Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01643928 · ClinicalTrials.gov registry record · NA
Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)
A NA study, sponsored by Pfizer.
- Completed
- Registry status
- NA
- Development phase
- 185
- Enrollment target
NCT01643928: Completed NA study, sponsored by Pfizer.
NCT01643928 is a NA study that has completed, run by Pfizer. The registered enrollment target is 185 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01643928, a NA study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- NA
- Development phase
- 185 participants
- Enrollment target
Study 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.
Primary Outcome
Serum samples were collected to determine the presence of ADA using two validated assays, one specific for PF-05280586 and one specific for the licensed drug products. For participants assigned to PF-05280586 in Study B3281001, blood samples were screened for ADA using the assay specific to PF-05280586; if the blood samples were confirmed to be positive (+ve) for ADA against PF-05280586, the samples were also analyzed using the assay specific for the licensed drug products to assess cross-reacti
Interventions
- BIOLOGICAL Rituximab-Pfizer (PF-05280586) x 3 courses
- BIOLOGICAL Rituximab-EU+ Rituximab-Pfizer x 2 Courses
- BIOLOGICAL Rituximab-US + Rituximab-Pfizer x 2 Courses
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2012-08-16 |
| Est. Completion | 2016-03-14 |
| Phase | NA |
What the finished NCT01643928 record still lists
NCT01643928 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Rituximab-Pfizer (PF-05280586) x 3 courses is the first listed.
NCT01643928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01643928 about?
NCT01643928 is a clinical study titled "Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)". 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 ...
What is the current status of trial NCT01643928?
This trial is currently completed. It is a NA study. The enrollment target is 185 participants. The study started on 2012-08-16. Estimated completion is 2016-03-14.
What interventions are being tested in trial NCT01643928?
The interventions under investigation include: Rituximab-Pfizer (PF-05280586) x 3 courses (BIOLOGICAL), Rituximab-EU+ Rituximab-Pfizer x 2 Courses (BIOLOGICAL), Rituximab-US + Rituximab-Pfizer x 2 Courses (BIOLOGICAL).
Who is sponsoring clinical trial NCT01643928?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01643928's enrollment target sits among peer trials
185 580th of 2000 higher than 1,420 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04041154 · 185 participants · NA
Behavioral and Neural Representations of Subjective Effort Cost
- NCT04484272 · 185 participants · NA
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
- NCT05020860 · 185 participants · Phase 2
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
- NCT05793541 · 185 participants · NA
Just-in-time Interventions for Reducing Short-term Suicide Risk
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI