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

UCB

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: Certolizumab Pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00160693

C87015

2005-002617-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

402 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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