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

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35294 United States
Contact
1-800-718-1021
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.

NCT01643928
Pfizer
Completed
Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

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Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
Extension Study Evaluating Treatment With Pf-05280586 Versus Rituximab In Subjects With Active Rheumatoid Arthritis Who Have Participated In Other Pf-05280586 Clinical Trials
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
185
March 14, 2016
March 14, 2016   (Final data collection date for primary outcome measure)

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.
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
Switzerland,   Ukraine
 
NCT01643928
B3281004
ICON 9002/0101
2012-003223-38 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2017

ICMJE     Data element required by the

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

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