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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00160693
• Date of registration: 06/09/2005
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: March 2003
• Target sample size: 402
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00160693
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Czech Republic, Czechia, Germany, Ireland, United Kingdom, United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] (UCB)

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: Certolizumab Pegol

Primary Outcome(s)

Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study Period of 8 Years [Time Frame: From First Visit (Week 0 in this study) up to 8 years]

Percentage of Subjects With at Least One Adverse Event (AE) During the Study Period of 8 Years [Time Frame: From first dose of CZP up to 8 years]

Secondary Outcome(s)

Percentage of Subjects Meeting the American College of Rheumatology 70% Response Criteria (ACR70) at Completion Visit or Early Withdrawal Visit [Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years]

Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Completion Visit or Early Withdrawal Visit [Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years]

Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 100 [Time Frame: From Baseline to Week 100]

Percentage of Subjects Utilizing Common Additional Arthritis Medications During the Study Period of 8 Years [Time Frame: From First Visit (Week 0 in this study) up to 8 years]

Percentage of Subjects Who Withdrew Due to Lack of Efficacy During the Study Period of 8 Years [Time Frame: From First Visit (Week 0 in this study) up to 8 years]

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ- DI) at Completion Visit or Early Withdrawal Visit [Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years]

Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 256 [Time Frame: From Baseline to Week 256]

Percentage of Subjects Meeting the American College of Rheumatology 50% Response Criteria (ACR50) at Completion Visit or Early Withdrawal Visit [Time Frame: From Baseline to Completion Visit/ early Withdrawal Visit, up to 8 years]

Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 160 [Time Frame: From Baseline to Week 160]

Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 52 [Time Frame: From Baseline to Week 52]

Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 208 [Time Frame: From Baseline to Week 208]

Percentage of Subjects Meeting the American College of Rheumatology 20% Response Criteria (ACR20) at Week 316 [Time Frame: From Baseline to Week 316]

Secondary ID(s)

C87015

2005-002617-21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/07/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00160693