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Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01643928
First received: July 6, 2012
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.


Condition Intervention
Rheumatoid Arthritis
Biological: Rituximab-Pfizer (PF-05280586) x 3 courses
Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extension Study Evaluating Treatment With PF-05280586 Versus Rituximab In Subjects With Active Rheumatoid Arthritis Who Have Participated In Other PF-05280586 Trials

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of anti drug antibodies (ADA), including neutralizing antibodies, and drug concentrations. [ Time Frame: From Baseline up to 148 weeks ] [ Designated as safety issue: Yes ]
  • Cluster of differentiation 19 (CD19+) B cell count. [ Time Frame: From Baseline up to 148 weeks ] [ Designated as safety issue: Yes ]
  • Immunoglobulin G (IgG). [ Time Frame: From Baseline up to 96 weeks ] [ Designated as safety issue: Yes ]
  • Immunoglobulin M (IgM). [ Time Frame: From Baseline up to 96 weeks ] [ Designated as safety issue: Yes ]
  • Rheumatoid Factor (RF). [ Time Frame: From Baseline up to 96 weeks ] [ Designated as safety issue: Yes ]
  • Anti-cyclic Citrullinated Peptide (anti-CCP) and complement. [ Time Frame: From Baseline up to 96 weeks ] [ Designated as safety issue: Yes ]
  • Mean change from initial study baseline in Disease Activity Score (DAS28)-C-reactive protein (CRP). [ Time Frame: From initial study Baseline up to 96 weeks ] [ Designated as safety issue: No ]
  • Mean change from initial study baseline in European League Against Rheumatism (EULAR) response. [ Time Frame: From initial study Baseline up to 96 weeks ] [ Designated as safety issue: No ]
  • Mean change from initial study baseline in low disease activity state (LDAS) (</=3.2). [ Time Frame: From initial study Baseline up to 96 weeks ] [ Designated as safety issue: No ]
  • Mean change from initial study baseline in and DAS remission (<2.6). [ Time Frame: From initial study Baseline up to 96 weeks ] [ Designated as safety issue: No ]
  • American College of Rheumatology (ACR) response, calculated from initial study baseline. [ Time Frame: From Baseline up to 96 weeks ] [ Designated as safety issue: No ]
  • Change from initial study baseline in individual components of the ACR response. [ Time Frame: From initial study Baseline up to 96 weeks ] [ Designated as safety issue: No ]
  • Outcome measure using Health Assessment Questionnaire Disability Index (HAQ DI). [ Time Frame: From initial study Baseline up to 96 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 157
Study Start Date: August 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab-Pfizer Biological: Rituximab-Pfizer (PF-05280586) x 3 courses
1000 mg intravenous infusion [IV] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
Active Comparator: Rituximab-EU+Rituximab-Pfizer
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Active Comparator: Rituximab-US+Rituximab-Pfizer
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.
Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses

  Eligibility

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

Inclusion Criteria:

  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Participated for a minimum of 16 weeks after the initiation of the last course of treatment in a previous rheumatoid arthritis study in the rituximab-Pfizer program within the past 2 months.

Exclusion Criteria:

  • Investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the study.
  • Initiated treatment with investigational agents or other biologics (including Rituxan and MabThera) since participating in a previous rheumatoid arthritis study in the rituximab-Pfizer program.
  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: NCT01643928

  Show 72 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: NCT01643928     History of Changes
Other Study ID Numbers: B3281004, ICON 9002/0101
Study First Received: July 6, 2012
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
extension trial
rheumatoid arthritis
rituximab

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

ClinicalTrials.gov processed this record on July 22, 2014