Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UCB Pharma SA
With
Parexel
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject must have a diagnosis of Rheumatoid Arthritis (RA) at Screening, as defined by the 2010 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aletaha D et al, 2010)
Subject must have a positive Rheumatoid Factor (RF) and/or a positive anti-Cyclic Citrullinated Peptide antibody (anti-CCP) as determined by the central laboratory at Screening
Subject must have moderate to severe RA disease at Screening and Baseline defined as:
Subject must have inadequately responded previously to Methotrexate (MTX)
Subject is using MTX 15 to 25 mg/week orally or subcutaneously at Screening and has used the same MTX regimen for a minimum of 28 days prior to Baseline
You may not be if
Subject has previously received any biological Disease Modifying Antirheumatic Drug (DMARD) or has received treatment with cyclophosphamide, chlorambucil, Janus Kinase, phosphodiesterase 4 inhibitors or investigational agents such as spleen tyrosine kinase
Diagnosis of any other inflammatory arthritis
Infected with Tuberculosis (TB) or high risk of acquiring TB infection
Subjects with concurrent acute or chronic viral hepatitis B or C infection
Subjects with a history of chronic or recurrent infections or subjects at high risk of infection
Use of prohibited medications like nonbiological DMARDs (excluding MTX), biological DMARDs excluding study medications, experimental therapy, IA hyaluronic acid
Clareo Health | Study to Assess the Short- and Long-term Efficacy of Certolizumab Pegol Plus Methotrexate Compared to Adalimumab Plus Methotrexate in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Inadequately Responding to Methotrexate
