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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 25, 2016
First Posted Date  ICMJE June 7, 2016
Last Update Posted Date October 12, 2018
Actual Study Start Date  ICMJE May 17, 2016
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
  • 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
  • Maximum serum concentration (Cmax) [ Time Frame: Day 15 ]
    Cmax following second infusion of the first dose
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02792699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • ACR [American College of Rheumatology] improvement in core set measurements [ Time Frame: Week 24 ]
  • Disease Activity Score 28-CRP [ Time Frame: Week 24 ]
  • Subject incidence of adverse events and serious adverse events [ Time Frame: Weeks 24 and 48 ]
  • Incidence of anti-drug antibodies [ Time Frame: Weeks 24 and 48 ]
  • Pharmacodynamics (PD) endpoints will include the percent of subjects with complete depletion in CD19+ cell count [ Time Frame: Days 1 to 3 ]
  • 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 ]
  • 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 ]
  • Cmax [ Time Frame: Day 1 ]
    Cmax following the first infusion of the first dose
  • Clinical significant changes in laboratory values [ Time Frame: Weeks 24 and 48 ]
  • Clinical significant changes in vital signs [ Time Frame: Weeks 24 and 48 ]
  • to demonstrate PK similarity between rituximab (US) and rituximab (EU) as [ Time Frame: Day 15 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2016)
  • ACR20 (20% improvement in ACR [American College of Rheumatology] core set measurements) [ Time Frame: Week 24 ]
    20% improvement in ACR core set compared to baseline
  • Disease Activity Score 28-CRP [ Time Frame: Week 24 ]
  • Subject incidence of adverse events and serious adverse events [ Time Frame: Weeks 24 and 48 ]
  • Incidence of anti-drug antibodies [ Time Frame: Weeks 24 and 48 ]
  • Pharmacodynamics (PD) endpoints will include the percent of subjects with complete depletion in CD19+ cell count [ Time Frame: Days 1 to 3 ]
  • 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 ]
  • 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 ]
  • Cmax [ Time Frame: Day 1 ]
    Cmax following the first infusion of the first dose
  • Clinical significant changes in laboratory values [ Time Frame: Weeks 24 and 48 ]
  • Clinical significant changes in vital signs [ Time Frame: Weeks 24 and 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess if ABP798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis Compared to Rituximab
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: ABP 798
  • Drug: Rituximab
    Other Names:
    • Rituxan
    • MabThera
Study Arms  ICMJE
  • Experimental: ABP 798
    Concentrate for solution, ABP 798 IV infusion x 2 at baseline and repeat at week 24.
    Intervention: Drug: ABP 798
  • Active Comparator: Rituximab (US)
    Concentrate for solution, Rituxan IV infusion x 2 at baseline and repeat at week 24.
    Interventions:
    • Drug: ABP 798
    • Drug: Rituximab
  • Active Comparator: Rituximab (EU)
    Concentrate for solution, MabThera IV infusion x 2 at baseline and repeat at week 24.
    Intervention: Drug: Rituximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 15, 2017)
311
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2016)
300
Actual Study Completion Date  ICMJE October 8, 2018
Actual Primary Completion Date October 8, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Estonia,   Germany,   Hungary,   Poland,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT02792699
Other Study ID Numbers  ICMJE 20130108
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP