At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 857 enrolled
Drug / intervention
Certolizumab Pegolbiological
Likely dose
400 mg subcutaneously every two weeks for at least 6 months, then 200 mg every two weeksAI-extracted
Key inclusion· 1
- ✓Failed to achieve ACR20 response at weeks 12 and 14 in prior C87027 trial, OR completed entire week 52 assessment of C87027 trial
Key exclusion· 4
- ✕Diagnosis of other inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis)
- ✕Secondary non-inflammatory arthritis (e.g., osteoarthritis, fibromyalgia) that is symptomatic enough to interfere with evaluation of CDP870 effect on rheumatoid arthritis
- ✕Concomitant biological therapy
- ✕Any experimental therapy within or outside a clinical trial
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Certolizumab Pegol for Rheumatoid Arthritis. Completed, enrolled 857 participants across 121 sites in 22 countries.
Detailed Summary
An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Australia, Belgium, Bulgaria, Canada, Chile, Croatia, Czechia, Estonia, Finland, France, Hungary, Israel, Latvia, Lithuania, Mexico, New Zealand, Russia, Serbia, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2005
First PostedSep 2005
Primary CompletionFeb 2012
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartJun 1, 2005
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 20.8 years ago
Interventions
Certolizumab Pegolbiological
Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection. Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks. Duration: Until end of study.