Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

The primary purpose of this study is to obtain long-term safety data with CZP in patients with Rheumatoid Arthritis (RA). Additional objectives are to assess the dose and type of Arthritis medication(s) utilized by patients, and to assess the long-term impact of CZP on physical function. Treatment will continue up to approval of a marketing application for this product.

Key facts

Study ID

NCT00160693

Run by

UCB Pharma

People needed

402

Starts

2003-03-01

Expected to finish

2011-02-01

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…

• Participation in CZP trial C87014 or C87011
• If female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
• Must have provided written informed consent before undergoing any study procedures

You may not qualify if…

• History (Hx) of chronic infection, serious or life-threatening infection - (including Herpes Zoster) within 6 months prior, or any current symptom indicating infection
• Current or recent Hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
• Any finding indicative of Tuberculosis at end of previous study
• Known HIV infection
• Persistently abnormal AST (Aspartate Aminotransferase) or ALT (Alanine Aminotransferase) results (> 2 times upper limit of normal)
• Hemoglobin (Hgb) levels < 9 g/dL or Hematocrit < 30 %
• Total White Blood Cell (WBC) count of < 3.0 x 100/L (< 3000/mm\^3)
• Platelet count < 100 x 100 L (100,000/mm\^3)
• Serum creatinine > 1.5 times upper limit of normal based on patient age and sex
• Receipt of any biological therapies for RA in 6 months prior to study entry or any prior treatment (tx) with Tumor Necrosis Factor (TNF) blocking agent (excluding CDP870)
• Receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to Baseline
• Any other condition which the Principal Investigator judges would make patient unsuitable for study participation

Where it is running

• Study site — Paradise Valley, Arizona, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Aventura, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Springfield, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Wheaton, Maryland, United States
• Study site — Fall River, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Dayton, Ohio, United States
• Study site — Erie, Pennsylvania, United States
• Study site — West Reading, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Duncanville, Texas, United States
• Study site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.