Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).

Key facts

Study ID

NCT00753454

Run by

UCB Pharma

People needed

168

Starts

2008-09-01

Expected to finish

2011-05-01

Last updated by the study team

2018-08-01

Who can join

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

You may qualify if…

• Patients must be able to understand the written Informed Consent Form (ICF)
• Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
• Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
• Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
• Patients must be willing to comply with protocol

You may not qualify if…

• Patients must not have a diagnosis of any other inflammatory Arthritis
• Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
• Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
• Patients who do not meet the Medical History Exclusion criteria, as defined per protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Huntington Beach, California, United States
• Study site — La Jolla, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Desert, California, United States
• Study site — San Diego, California, United States
• Study site — Aventura, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jupiter, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Morton Grove, Illinois, United States
• Study site — Vernon Hills, Illinois, United States
• Study site — Lexington, Kentucky, United States
• Study site — Haverhill, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Rochester, Minnesota, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Reno, Nevada, United States

Full record on ClinicalTrials.gov

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