CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 220 enrolled
Drug / intervention
PF-05280586 +2 morebiological
Likely dose
PF-05280586 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01526057
NCT01526057Phase 2Completed
CompareCT.gov

A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES

Pfizer·interventional·Posted Feb 3, 2012·Updated Nov 19, 2019

In Brief

A Phase 2 clinical trial evaluating PF-05280586, MabThera, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 220 participants across 84 sites in 10 countries.

Detailed Summary

In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Canada, Colombia, Germany, Israel, Mexico, Russia, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2012
Enrollment StartMar 20, 2012
Primary CompletionAug 13, 2013
Study CompletionMay 7, 2014
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.4 years ago

Interventions

PF-05280586biological

1000 mg, IV on days 1 and 15

MabTherabiological

1000 mg, IV on days 1 and 15

Rituxanbiological

1000 mg, IV on days 1 and 15