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

NCT01643928

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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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

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


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
Official Title  ICMJE EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Rituximab-Pfizer
    Intervention: Biological: Rituximab-Pfizer (PF-05280586) x 3 courses
  • Active Comparator: Rituximab-EU+Rituximab-Pfizer
    Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
    Intervention: Biological: Rituximab-EU+ Rituximab-Pfizer x 2 Courses
  • Active Comparator: Rituximab-US+Rituximab-Pfizer
    Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.
    Intervention: Biological: Rituximab-US + Rituximab-Pfizer x 2 Courses
Publications * Cohen SB, Burgos-Vargas R, Emery P, Jin B, Cronenberger C, Vázquez-Abad MD. Extension Study of PF-05280586, a Potential Rituximab Biosimilar, Versus Rituximab in Subjects With Active Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2018 Nov;70(11):1598-1606. doi: 10.1002/acr.23586.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2017)
185
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2012)
157
Actual Study Completion Date  ICMJE March 14, 2016
Actual Primary Completion Date March 14, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Colombia,   Germany,   Israel,   Mexico,   Russian Federation,   South Africa,   United Kingdom,   United States
Removed Location Countries Switzerland,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT01643928
Other Study ID Numbers  ICMJE B3281004
ICON 9002/0101
2012-003223-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP