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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01526057
First received: February 1, 2012
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Biological: PF-05280586
Biological: MabThera
Biological: Rituxan
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetic parameter Cmax [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
  • Pharmacokinetic parameter AUC 0-∞ [ Time Frame: Week 25 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameter AUC 0-T [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
  • CD19+ B-cell count and circulating IgM. [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical response based on American College of Rheumatology Change from baseline in ACR 20, 50, 70 response. [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
  • Patient reported outcome measures - self-assessed disability index of the Health Assessment Questionnaire. [ Time Frame: Week 25 ] [ Designated as safety issue: No ]
  • Detection of anti-drug antibodies measured by specific assay. [ Time Frame: Week 25 ] [ Designated as safety issue: Yes ]

Enrollment: 222
Study Start Date: March 2012
Study Completion Date: May 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526057

  Show 71 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01526057     History of Changes
Other Study ID Numbers: B3281001, ICON 9002/010
Study First Received: February 1, 2012
Last Updated: September 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
rheumatoid arthritis
rituximab
methotrexate
anti-TNF

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014