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 sustaining clinical response achieved in study RA0055 Period 1 \[NCT01519791\]. Subjects entering this study RA0055 Period 2 achieved sustained Low Disease Activity at Week 52 in study RA0055 Period 1.

Key facts

Study ID

NCT01521923

Run by

UCB Pharma

People needed

359

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…

• Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

You may not qualify if…

• Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

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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