At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 567 enrolled
Drug / intervention
Certolizumab Pegolbiological
Likely dose
Certolizumab pegol 400 mg subcutaneously every 2 weeks for at least 6 months, then 200 mg every 2 weeksAI-extracted
Key inclusion· 1
- ✓Patients must have either failed to achieve ACR20 response at Weeks 12 and 14 in prior C87050 trial, or completed the entire Week 24 assessment of C87050 trial
Key exclusion· 4
- ✕Any diagnosis of other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis)
- ✕Secondary non-inflammatory arthritis (e.g., osteoarthritis or fibromyalgia) symptomatic enough to interfere with evaluation of certolizumab pegol effect on primary RA diagnosis
- ✕Any 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-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050
In Brief
A Phase 3 clinical trial evaluating Certolizumab Pegol for Rheumatoid Arthritis. Completed, enrolled 567 participants across 67 sites in 13 countries.
Detailed Summary
An open ended study in which patients who completed the preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBulgaria, Croatia, Czechia, Estonia, Israel, Latvia, Lithuania, Poland, Russia, Serbia, Slovakia, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2005
Enrollment StartNov 2005
Primary CompletionFeb 2012
TodayJul 2026
First PostedSep 12, 2005
Enrollment StartNov 1, 2005
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago
Interventions
Certolizumab Pegolbiological
Strength and Form: 1 ml of Liquid product 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.