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Trial record 2 of 75 for:    ABP-798

Study to Assess if ABP798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Rituximab

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ClinicalTrials.gov Identifier: NCT02792699
Recruitment Status : Completed
First Posted : June 7, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, 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, rituximab, in patients with moderate or severe 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 or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: ABP 798 Drug: Rituximab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study to Compare Pharmacokinetics and Pharmacodynamics, Efficacy and Safety of ABP 798 With Rituximab in Subjects With Moderate to Severe Rheumatoid Arthritis
Actual Study Start Date : May 17, 2016
Actual Primary Completion Date : October 8, 2018
Actual Study Completion Date : October 8, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: ABP 798
Concentrate for solution, ABP 798 IV infusion x 2 at baseline and repeat at week 24.
Drug: ABP 798
Active Comparator: Rituximab (US)
Concentrate for solution, Rituxan IV infusion x 2 at baseline and repeat at week 24.
Drug: ABP 798
Drug: Rituximab
Other Names:
  • Rituxan
  • MabThera

Active Comparator: Rituximab (EU)
Concentrate for solution, MabThera IV infusion x 2 at baseline and repeat at week 24.
Drug: Rituximab
Other Names:
  • Rituxan
  • MabThera




Primary Outcome Measures :
  1. Area under the serum concentration-time curve (AUCinf) [ Time Frame: Day 15 ]
    Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) following second infusion of the first dose

  2. Maximum serum concentration (Cmax) [ Time Frame: Day 15 ]
    Cmax following second infusion of the first dose


Secondary Outcome Measures :
  1. ACR [American College of Rheumatology] improvement in core set measurements [ Time Frame: Week 24 ]
  2. Disease Activity Score 28-CRP [ Time Frame: Week 24 ]
  3. Subject incidence of adverse events and serious adverse events [ Time Frame: Weeks 24 and 48 ]
  4. Incidence of anti-drug antibodies [ Time Frame: Weeks 24 and 48 ]
  5. Pharmacodynamics (PD) endpoints will include the percent of subjects with complete depletion in CD19+ cell count [ Time Frame: Days 1 to 3 ]
  6. AUC from time 0 on day 1 prior to the first infusion of the first dose to day 14 (AUC 0-14 day) [ Time Frame: Day 1 to day 14 ]
  7. AUC from time 0 on day 1 prior to the first infusion of the first dose to week 12 (AUC 0-12 wk) [ Time Frame: Day 1 to Week 12 ]
  8. Cmax [ Time Frame: Day 1 ]
    Cmax following the first infusion of the first dose

  9. Clinical significant changes in laboratory values [ Time Frame: Weeks 24 and 48 ]
  10. Clinical significant changes in vital signs [ Time Frame: Weeks 24 and 48 ]
  11. to demonstrate PK similarity between rituximab (US) and rituximab (EU) as [ Time Frame: Day 15 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Men or women ≥ 18 and ≤ 80 years old
  • Subjects must be diagnosed with Rheumatoid Arthritis for at least 6 months before baseline
  • Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and baseline and at least one of the following at screening:

    • erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr
    • serum C-reactive protein (CRP) > 1.0 mg/dL
  • Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational product (IP), and be willing to remain on a stable dose throughout the study
  • Subject has no known history of active tuberculosis

Exclusion Criteria:

  • Class IV RA, Felty's syndrome or history of prosthetic or native joint infection
  • Major chronic inflammatory disease or connective tissue disease other than RA, with the exception of secondary Sjögren's syndrome
  • Use of commercially available or investigational biologic therapies for RA as follows:

    • anakinra, etanercept within 1 month prior to first dose of IP
    • infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior to first dose of IP
    • other experimental or commercially available biologic therapies for RA within 3 months or 5 half-lives (whichever is longer) prior to first dose of IP
  • Previous receipt of rituximab or a biosimilar of rituximab

Other Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792699


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Locations
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United States, Alabama
Research Site
Tuscaloosa, Alabama, United States, 35406
United States, California
Research Site
Los Angeles, California, United States, 90095-1670
Research Site
Thousand Oaks, California, United States, 91360
Research Site
Upland, California, United States, 91786
United States, Florida
Research Site
Aventura, Florida, United States, 33180
Research Site
Edgewater, Florida, United States, 32132
Research Site
Hialeah, Florida, United States, 33012
Research Site
Orlando, Florida, United States, 32810
Research Site
Vero Beach, Florida, United States, 32960
United States, Idaho
Research Site
Idaho Falls, Idaho, United States, 83404
United States, Kentucky
Research Site
Lexington, Kentucky, United States, 40504
United States, Michigan
Research Site
Lansing, Michigan, United States, 48910
United States, Mississippi
Research Site
Flowood, Mississippi, United States, 39232
United States, Nevada
Research Site
Las Vegas, Nevada, United States, 89128
United States, North Carolina
Research Site
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Research Site
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Research Site
Charleston, South Carolina, United States, 29406-9333
Research Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Research Site
Memphis, Tennessee, United States, 38119
United States, Texas
Research Site
Carrollton, Texas, United States, 75007-1601
Research Site
Dallas, Texas, United States, 75231
Research Site
League City, Texas, United States, 77573
Research Site
Mesquite, Texas, United States, 75150
Research Site
Plano, Texas, United States, 75024
United States, Washington
Research Site
Olympia, Washington, United States, 98502
Research Site
Spokane, Washington, United States, 99204
Bulgaria
Research Site
Sofia, Sofiya, Bulgaria, 1233
Research Site
Sofia, Sofiya, Bulgaria, 1612
Research Site
Plovdiv, Bulgaria, 4003
Estonia
Research Site
Tallinn, Harjuma, Estonia, 10117
Research Site
Tartu, Estonia, 50106
Germany
Research Site
Bad Nauheim, Hessen, Germany, 61231
Research Site
Magdeburg, Sachsen-anhalt, Germany, 39120
Research Site
Berlin, Germany, 10117
Research Site
Berlin, Germany, 13125
Hungary
Research Site
Gyula, Bekes, Hungary, 5700
Research Site
Szentes, Csongrad, Hungary, 6600
Research Site
Budapest, Pest, Hungary, 1083
Research Site
Szombathely, VAS, Hungary, 9700
Research Site
Veszprém, Veszprem, Hungary, 8200
Poland
Research Site
Wrocław, Dolnoslaskie, Poland, 50-556
Research Site
Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
Research Site
Łódź, Lodzkie, Poland, 91-363
Research Site
Lublin, Lubelskie, Poland, 20-582
Research Site
Kraków, Malopolskie, Poland, 30-033
Research Site
Warszawa, Mazowieckie, Poland, 02-637
Research Site
Stalowa Wola, Podkarpackie, Poland, 37-450
Research Site
Białystok, Podlaskie, Poland, 15-297
Research Site
Gdańsk, Pomorskie, Poland, 80-382
Research Site
Katowice, Slaskie, Poland, 40-282
Research Site
Elbląg, Warminsko-mazurskie, Poland, 82-300
Research Site
Poznań, Wielkopolskie, Poland, 60-218
Research Site
Poznań, Wielkopolskie, Poland, 60-529
Research Site
Poznań, Wielkopolskie, Poland, 61-397
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02792699     History of Changes
Other Study ID Numbers: 20130108
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents