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Trial record 2 of 49 for:    ABP798

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

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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Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
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:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents