CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 597 enrolled
Drug / intervention
PF-06410293 +1 morebiological
Likely dose
PF-06410293 40 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/NCT02480153
NCT02480153Phase 3Completed
CompareCT.gov

A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE

Pfizer·interventional·Posted Jun 24, 2015·Updated Jan 23, 2019

In Brief

A Phase 3 clinical trial evaluating PF-06410293 and Adalimumab for Rheumatoid Arthritis. Completed, enrolled 597 participants across 183 sites in 24 countries.

Detailed Summary

The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate. In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Brazil, Bulgaria, Colombia, Czechia, Estonia, Georgia, Germany, Hungary, Japan, Lithuania, Mexico, New Zealand, Peru, Poland, Russia, Serbia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 24, 2015
Enrollment StartJun 25, 2015
Primary CompletionAug 31, 2016
Study CompletionDec 6, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.0 years ago

Interventions

PF-06410293biological

PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.

Adalimumabbiological

Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.