Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
NCT01643928
ABOUT THIS STUDY
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- 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.
- 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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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | 185 | ||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |