A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00175877
• Date of registration: 09/09/2005
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
• Scientific title: A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
• Date of first enrolment: June 2005
• Target sample size: 857
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00175877
• 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

Argentina, Australia, Belgium, Bulgaria, Canada, Chile, Croatia, Czech Republic, Czechia, Estonia, Finland, Former Serbia and Montenegro, France, Hungary, Israel, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Russian Federation, Serbia, Slovakia, Spain, Sweden, Ukraine, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

Patients must have either failed to achieve American College of Rheumatology 20 % Response
Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the
entire Week 52 assessment of C87027 [NCT00152386] trial.

Exclusion Criteria:

- A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or
Ankylosing Spondylitis)

- A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia)
that in the Investigator's opinion is symptomatic enough to interfere with evaluation
of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis

- Any concomitant biological therapy

- Any experimental therapy, within or outside a clinical trial



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 [Time Frame: From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)]

Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years [Time Frame: From first dose of CZP to the end of the open-label study (approximately 7 years)]

Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years [Time Frame: From first dose of CZP to the end of the open-label study (approximately 7 years)]

Secondary Outcome(s)

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144 [Time Frame: From Baseline of the preceding double-blind study to Week 144 of the open-label study]

Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS) [Time Frame: From Baseline of the preceding double-blind study to Week 96 of the open-label study]

Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192 [Time Frame: From Baseline of the preceding double-blind study to Week 192 of the open-label study]

Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192 [Time Frame: From Baseline of the preceding double-blind study to Week 192 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240 [Time Frame: From Baseline of the preceding double-blind study to Week 240 of the open-label study]

Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96 [Time Frame: From Baseline of the preceding double-blind study to Week 96 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48 [Time Frame: From Baseline of the preceding double-blind study to Week 48 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96 [Time Frame: From Baseline of the preceding double-blind study to Week 96 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48 [Time Frame: From Baseline of the preceding double-blind study to Week 48 of the open-label study]

Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192 [Time Frame: From Baseline of the preceding double-blind study to Week 192 of the open-label study]

Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240 [Time Frame: From Baseline of the preceding double-blind study to Week 240 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144 [Time Frame: From Baseline of the preceding double-blind study to Week 144 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144 [Time Frame: From Baseline of the preceding double-blind study to Week 144 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240 [Time Frame: From Baseline of the preceding double-blind study to Week 240 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal [Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)]

Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48 [Time Frame: From Baseline of the preceding double-blind study to Week 48 of the open-label study]

Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96 [Time Frame: From Baseline of the preceding double-blind study to Week 96 of the open-label study]

Secondary ID(s)

2005-001350-24

C87028

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/03/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00175877