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

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01519791

Run by

UCB Pharma SA

People needed

880

Starts

2012-01-01

Expected to finish

2015-09-01

Last updated by the study team

2018-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 170 — Huntsville, Alabama, United States
• 180 — Mobile, Alabama, United States
• 247 — Glendale, Arizona, United States
• 165 — Paradise Valley, Arizona, United States
• 234 — Paradise Valley, Arizona, United States
• 243 — Phoenix, Arizona, United States
• 251 — Tucson, Arizona, United States
• 160 — Covina, California, United States
• 257 — Hemet, California, United States
• 159 — Los Angeles, California, United States
• 201 — San Leandro, California, United States
• 202 — Upland, California, United States
• 172 — Whittier, California, United States
• 190 — Fort Lauderdale, Florida, United States
• 196 — Jupiter, Florida, United States
• 238 — Lake Mary, Florida, United States
• 232 — Miami, Florida, United States
• 213 — Naples, Florida, United States
• 214 — Ocala, Florida, United States
• 237 — Orange Park, Florida, United States
• 255 — Orlando, Florida, United States
• 163 — Palm Harbor, Florida, United States
• 166 — Plantation, Florida, United States
• 192 — Sarasota, Florida, United States
• 209 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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