Status:
COMPLETED
Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis
Lead Sponsor:
UCB Pharma
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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(...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00160693
Start Date
March 1 2003
End Date
February 1 2011
Last Update
August 1 2018
Active Locations (61)
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1
Huntsville, Alabama, United States
2
Paradise Valley, Arizona, United States
3
Washington D.C., District of Columbia, United States
4
Aventura, Florida, United States