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A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

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NCT01526057

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35294 United States
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Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Confirmed diagnosis of rheumatoid arthritis

- Meets Class I, II or III of the ACR 1991 Revised Criteria

- RA seropositivity

- Stable dose of methotrexate

- Inadequate response to TNF inhibitors

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Any prior treatment with lymphocyte depleting therapies

- History of active TB infection

- Known or screen test positive for specific viruses or indicators of viral infection

NCT01526057
Pfizer
Completed
A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)

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A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
A Randomized, Double-Blind, Study Comparing The Pharmacokinetics And Pharmacodynamics, And Assessing The Safety Of PF-05280586 And Rituximab In Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate Who Have Had An Inadequate Response To One Or More TNF Antagonist Therapies
In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: PF-05280586
    1000 mg, IV on days 1 and 15
  • Biological: MabThera
    1000 mg, IV on days 1 and 15
  • Biological: Rituxan
    1000 mg, IV on days 1 and 15
  • Experimental: A - PF-05280586
    Intervention: Biological: PF-05280586
  • Active Comparator: B - Rituximab EU
    Intervention: Biological: MabThera
  • Active Comparator: C- Rituximab-US
    Intervention: Biological: Rituxan
Williams JH, Hutmacher MM, Zierhut ML, Becker JC, Gumbiner B, Spencer-Green G, Melia LA, Liao KH, Suster M, Yin D, Li R, Meng X. Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab. Br J Clin Pharmacol. 2016 Dec;82(6):1568-1579. doi: 10.1111/bcp.13094. Epub 2016 Sep 22.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
222
May 2014
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of rheumatoid arthritis
  • Meets Class I, II or III of the ACR 1991 Revised Criteria
  • RA seropositivity
  • Stable dose of methotrexate
  • Inadequate response to TNF inhibitors

Exclusion Criteria:

  • Any prior treatment with lymphocyte depleting therapies
  • History of active TB infection
  • Known or screen test positive for specific viruses or indicators of viral infection
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Colombia,   Germany,   Israel,   Mexico,   Russian Federation,   South Africa,   United Kingdom,   United States
Taiwan
 
NCT01526057
B3281001
ICON 9002/010
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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