A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis (C-early)

UCB

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: Methotrexate

Other: Placebo

Biological: Certolizumab Pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01519791

RA0055 Period 1

2011-001729-25 (EudraCT Number)

Details and patient eligibility

About

This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in combination with Methotrexate (MTX) for inducing and sustaining clinical response in the treatment of Disease Modifying Antirheumatic Drug (DMARD)-naïve adults with early active Rheumatoid Arthritis.

Enrollment

880 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects must have a time since diagnosis of adult-onset Rheumatoid Arthritis (RA) less than 1 year as defined by the 2010 ACR/EULAR classification criteria from Screening Visit
Positive Rheumatoid Factor (RF) and/or positive anticyclic Citrullinated Peptide Antibody (anti-CCP)
Active RA disease
DMARD-naïve
Subject is naïve to RA related biologics

Exclusion criteria

A diagnosis of any other inflammatory Arthritis
History of infected joint prosthesis, or other significant infection and other serious medical condition
Known Tuberculosis (TB) disease or high risk of acquiring TB infection