At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 132 enrolled
Drug / intervention
Certolizumab pegolbiological
Likely dose
Certolizumab pegol 1mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)
In Brief
A Phase 4 clinical trial evaluating Certolizumab pegol for Rheumatoid Arthritis. Completed, enrolled 132 participants across 18 sites.
Detailed Summary
The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesItaly
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartDec 2011
Primary CompletionMay 2015
TodayJul 2026
First PostedSep 29, 2011
Enrollment StartDec 1, 2011
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.8 years ago
Interventions
Certolizumab pegolbiological
Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.