Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (REALISTIC)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.
Full description
The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. In the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up to and including Week 10. The randomization will be stratified according to the three factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor (anti-TNF) use (Yes or No), and disease duration categories (< 2 years or ≥ 2 years). From Week 12 all patients remaining in the study receive open-label CZP for a minimum 16 additional weeks until CZP is commercially available.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adult patient with established moderate to severe rheumatoid arthritis
Exclusion criteria
- All concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trials
Trial design
Primary purpose
Allocation
Interventional model
Masking
1,648 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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