MedTrace Logo

A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

NCT02222493 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2018-05-30

Study results available
· View outcomes & findings →

Summary

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

Conditions

Interventions

BIOLOGICAL

PF-06438179

PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

BIOLOGICAL

Infliximab

Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-26
Primary Completion
2016-06-29
Completion
2017-06-01

Countries

  • United States
  • Australia
  • Bosnia and Herzegovina
  • Brazil
  • Bulgaria
  • Canada
  • Czechia
  • Georgia
  • Germany
  • Guatemala
  • Hungary
  • Israel
  • Japan
  • Jordan
  • Lithuania
  • Mexico
  • Morocco
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Tunisia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02222493 on ClinicalTrials.gov