PK Similarity Prospective Phase 3 Study in Patients With Rheumatoid Arthritis
This trial is active, not recruiting.
|Treatments||ct-p10, rituxan, mabthera|
|Start date||May 2014|
|End date||January 2017|
|Trial size||300 participants|
|Trial identifier||NCT02149121, 2013-004555-21, CT-P10 3.2|
This is a Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety between CT-P10, Rituxan and MabThera in Patients with Rheumatoid Arthritis.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: over the first 24 weeks
time frame: at Week 24
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: 1. Patient is male or female between 18 and 75 years old, inclusive. 2. Patient has a diagnosis of RA according to the revised 1987 ACR classification criteria (Arnett et al 1988) for at least 6 months prior to randomization. 3. Patient has active disease as defined by the presence of 6 or more swollen joints (of 66 assessed) and 6 or more tender joints (of 68 assessed), and serum CRP ≥1.5 mg/dL (≥15 mg/L) or an ESR ≥28 mm/hour. 4. Patient has experienced an inadequate response to previous or current treatment with the anti-TNF agents infliximab 5. Patient has a proper discontinuation period after treatment with interleukin-1 receptor (IL-1R) antagonist, interleukin-6 receptor (IL-6R) antibody, or abatacept. Exclusion Criteria: 1. Patient has taken more than 2 biologic agents. 2. Patient has previously been administered Rituximab or participated in a Rituximab biosimilar study. 3. Patient has allergies or hypersensitivity to murine, chimeric, human, or humanized proteins. 4. Patient has current or past history of chronic infection with hepatitis B, hepatitis C, or infection with human immunodeficiency virus (HIV)-1 or -2 or who has a positive result to the screening test for these infections. 5. Patient has an infection requiring oral antibiotics 2 weeks before randomization, parenteral injection of antibiotics 4 weeks before randomization, other serious infection 6 months before randomization, a history of recurrent herpes zoster or other chronic or recurrent infection 6 weeks before randomization.
|Official title||A Randomized, Controlled, Double-Blind, Parallel-Group, Phase 3 Study to Compare the Pharmacokinetics, Efficacy and Safety Between CT-P10, Rituxan and MabThera in Patients With Rheumatoid Arthritis|
|Principal investigator||DaeHyun Yoo, M.D., Ph.D|
Call for more information