Clinical trial NCT00160693: Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
America College of Rheumatology
Disease modifying anti-rheumatic drug
Certolizumab Pegol (CDP870)
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years
timeFrame: From first dose of CZP up to 8 years
measure: Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years
timeFrame: From First Visit (Week 0 in this study) up to 8 years
Secondary outcomes:
measure: Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52
timeFrame: From Baseline to Week 52
measure: Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100
timeFrame: From Baseline to Week 100
measure: Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160
timeFrame: From Baseline to Week 160
measure: Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208
timeFrame: From Baseline to Week 208
measure: Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256
timeFrame: From Baseline to Week 256
measure: Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316
timeFrame: From Baseline to Week 316
measure: Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit
timeFrame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
measure: Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit
timeFrame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
measure: Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit
timeFrame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit
timeFrame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years
measure: Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years
timeFrame: From First Visit (Week 0 in this study) up to 8 years
measure: Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years
timeFrame: From First Visit (Week 0 in this study) up to 8 years
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Paradise Valley
country: United States
state: Arizona
city: Washington
country: United States
state: District of Columbia
city: Aventura
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Coeur d'Alene
country: United States
state: Idaho
city: Springfield
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Wheaton
country: United States
state: Maryland
city: Fall River
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Charlotte
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Erie
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Duncanville
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Diego
country: United States
state: Texas
city: Everett
country: United States
state: Washington
city: Graz
country: Austria
city: Klagenfurt
country: Austria
city: Vienna
country: Austria
city: Antwerpen
country: Belgium
city: Diepenbeek
country: Belgium
city: Liege
country: Belgium
city: Merksem
country: Belgium
city: Ceske Budejovice
country: Czechia
city: Liberec
country: Czechia
city: Ostrava Trebovice
country: Czechia
city: Prague 2
country: Czechia
city: Praha4 -krc
country: Czechia
city: Uherske Hradiste
country: Czechia
city: Berlin
country: Germany
city: Gortlitz
country: Germany
city: Hamburg
country: Germany
city: Jena
country: Germany
city: Koln
country: Germany
city: Leipzig
country: Germany
city: Ratingen
country: Germany
city: Dublin
country: Ireland
city: Waterford
country: Ireland
city: Birmingham
country: United Kingdom
city: Cannock
country: United Kingdom
city: Colchester
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Harrogate
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Oxford
country: United Kingdom
city: Peterborough
country: United Kingdom
city: Wirral
country: United Kingdom
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: 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.