Phase 3 N=402 Treatment

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

Rheumatoid Arthritis

Bottom Line

View on ClinicalTrials.gov: NCT00160693 ↗

Enrolled (actual)

402

Serious AEs

45.8%

Results posted

Jul 2012

Primary outcome: Primary: Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years — 93.5 percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Certolizumab Pegol (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UCB Pharma
Primary completion: Feb 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years	93.5	—
PRIMARY Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years	24.9	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52	58.1	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100	60.0	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160	68.4	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208	72.6	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256	75.4	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316	76.4	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit	57.2	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit	27.6	—
SECONDARY Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit	7.7	—
SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit	-0.305	—
SECONDARY Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years	7.5	—
SECONDARY Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years	21.9; 22.9; 23.4; 65.2; 26.4; 60.9	—

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00160693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.