Week 6 ]
  • Trough serum concentrations of ABP 710 and infliximab at week 14 [ Time Frame: Week 14 ]
  • Trough serum concentrations of ABP 710 and infliximab at week 22 [ Time Frame: Week 22 ]

Estimated Enrollment: 550
Actual Study Start Date: October 10, 2016
Estimated Study Completion Date: August 2, 2018
Estimated Primary Completion Date: April 12, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABP 710
Concentrate for solution, ABP 710 3 mg/kg infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter
Drug: ABP 710
Concentrate for solution, ABP 710 3 mg/kg infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter
Active Comparator: infliximab
Concentrate for solution, infliximab 3 mg/kg infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter
Drug: Infliximab
Concentrate for solution, Infliximab 3 mg/kg infusion on day 1, at weeks 2 and 6, and every 8 weeks thereafter
Other Name: Remicade®

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject (man or woman) is ≥ 18 and ≤ 80 years old.
  • Subject is diagnosed with RA as determined by meeting the 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 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 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.
  • 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.
    • Woman who is of childbearing potential (ie, neither surgically sterile nor postmenopausal) and does 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02937701

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 55 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02937701     History of Changes
Other Study ID Numbers: 20140111
2014-004704-29 ( EudraCT Number )
Study First Received: August 30, 2016
Last Updated: April 4, 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pharmaceutical Solutions
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on April 26, 2017