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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) (REFLECTIONS)

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. Identifier: NCT01526057
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : September 18, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: PF-05280586 Biological: MabThera Biological: Rituxan Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 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 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
Study Start Date : March 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: A - PF-05280586 Biological: PF-05280586
1000 mg, IV on days 1 and 15

Active Comparator: B - Rituximab EU Biological: MabThera
1000 mg, IV on days 1 and 15

Active Comparator: C- Rituximab-US Biological: Rituxan
1000 mg, IV on days 1 and 15

Primary Outcome Measures :
  1. Pharmacokinetic parameter Cmax [ Time Frame: Week 25 ]
  2. Pharmacokinetic parameter AUC 0-∞ [ Time Frame: Week 25 ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameter AUC 0-T [ Time Frame: Week 13 ]
  2. CD19+ B-cell count and circulating IgM. [ Time Frame: Week 25 ]
  3. Clinical response based on change from baseline in Disease Activity Score 28 - C-reactive protein (DAS28-CRP, including patient's global assessment of disease activity). [ Time Frame: Week 25 ]
  4. Clinical response based on American College of Rheumatology Change from baseline in ACR 20, 50, 70 response. [ Time Frame: Week 25 ]
  5. Patient reported outcome measures - self-assessed disability index of the Health Assessment Questionnaire. [ Time Frame: Week 25 ]
  6. Detection of anti-drug antibodies measured by specific assay. [ Time Frame: Week 25 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01526057

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Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT01526057     History of Changes
Other Study ID Numbers: B3281001
ICON 9002/010
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Pfizer:
rheumatoid arthritis

Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors