Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis
A Phase III, Multicenter, Open-Label Long-Term Study to Assess the Safety and Tolerability of CDP870 400 mg Subcutaneously Every 4 Weeks, in Subjects With Rheumatoid Arthritis
2 other identifiers
interventional
402
7 countries
61
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(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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Mar 2003
Longer than P75 for phase_3 rheumatoid-arthritis
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
July 9, 2012
CompletedAugust 1, 2018
March 1, 2018
7.9 years
September 6, 2005
February 15, 2012
July 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. First dose of CZP was at Baseline of one of the feeder studies C87011 \[NCT00548834\] or C87014 \[NCT00544154\] for subjects randomized to CZP, or at First Visit (Week 0) of this study for subjects randomized to Placebo.
From first dose of CZP up to 8 years
Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
From First Visit (Week 0 in this study) up to 8 years
Secondary Outcomes (12)
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52
From Baseline to Week 52
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100
From Baseline to Week 100
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160
From Baseline to Week 160
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208
From Baseline to Week 208
Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256
From Baseline to Week 256
- +7 more secondary outcomes
Study Arms (1)
Certolizumab Pegol
EXPERIMENTALInterventions
400 mg of Certolizumab Pegol subcutaneously every 4 Weeks
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (61)
Unknown Facility
Huntsville, Alabama, United States
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Paradise Valley, Arizona, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Clearwater, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Coeur d'Alene, Idaho, United States
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Springfield, Illinois, United States
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Wichita, Kansas, United States
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Wheaton, Maryland, United States
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Fall River, Massachusetts, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Charlotte, North Carolina, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Erie, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Charleston, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Duncanville, Texas, United States
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Lubbock, Texas, United States
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San Antonio, Texas, United States
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San Diego, Texas, United States
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Everett, Washington, United States
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Graz, Austria
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Klagenfurt, Austria
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Vienna, Austria
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Antwerp, Belgium
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Diepenbeek, Belgium
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Liège, Belgium
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Merksem, Belgium
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České Budějovice, Czechia
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Liberec, Czechia
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Ostrava Trebovice, Czechia
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Prague, Czechia
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Praha4 -KRC, Czechia
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Uherské Hradiště, Czechia
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Berlin, Germany
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Cologne, Germany
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Gortlitz, Germany
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Hamburg, Germany
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Jena, Germany
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Leipzig, Germany
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Ratingen, Germany
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Dublin, Ireland
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Waterford, Ireland
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Birmingham, United Kingdom
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Cannock, United Kingdom
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Colchester, United Kingdom
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Glasgow, United Kingdom
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Harrogate, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom
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Oxford, United Kingdom
Unknown Facility
Peterborough, United Kingdom
Related Publications (1)
Fleischmann R, van Vollenhoven RF, Vencovsky J, Alten R, Davies O, Mountian I, de Longueville M, Carter D, Choy E. Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients. Rheumatol Ther. 2017 Jun;4(1):57-69. doi: 10.1007/s40744-017-0060-8. Epub 2017 Mar 28.
PMID: 28353191RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB Clinical Trial Call Center
- Organization
- UCB
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 12, 2005
Study Start
March 1, 2003
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
August 1, 2018
Results First Posted
July 9, 2012
Record last verified: 2018-03